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Abstract Background Neurostimulation is a highly effective therapy for the treatment of chronic Intractable pain, however, due to the complexity of pain, measuring a subject’s long-term response to the therapy remains difficult. Frequent measurement of patient-reported outcomes (PROs) to reflect multiple aspects of subjects’ pain is a crucial step in determining therapy outcomes. However, collecting full-length PROs is burdensome for both patients and clinicians. The objective of this work is to identify the reduced set of questions from multiple validated PROs that can accurately characterize chronic pain patients’ responses to neurostimulation therapies. Methods Validated PROs were used to capture pain, physical function and disability, as well as psychometric, satisfaction, and global health metrics. PROs were collected from 509 patients implanted with Spinal Cord Stimulation (SCS) or Dorsal Root Ganglia (DRG) neurostimulators enrolled in the prospective, international, post-market REALITY study (NCT03876054, Registration Date: March 15, 2019). A combination of linear regression, Pearson’s correlation, and factor analysis were used to eliminate highly correlated questions and find the minimal meaningful set of questions within the predefined domains of each scale. Results The shortened versions of the questionnaires presented almost identical accuracy for classifying the therapy outcomes as compared to the validated full-length versions. In addition, principal component analysis was performed on all the PROs and showed a robust clustering of pain intensity, psychological factors, physical function, and sleep across multiple PROs. A selected set of questions captured from multiple PROs can provide adequate information for measuring neurostimulation therapy outcomes. Conclusions PROs are important subjective measures to evaluate the physiological and psychological aspects of pain. However, these measures are cumbersome to collect. These shorter and more targeted PROs could result in better patient engagement, and enhanced and more frequent data collection processes for digital health platforms that minimize patient burden while increasing therapeutic benefits for chronic pain patients.

Abstract Background Neurostimulation is an effective therapy for treating and management of refractory chronic pain. However, the complex nature of pain and infrequent in-clinic visits, determining subject’s long-term response to the therapy remains difficult. Frequent measurement of pain in this population can help with early diagnosis, disease progression monitoring, and evaluating long-term therapeutic efficacy. This paper compares the utilization of the common subjective patient-reported outcomes with objective measures captured through a wearable device for predicting the response to neurostimulation therapy. Method Data is from the ongoing international prospective post-market REALITY clinical study, which collects long-term patient-reported outcomes from 557 subjects implanted by Spinal Cord Stimulator (SCS) or Dorsal Root Ganglia (DRG) neurostimulators. The REALITY sub-study was designed for collecting additional wearables data on a subset of 20 participants implanted with SCS devices for up to six months post implantation. We first implemented a combination of dimensionality reduction algorithms and correlation analyses to explore the mathematical relationships between objective wearable data and subjective patient-reported outcomes. We then developed machine learning models to predict therapy outcome based on the subject’s response to the numerical rating scale (NRS) or patient global impression of change (PGIC). Results Principal component analysis showed that psychological aspects of pain were associated with heart rate variability, while movement-related measures were strongly associated with patient-reported outcomes related to physical function and social role participation. Our machine learning models using objective wearable data predicted PGIC and NRS outcomes with high accuracy without subjective data. The prediction accuracy was higher for PGIC compared with the NRS using subjective-only measures primarily driven by the patient satisfaction feature. Similarly, the PGIC questions reflect an overall change since the study onset and could be a better predictor of long-term neurostimulation therapy outcome. Conclusions The significance of this study is to introduce a novel use of wearable data collected from a subset of patients to capture multi-dimensional aspects of pain and compare the prediction power with the subjective data from a larger data set. The discovery of pain digital biomarkers could result in a better understanding of the patient’s response to therapy and their general well-being.

Background: Neurostimulation is a highly effective therapy for the treatment of chronic Intractable pain, however, due to the complexity of pain, measuring a subject's long-term response to the therapy remains difficult. Frequent measurement of patient-reported outcomes (PROs) to reflect multiple aspects of subjects' pain is a crucial step in determining therapy outcomes. However, collecting full-length PROs is burdensome for both patients and clinicians. The objective of this work is to identify the reduced set of questions from multiple validated PROs that can accurately characterize chronic pain patients' responses to neurostimulation therapies. Methods: Validated PROs were used to capture pain, physical function and disability, as well as psychometric, satisfaction, and global health metrics. PROs were collected from 509 patients implanted with Spinal Cord Stimulation (SCS) or Dorsal Root Ganglia (DRG) neurostimulators enrolled in the prospective, international, post-market REALITY study (NCT03876054, Registration Date: March 15, 2019). A combination of linear regression, Pearson's correlation, and factor analysis were used to eliminate highly correlated questions and find the minimal meaningful set of questions within the predefined domains of each scale. Results: The shortened versions of the questionnaires presented almost identical accuracy for classifying the therapy outcomes as compared to the validated full-length versions. In addition, principal component analysis was performed on all the PROs and showed a robust clustering of pain intensity, psychological factors, physical function, and sleep across multiple PROs. A selected set of questions captured from multiple PROs can provide adequate information for measuring neurostimulation therapy outcomes. Conclusions: PROs are important subjective measures to evaluate the physiological and psychological aspects of pain. However, these measures are cumbersome to collect. These shorter and more targeted PROs could result in better patient engagement, and enhanced and more frequent data collection processes for digital health platforms that minimize patient burden while increasing therapeutic benefits for chronic pain patients. [ABSTRACT FROM AUTHOR]

Background: Neurostimulation is an effective therapy for treating and management of refractory chronic pain. However, the complex nature of pain and infrequent in-clinic visits, determining subject's long-term response to the therapy remains difficult. Frequent measurement of pain in this population can help with early diagnosis, disease progression monitoring, and evaluating long-term therapeutic efficacy. This paper compares the utilization of the common subjective patient-reported outcomes with objective measures captured through a wearable device for predicting the response to neurostimulation therapy. Method: Data is from the ongoing international prospective post-market REALITY clinical study, which collects long-term patient-reported outcomes from 557 subjects implanted by Spinal Cord Stimulator (SCS) or Dorsal Root Ganglia (DRG) neurostimulators. The REALITY sub-study was designed for collecting additional wearables data on a subset of 20 participants implanted with SCS devices for up to six months post implantation. We first implemented a combination of dimensionality reduction algorithms and correlation analyses to explore the mathematical relationships between objective wearable data and subjective patient-reported outcomes. We then developed machine learning models to predict therapy outcome based on the subject's response to the numerical rating scale (NRS) or patient global impression of change (PGIC). Results: Principal component analysis showed that psychological aspects of pain were associated with heart rate variability, while movement-related measures were strongly associated with patient-reported outcomes related to physical function and social role participation. Our machine learning models using objective wearable data predicted PGIC and NRS outcomes with high accuracy without subjective data. The prediction accuracy was higher for PGIC compared with the NRS using subjective-only measures primarily driven by the patient satisfaction feature. Similarly, the PGIC questions reflect an overall change since the study onset and could be a better predictor of long-term neurostimulation therapy outcome. Conclusions: The significance of this study is to introduce a novel use of wearable data collected from a subset of patients to capture multi-dimensional aspects of pain and compare the prediction power with the subjective data from a larger data set. The discovery of pain digital biomarkers could result in a better understanding of the patient's response to therapy and their general well-being. [ABSTRACT FROM AUTHOR]

Introduction: Providing effective treatment for debilitating chronic pain is a challenge among many populations including military service members. Cognitive behavioral therapy for chronic pain (CBT-CP) is a leading psychological pain treatment. Pain catastrophizing is a pivotal mediator of pain-related outcomes. The purpose of this study was (1) to identify patient subgroups who differ in response to CBT-CP and (2) to explore the characteristics that define these patient subgroups. The overall goal was to obtain a better understanding of factors that may influence response to CBT-CP., Materials and Methods: This study was a secondary analysis of data from a clinical trial of 149 U.S. active duty service members with chronic pain. Participants underwent group-based CBT-CP for 6 weeks and completed pre- and posttreatment assessments. Finite mixture models were employed to identify subgroups in treatment response, with pain impact score as the primary outcome measure., Results: We identified two classes of nearly equal size with distinct pain impact responses. One class reported improved pain impact scores following CBT-CP. This improvement was significantly associated with lower (better) baseline depression scores and greater improvement in posttreatment pain catastrophizing. In contrast, the other class reported slightly worse mean pain impact scores following CBT-CP treatment; this response was not related to baseline depression or change in pain catastrophizing., Conclusions: Our findings demonstrate that a sizable proportion of individuals with chronic pain may not respond to group-based CBT-CP and may require a more individualized treatment approach., (© The Association of Military Surgeons of the United States 2024. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site–for further information please contact journals.permissions@oup.com.)

Introduction: Chronic primary pelvic pain syndrome (CPPPS) is a condition characterised by pain in the pelvic area together with lower urinary tract symptoms. Pathophysiology remains largely unclear. Common treatment modalities show unsatisfactory results. This randomised controlled trial aims to establish the long-term effect of pelvic floor re-education using biofeedback and home training for men with CPPPS evaluated with the National Institute of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) and to explore if outcomes can be correlated to changes in objective urodynamic measures., Methods and Analysis: After inclusion all study participants will go through baseline testing consisting of urodynamic evaluation, assessment of the pelvic floor muscles and the NIH-CPSI questionnaire, thereafter, randomised to intervention or control group. Intervention consists of short daily session of pelvic floor muscle training, during 6 months. Parallelly with starting up, the intervention group will attend four bio-feedback sessions, to guide and facilitate the training. The training will initially aim on how to correctly activate and relax the pelvic floor muscles with functional enhancement further on. The control group will be offered to enter the intervention group after the 6-month assessment. The outcome will be assessed by repeating the baseline tests at 3, 6 and 12 months.To compare the primary outcome, the NIH-CPSI questionnaire between and within the two groups will be analysed. Secondary outcomes are the differences in sub-score reduction according to the domains in the NIH-CPSI questionnaire, the manual assessment of the pelvic floor muscles and numerical results from the urodynamic testing. The correlation between subjective and objective outcomes will be analysed., Ethics and Dissemination: The study obtained ethical approval from the Swedish Ethical Review Authority (2023-00286-01). The study result will be published in a peer-reviewed medical journal and presented at an international conference., Trial Registration Number: This trial is registered at Clinicaltrials.gov (NCT06115083)., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: Chronic low back pain (CLBP) is a prevalent health condition worldwide. Several therapeutic interventions aim to improve CLBP. Pain Neuroscience Education (PNE) helps patients better understand their pain from biological and physiological perspectives, which clinicians use to reduce pain and disability in patients with chronic musculoskeletal conditions. Neuromuscular exercises (NMS) are also treatments adopted in CLBP. This study will investigate whether PNE combined with an NMS program improves pain, functional and psychological outcomes more than NMS alone in patients with CLBP., Methods: In this single-blind randomized controlled trial, 60 patients (male and female; age range, 30-60 years) diagnosed with CLBP will be randomly assigned to one of the following groups: (1) PNE plus NMS (n = 30; 24 sessions of PNE plus NMS in a total of 8 weeks, 3 each week), and (2) NMS alone (n = 30; 24 sessions of NMS sessions in a total of 8 weeks, 3 each week). Outcome assessors will be blinded to the group allocation. The primary outcome will be pain. Secondary outcomes will be disability, fear-avoidance beliefs about work and physical activity, self-efficacy, exercise anxiety, and kinesiophobia. Outcomes will be assessed at baseline, after 8 weeks of intervention, and 6 months post-intervention., Discussion: The findings of this RCT will help shed light on new treatment strategies to address the biopsychosocial dimensions of CLBP. The study protocol will be conducted in a clinical setting, offering the opportunity for future implementation in healthcare systems. Moreover, it will help clarify whether a combined treatment (PNE with NMS) is more effective than NMS alone for improving pain, functional and psychological outcomes in CLBP., Trial Registration: Study registration: The study was prospectively registered in the Iranian Registry of Clinical Trials-IRCT20190427043384N2 (https://www.irct.ir/trial/69146). Registered on March 17, 2023., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Alvani et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Importance: Chronic low back pain (CLBP) is a common condition with substantial impact on patients, in the form of physical and emotional suffering; health care costs; productivity; and health care professional burden. Although clinical guidelines recommend use of nonpharmacologic treatments first, such as yoga, there is a gap between guidelines and implementation in clinical practice., Objective: To compare the effects of virtual yoga classes vs a wait-list control on CLBP intensity, back-related function, sleep quality, and pain medication use., Design, Setting, and Participants: Single-blinded, 24-week, 2-arm, randomized clinical trial conducted from May 3, 2022, through May 23, 2023, comparing live streamed yoga classes (the yoga now group) with a wait-list control (the yoga later group, in which participants were offered the virtual intervention after the study but without assessments) among adults with CLBP. Adults 18 to 64 years of age with CLBP were recruited from the Cleveland Clinic Employee Health Plan, a large health system self-insured health plan. Inclusion criteria included a mean LBP intensity score of at least 4 on an 11-point numerical rating scale (scores ranged from 0 to 10, with higher scores indicating worse pain) and daily back pain interference about half or more of the days., Intervention: Twelve consecutive weekly, 60-minute, virtual, live streamed hatha yoga group classes., Main Outcomes and Measures: Coprimary outcomes were mean pain intensity in the previous week on the 11-point numerical rating scale and back-related function as assessed using the 23-point modified Roland Morris Disability Questionnaire ([RMDQ], with higher scores reflecting poorer function) at 12 weeks. Secondary and exploratory outcomes included these measures at 24 weeks, pain medication use, and PROMIS sleep quality assessed using the Sleep Disturbance Short Form 8a, item 1 (scores ranged from 0 to 4, with higher scores reflecting better sleep quality). Analyses followed the intention-to-treat principle., Results: Among 140 participants enrolled (yoga now = 71; yoga later = 69), the mean (SD) age was 47.8 (11.7) years and most were female (113 [80.7%]) and college-educated (103 [73.5%]). Mean (SD) baseline pain intensity (5.7 [1.5]) and RMDQ ([12.1 [4.4]) scores reflected moderate back pain and impairment. At week 12, yoga now compared with yoga later had greater reductions in mean pain intensity (-1.5 [95% CI, -2.2 to -0.7] points; P < .001) and mean RMDQ (-2.8 [95% CI, -4.3 to -1.3] points; P < .001) scores. At 24 weeks, the improvements in pain (mean change, -2.3 [95% CI, -3.1 to -1.6] points; P < .001) and RMDQ (mean change, -4.6 [95% CI, -6.1 to -3.1] points; P < .001) scores were sustained. At 12 weeks, yoga now participants reported 21.4 (95% CI, 5.2-37.6) absolute percentage points less use of any analgesic medication during the past week than yoga later participants and at 24 weeks, 21.2 absolute percentage points (95% CI, 5.2%-37.3%). Improvements in sleep quality were greater for participants in yoga now than among participants in yoga later at 12 weeks (mean change, 0.4 [95% CI, 0.1-0.7] points; P = .008) and 24 weeks (mean change, 0.4 [95% CI, 0.1-0.7] points; P = .005)., Conclusions and Relevance: Results of this randomized clinical trial of 140 adults with CLBP who were members of a large health system self-insured health plan suggest that virtual yoga classes may be a feasible, safe, and effective treatment option., Trial Registration: ClinicalTrials.gov Identifier: NCT05319691.

Introduction: Significant interindividual variability in spinal cord stimulation (SCS) outcomes exists. Due to its high cost and risks of complications, criteria to guide patient selection for SCS trials and their outcomes would be helpful. With increased focus on the use of patient-reported outcomes to improve care, we aim to evaluate the National Institute of Health Patient Reported Outcome Measurement Information System measures for an association with successful SCS trials in patients with persistent pain., Methods: Our prospective, observational study enrolled 60 patients with persistent pain who underwent an SCS trial. Patients completed demographic and Patient Reported Outcome Measurement Information System computer adaptive test (PROMIS CAT) assessments to measure self-reported pain interference, depression, anxiety, physical functioning, and sleep disturbance at the time they presented for placement of their trial device., Results: Of the 58 patients who underwent successful electrode placement, 11 had an unsuccessful trial. There were no differences in patient demographics between patients with a successful and an unsuccessful trial. Patients who had a successful SCS trial reported lower pre-trial levels of anxiety, depression, and sleep disturbance and decreased post-trial levels of depression, sleep disturbance, and pain interference., Conclusions: We found that patients with high levels of depression, anxiety, and sleep disturbance using the PROMIS CAT were predictive of unsuccessful trials. In addition, we found that patients with successful SCS trials reported lower levels of these domains on PROMIS CAT administered at the end of the trial., Competing Interests: Competing interests: LB, GLS, JS, and KS have no conflicts to disclose. JHG is a consultant for Saluda Medical, Abbott, and Stratus Medical and the recipient of research support paid to the institution by SPR Therapeutics and Mainstay Medical. NP is an employee of Eli Lilly and Company., (© American Society of Regional Anesthesia & Pain Medicine 2024. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ.)

OBJECTIVE: To investigate whether improvements in forward bending were related to improvements in pain and disability in people with chronic low back pain (CLBP) who were undergoing Cognitive Functional Therapy (CFT). DESIGN: Longitudinal observational study. METHODS: Two hundred and sixty-one participants with CLBP received CFT. Forward bending was assessed at each treatment session over 13 weeks (an average of 4.3 timepoints per participant [range, 1-8]). Spinal range of motion (ROM) and velocity were recorded using 2 inertial measurement units located at T12 and S2. Participants reported (1) average pain intensity (0-10 scale) (pain) and (2) pain-related activity limitation (Roland Morris Disability Questionnaire [disability]) via online questionnaires at 0, 3, 6, and 13 weeks. Multivariate multilevel models were used to evaluate associations between individual rates of change over time for 3 spinal movement measures (trunk velocity, trunk ROM, lumbar ROM) and pain/disability. RESULTS: Strong correlations were observed for increased trunk velocity with reduced pain ( r = -0.81; 95% CI: -0.98, -0.05) and with reduced disability ( r = -0.77; 95% CI: -0.95, -0.22). Moderate correlations were observed between increased trunk ROM with reduced pain ( r = - 0.37; 95% CI: -0.67, 0.04) and with reduced disability ( r = - 0.32; 95% CI: -0.6, 0.03). There was no evidence of association between changes in lumbar ROM and pain ( r = - 0.46; 95% CI: -0.90, 0.44) or disability ( r = - 0.01; 95% CI: -0.56, 0.55). CONCLUSION: Reductions in pain and disability were strongly correlated with increased trunk velocity in people with CLBP who were undergoing CFT. These findings are consistent with CFT that explicitly trains "nonprotective" spinal movement. J Orthop Sports Phys Ther 2024;54(11):721-731. Epub 7 October 2024. doi:10.2519/jospt.2024.12727 .

Some estimate that 1.5 billion people worldwide suffer from chronic pain. In the United States, chronic pain affects about 20% of the people with an annual cost of $600 billion. The most common type of chronic pain is chronic back pain. Since pain assessment and management is not always successful, this Editorial put some alternative pain modalities in the case managers' toolbox., Competing Interests: The editor reports no conflicts of interest., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: To rigorously evaluate the short-term and long-term effectiveness of Tuina (TN), alone and in combination with physiotherapy (PT), for Chronic nonspecific low back pain (CNLBP) through a comprehensive, high-quality clinical trial., Methods: This randomized, single-blind trial was conducted from September 2020 to July 2023, involving 204 CNLBP patients from the First Affiliated Hospital of Jinan University. Participants underwent a baseline assessment, 6 treatment sessions over 8 weeks, a post-treatment evaluation in the 9th week, and a 20-week follow-up. Participants were randomly assigned to TN, PT, or a combination of TN and PT (TP) groups. Each treatment involved 6 sessions with a minimum 7-day interval, each lasting 30 minutes. Primary outcome was the change in Visual Analog Scale (VAS) for pain. Secondary outcomes included the Oswestry Disability Index (ODI), 36-Item Short Form Health Survey (SF-36), Range of Motion (ROM) of the spine, Traditional Chinese Medicine Syndrome Scale (TCMSS), and adverse events (AE)., Results: Among the 204 participants, 67.16 % were female, and 88.73 % completed the 20-week follow-up. All groups showed significant reductions in VAS scores post-treatment and at follow-up. Secondary outcomes improved significantly, with notable decreases in ODI and TCMSS scores. Pairwise comparisons within groups indicated statistical significance, particularly in ODI scores, with clinical relevance. No significant differences were found between the groups. ROM and SF-36 showed statistical but not clinical significance. Only one AE (0.49 %) was reported, with no severe incidents., Conclusion: All treatment groups, including TN, TP, and PT, demonstrated significant reductions in VAS scores for CNLBP patients, with effects lasting up to 20 weeks. While TN and TP showed substantial improvements in secondary outcomes, particularly in ODI scores, no significant differences were found between the groups. These findings suggest that all treatments can be effective for managing CNLBP, supporting clinical practitioners in selecting appropriate interventions for patients, especially for those unable to engage in active exercises, utilizing passive movements like TN to enhance health outcomes., Competing Interests: Declaration of Competing Interest The authors declare that they have no competing interests., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Objectives: Insomnia and chronic pain are common symptoms in people with HIV. Poor sleep has been associated with chronic pain. While cognitive behavioral therapy for insomnia improves insomnia in clinical populations, there are barriers to people with HIV accessing treatment including the lack of trained providers and lengthy sessions. Only one study has examined the efficacy of brief behavioral treatment for insomnia (BBTI) in people with HIV. This study examined BBTI effects on sleep and pain in people with HIV., Methods: Ten adults with HIV and chronic pain completed a 4-week, telephone-delivered BBTI treatment. A control group (n = 10) completed a brief mindfulness training (BMT). The Insomnia Severity Index and Brief Pain Inventory were used to assess insomnia severity and pain outcomes, respectively., Results: There was a significant interaction between intervention and time on insomnia severity, F (2,14) = 5.7, p  = .02, partial η 2  = 0.45). The BBTI group demonstrated significant improvements in insomnia severity from pre- to post-intervention ( p  < .001) and from pre-intervention to one-month post-intervention ( p  = .001) compared to the BMT group. There was a significant interaction between intervention and time on pain interference, F (1,18) = 4.9, p  = .02, partial η 2  = 0.27). The BBTI group demonstrated a significant decrease in pain interference from pre- to post-intervention ( p  < .001) compared to the BMT group., Conclusions: This pilot study demonstrated that BBTI improved insomnia in people with HIV for up to one-month post-treatment. Novel preliminary evidence suggests that BBTI may also improve pain outcomes in people with HIV.

Objective: While there is sufficient evidence of Acceptance and Commitment Therapy's effectiveness in allowing patients to deal with chronic pain, the effectiveness in cognitive fusion, one of the six core components of the Psychology Flexibility Model, has yet to be established. The aim of this article is to assess whether psychological interventions decrease cognitive fusion., Methods: The Web of Science, SCOPUS, Medline, and PsycINFO databases were searched for primary studies up to June 2024. Studies with a cognitive fusion measure in which chronic pain patients received a psychological intervention were included. A methodological quality scale was applied to the selected studies and the average effect sizes (Hedges g) were calculated., Results: This review included 18 articles with 24 studies (19 pre-post/follow-up studies and five randomized control trials). Cognitive fusion decreased significantly after the intervention. The effect sizes were small/medium at post-test, g = -0.39, p < .001, 95% CI [-0.52, -0.26]; and medium at long-term follow-up, g = -0.55, p < .001, 95% CI [-0.74, -0.36]. A similar tendency was found for studies with RCTs at post-test, g = -0.61, p = .006, 95% CI [-1.05, -0.17], short-term follow-up, g = -0.79, p < .001, 95% CI [-1.18, -0.40] and long-term follow-up, g = -0.58, p = .003, 95% CI [-0.95, -0.20]). Moderator variables such as unemployment, gender, pain intensity, level of depression before the intervention, and duration and intervention modality were identified., Conclusion: Psychological interventions tended to decrease cognitive fusion in chronic pain patients. Nonetheless, more clinical trials are needed to establish the role of cognitive fusion in psychological flexibility., Competing Interests: Declaration of competing interest The authors have no competing interests to report., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Chronic non-specific low back pain (CNSLBP) lacks identifiable anatomical pathology and effective pharmacological treatment. Alternative approaches in homeopathy, specifically clinical homeopathy, utilize ultra-diluted (potentized) biological products. In Brazil, standardized biotherapics from sheep tissues, particularly fifty-millesimal (LM) potencies of sheep Lumbar Vertebra , have shown promise in alleviating CNSLBP., Objectives: Our objective is to present the study protocol of a clinical trial that will assess the efficacy and safety of the biotherapic Lumbar Vertebra LM2 in the short-term management of CNSLBP and to estimate its therapeutic duration., Methods: A randomized, double-blind, crossover, placebo-controlled clinical trial spanning 8 weeks per participant was designed. Participants will include 120 individuals (aged 20 to 60 years) with clinically diagnosed CNSLBP by the study's physiotherapist. Exclusion criteria are radicular pain, signs of radiculopathy, specific lumbar spine disorders, pregnancy, or puerperium (up to 60 days after delivery). The medical intervention includes participants being randomly assigned to one of two treatment sequences: homeopathy-placebo or placebo-homeopathy. The treatments will consist of Lumbar Vertebra LM2 oral solution, topical cream, and indistinguishable placebos. Each treatment period will span 2 weeks, with a 4-week washout interval between them. Primary outcome is the assessment of changes in self-reported pain levels using the numeric rating scale (NRS) score, analyzed with a random effects model across both treatment periods. Secondary outcomes are assessment of changes in self-reported disability levels using the Oswestry Disability Index (ODI), analyzed with a random effects model across both treatment periods, and pain and disability variations, evaluated by the NRS score and ODI respectively, after the first and second treatment periods. Adverse events will be assessed at weeks 2 and 8. Pain medications will be used concomitantly. Adherence will be evaluated by the weight of medication returned/standard weight., Discussion: The BIOVERT (Bioactive Vertebra) trial protocol is designed to investigate a homeopathic strategy for short-term CNSLBP treatment. Favorable outcomes for homeopathy could prompt subsequent studies evaluating the long-term effectiveness of LM potencies of Lumbar Vertebra for CNSLBP., Trial Registration: UMIN Clinical Trials Registry - ID: UMIN000051957., Competing Interests: None declared., (Faculty of Homeopathy. This article is published by Thieme.)

Spinal cord stimulation (SCS) is a well-established treatment for chronic neuropathic pain. However, over- or underdelivery of the SCS may occur because the spacing between the stimulating electrodes and the spinal cord is not fixed; spacing changes with motion and postural shifts may result in variable delivery of the SCS dose and, in turn, a suboptimal therapy experience for the patient. The evoked compound action potential (ECAP)-a measure of neural activation-may be used as a control signal to adapt SCS parameters in real time to compensate for this variability. In this prospective, multicenter, randomized, single-blind, crossover trial, reduction in overstimulation intensity was used as a perceptual measure to evaluate a novel ECAP-controlled, closed-loop (CL) SCS algorithm relative to traditional open-loop (OL) SCS. The primary outcome used a Likert scale to assess sensation during activities of daily living with CL versus OL SCS. Of the 42 subjects in the intent-to-treat analysis set, 97.6% had a reduction in sensation with CL versus OL SCS. The primary objective was met as the lower confidence limit (87.4%) exceeded the performance goal of 50% (P < .001). A total of 88.1% (37/42) of subjects preferred CL and 11.9% (5/42) preferred OL SCS. SCS dose consistency during CL SCS was demonstrated by the reduced variability in ECAP amplitude with CL SCS (standard deviation: 8.72 µV) relative to OL SCS (standard deviation: 19.95 µV). Together, these results demonstrate that the ECAP-controlled, CL algorithm reduces or eliminates unwanted sensation, and thereby provides a more preferred and consistent SCS experience. PERSPECTIVE: Patients with chronic pain need durable and dependable options for pain relief. SCS is an important therapy option, and new technology advancements could improve long-term therapy use. CL SCS offers a preferred and more consistent therapy experience for patients that could lead to increased therapy utilization and reliable therapy outcomes., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Objectives: To survey, analyze and discuss the scientific evidence supporting the use of acupuncture and related techniques in the management of chronic pain in the pediatric population., Sources: A survey of databases (MEDLINE, Scopus and Scielo) was carried out with search strategies, following the PRISMA statement, without limits on publication dates and languages. Clinical studies (clinical trials, single-arm, and case series) were accepted for review if they included participants aged up to 22 years. Study quality was assessed by MMAT, and the randomized clinical trial was analyzed under the STRICTA criteria., Summary of the Findings: 2369 articles were retrieved. After excluding repetitions, 1335 underwent the initial selection. Only 16 articles were selected for full reading, of which 5 were included in the review, being two case series, two single-arm studies, and one randomized clinical trial. The articles were considered of good quality by the adopted criteria., Conclusion: The analyzed studies showed important clinical results such as the reduction of pain intensity, and improvement in school attendance and social life. However, there are many limitations in study design and sample size. Therefore, there is weak evidence to support the use of acupuncture in the context of pediatric chronic pain, but the positive results reinforce the need for further investigation of the topic with the conduct of larger and well-designed studies, to obtain more data and greater scientific conviction of the findings., Competing Interests: Conflicts of interest The authors declare no conflicts of interest., (Copyright © 2024 Sociedade Brasileira de Pediatria. Published by Elsevier Editora Ltda. All rights reserved.)

Background: To describe the frequency of primary care seeking for neck or back-related conditions among people with chronic neck and low back pain and to develop prediction models of primary care seeking and frequent visits., Methods: We included participants of the Trøndelag Health Study (HUNT4, 2017-19) in Norway who self-reported chronic neck and/or low back pain in the preceding year, and extracted data of primary care visits from the Norwegian primary healthcare registry. We investigated a total of 23 potential predictors and used multivariable logistic regression models to predict primary care seeking for neck or back-related conditions and frequent visits by healthcare provider (i.e., the highest quartile of number of visits)., Results: Among the 15,352 HUNT4 participants with chronic neck and/or low back pain, 6231 participants (40.6%) sought primary care for neck or back-related conditions (median = 5 visits, IQR 2-15) within 2 years after the study. Participants who consulted physical therapists sought care the most frequently (median = 10 visits, IQR 3-26). Discrimination of the best-fit prediction model of primary care seeking and frequent visits by healthcare provider, assessed by C-statistic, ranged from 0.66-0.76. Participants who made frequent primary care visits in the preceding year were highly likely to continue frequent care seeking in the following 2 years., Conclusions: Around 40% of people seek primary care for chronic neck and low back pain, and frequent care seeking may continue for years. Future studies should investigate strategies to reduce recurrent primary care visits, especially seeking physical therapist care, and promote self-management of chronic pain., Significance: People with chronic neck and low back pain who seek physical therapist care had the highest frequency of care seeking, underscoring the significant burden on healthcare systems. The high frequency of visits and associated healthcare expenditures highlight the critical need for effective and valuable primary care for chronic pain management. To mitigate recurrent visits and reduce costs, it is essential to provide patients with evidence-based treatments and self-management interventions., (© 2024 The Author(s). European Journal of Pain published by John Wiley & Sons Ltd on behalf of European Pain Federation ‐ EFIC ®.)

Purpose/objective: This study sought to develop and evaluate the psychometric properties of a brief measure of the quality of therapist treatment delivery that would be applicable for use across different types of psychosocial chronic pain treatments: the Therapist Quality Scale (TQS)., Research Method/design: An initial pool of 14 items was adapted from existing measures, with items selected that are relevant across interventions tested in a parent trial comparing an 8-week, group, Zoom-delivered mindfulness meditation, cognitive therapy, and behavioral activation for chronic back pain from which data for this study were obtained. A random selection of 25% of video-recorded sessions from each cohort was coded for therapist quality (two randomly selected sessions per group), with 66 sessions included in the final analyses ( n = 33 completed pairs). Items were coded on a 7-point Likert-type scale. Exploratory factor analysis (EFA) and reliability estimates were generated., Results: EFA showed a single-factor solution that provided a parsimonious explanation of the correlational structure for both sessions. Eight items with factor loadings of ≥ .60 in both sessions were selected to form the TQS. Reliability analyses demonstrated all items contributed to scale reliability, and internal consistency reliabilities were good (αs ≥ .86). Scores for the eight-item TQS from the two sessions were significantly correlated ( r = .59, p < .001)., Conclusions/implications: The TQS provides a brief measure with preliminary psychometric support that is applicable for use across different types of treatments to rate the quality of the therapist's delivery. The items assess quality in delivering specific techniques, maintaining session structure, and in developing and maintaining therapeutic rapport. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Purpose of Review: Mindfulness therapy is a widely used treatment for many diseases and has been shown to improve pain-related functions. There is growing support for the use of psychotherapy in the treatment of chronic pain. While studies have shown a positive effect of mindfulness therapy, it is important to consider psychosocial factors as there are still a small number of studies that question its effectiveness., Recent Findings: Based on current studies, mindfulness therapy involves cognitive factors related to chronic pain, both in terms of cognitive production and its impact on cognitive control. Psychological and neurobasic studies were reviewed to provide a deeper understanding of these components, which include thought inhibition, attention deficit, pain catastrophizing, and self-efficacy. Mindfulness therapy has the potential to normalize psychology and nerves, and increase internal and external connectivity to work networks related to stress perception, cognition, and emotion. However, further research is needed to fully understand its effects. By exploring the relationship between mindfulness therapy and chronic pain. This review provides a new avenue for future research in psychotherapy for patients with chronic pain., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Chronic neuropathic pain has been one of the prominent causes of disability, and acupuncture has shown promise in treatment. The present study aimed to characterize acupuncture modulation of chronic neuropathic pain and explore the related functional brain changes. Sixty chronic sciatica patients were divided into acupuncture- or sham acupuncture groups and received 10 sessions of treatment during 4 weeks. The visual analog scale for leg pain, oswestry disability index (ODI), and resting-state functional magnetic resonance images were assessed at baseline and after treatment. Then, fractional amplitudes of low-frequency fluctuations (fALFF) and support vector regression analyses were performed. Compared with sham acupuncture, acupuncture significantly improved symptoms, including visual analog scale for leg pain and ODI. In addition, acupuncture exhibited increased fALFF of the right superior parietal lobule (SPL) and right postcentral gyrus. Furthermore, the actual 4-week ODI values were positively correlated with the support vector regression-predicted values based on the right SPL fALFF and baseline clinical measurements. These results indicate that the spontaneous neural activity of the right SPL and right postcentral gyrus may be involved in the modulation of acupuncture in chronic neuropathic pain. In addition, the spontaneous neural activity of the right SPL might be used as the predictor of response to acupuncture therapy. PERSPECTIVE: This clinical neuroimaging study elucidated the neural basis of acupuncture in chronic sciatica. Neurological indicators and clinical measurements could be used as potential predictors of acupuncture response. This study combines neuroimaging and artificial intelligence techniques to highlight the potential of acupuncture for the treatment of chronic neuropathic pain. TRIAL REGISTRATION NUMBER: Chinese Clinical Trial Registry, ChiCTR2100044585, http://www.chictr.org.cn., (Copyright © 2024 United States Association for the Study of Pain, Inc. Published by Elsevier Inc. All rights reserved.)

This parallel, 2-arm, blinded, randomized controlled superiority trial examined whether, when added to usual care, active-electroencephalography neurofeedback (EEG NFB) was safe and more effective than sham control-EEG NFB for chronic pain. In total, 116 participants with chronic pain were randomly assigned (1:1) to usual care plus ≥32 sessions of active-EEG NFB upregulating relative alpha power over C4 or usual care plus ≥32 sessions of sham control-EEG NFB. Per-protocol analyses revealed no significant between-group differences in the primary outcome, Brief Pain Inventory average pain (mean difference [95% confidence interval]: -.04 [-.39 to .31], P = .90), or any secondary outcomes. However, 44% of participants in the active-EEG NFB group and 45% in the control-EEG NFB group reported at least a moderate (≥30%), clinically important improvement in Brief Pain Inventory average pain. The number of treatment-emergent adverse events were similar in both groups (P = .83), and none were serious. Post hoc analyses revealed similar upregulated relative alpha power in both groups during training, with concordant positive rewards delivered to the active-EEG group 100% of the time and the control-EEG group ∼25% of the time, suggesting a partially active sham intervention. When added to usual care, the active-EEG NFB intervention used in this study was not superior to the sham control-EEG NFB intervention. However, a large proportion of participants in both groups reported a clinically important reduction in pain intensity. A partially active sham intervention may have obscured between-group differences. The intervention was free of important side effects, with no safety concerns identified. PERSPECTIVE: This study is the first attempt at an appropriately blinded, randomized, sham-controlled trial of alpha EEG NFB for the treatment of chronic pain. The findings may interest people living with chronic pain, clinicians involved in chronic pain management, and may inform the design of future EEG NFB trials. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12621000667819., (Copyright © 2024 United States Association for the Study of Pain, Inc. Published by Elsevier Inc. All rights reserved.)

Purpose of Review: Cryoneurolysis refers to the process of reversibly ablating peripheral nerves with extremely cold temperatures to provide analgesia for weeks to months. With ultrasound-guidance or landmark-based techniques, it is an effective modality for managing both acute and chronic pain. In this review, we summarize the reported literature behind its potential applications and efficacy., Recent Findings: Here, we summarize several studies (from case reports to clinical trials) describing the use of ultrasound-guided and landmark-based cryoneurolysis for acute and chronic pain. Acute pain indications included pain related to knee arthroplasty, limb amputations, mastectomies, shoulder surgery, rib fractures, and burn. Chronic pain indications included chronic knee pain (due to osteoarthritis), shoulder pain, painful neuropathies, postmastectomy pain syndrome, phantom limb pain, facial pain/headaches, foot/ankle pain, inguinal pain, and sacroiliac joint pain. For both acute and chronic pain indications, more high quality randomized controlled clinical trials are needed to definitively assess the efficacy of cryoneurolysis versus other standard therapies for a multitude of pain conditions., (© 2024. The Author(s).)

Mindfulness-based interventions (MBIs) have been shown to improve chronic pain and associated conditions like depression, anxiety, and sleep disorders. However, there is limited research on how veterans with chronic pain apply mindfulness skills to manage pain in daily life. This cross-sectional study examined the association between applied mindfulness practice, pain, and several pain-related conditions among 1,737 veterans with chronic pain prior to enrollment in a trial of 2 MBIs. Applied mindfulness practice was assessed using the Applied Mindfulness Process Scale (AMPS). The outcomes included pain interference, pain intensity, pain catastrophizing, fatigue, sleep disturbance, anxiety, depression, post-traumatic stress disorder, physical function, and social participation. Higher overall AMPS scores, as well as the positive and negative emotional regulation subscales of the AMPS, were associated with less pain interference and catastrophizing, as well as better outcomes for all pain-related conditions. The positive emotional regulation subscale had the strongest associations with outcomes. There was no significant association between the AMPS and pain intensity. The results suggest applied mindfulness practice, especially positive emotional regulation, may improve pain and functioning. In addition, the AMPS shows promise as a process measure of mindfulness skills applied in daily life. Additional research is needed to examine different aspects of mindfulness in the context of MBIs. PERSPECTIVE: This article describes the relationship between applied mindfulness practice and pain-related outcomes, prior to a MBI, using a novel measure of mindfulness practice. These findings underscore the importance of measuring applied mindfulness practice prior to and during clinical interventions to treat chronic pain., (Published by Elsevier Inc.)

Abstract: Establishing clinically meaningful changes in pain experiences remains important for clinical trials of chronic pain treatments. Regulatory guidance and pain measurement initiatives have recommended including patient-reported global assessment measures (eg, Patient-Global Impression of Change [PGIC]) to aid interpretation of within-patient differences in domain-specific clinical trial outcomes (eg, pain intensity). The objectives of this systematic review were to determine the frequency of global assessment measures inclusion, types of measures, domains assessed, number and types of response options, and how measures were analyzed. Of 4172 abstracts screened across 6 pain specialty journals, we reviewed 96 clinical trials of chronic pain treatments. Fifty-two (54.2%) studies included a global assessment measure. The PGIC was most common (n = 28; 53.8%), with relatively infrequent use of other measures. The majority of studies that used a global assessment measure (n = 31; 59.6%) assessed change or improvement in an unspecified domain. Others assessed overall condition severity (n = 9; 17.3%), satisfaction (n = 8; 15.4%), or overall health status/recovery (n = 5; 9.6%). The number, range, and type of response options were variable and frequently not reported. Response options and reference periods even differed within the PGIC. Global assessment measures were most commonly analyzed as continuous variables (n = 24; 46.2%) or as dichotomous variables with positive categories combined to calculate the proportion of participants with a positive response to treatment (n = 18; 34.6%). This review highlights the substantial work necessary to clarify measurement and use of patient global assessment in chronic pain trials and provides short- and long-term considerations for measure selection, reporting and analysis, and measure development., (Copyright © 2024 International Association for the Study of Pain.)

Abstract: Endometriosis, a common cause for chronic pelvic pain, significantly affects quality of life, fertility, and overall productivity of those affected. Therapeutic options remain limited, and collating evidence on treatment efficacy is complicated. One reason could be the heterogeneity of assessed outcomes in nonsurgical clinical trials, impeding meaningful result comparisons. This systematic literature review examines outcome domains and patient-reported outcome measures (PROMs) used in clinical trials. Through comprehensive search of Embase, MEDLINE, and CENTRAL up until July 2022, we screened 1286 records, of which 191 were included in our analyses. Methodological quality (GRADE criteria), information about publication, patient population, and intervention were assessed, and domains as well as PROMs were extracted and analyzed. In accordance with IMMPACT domain framework, the domain pain was assessed in almost all studies (98.4%), followed by adverse events (73.8%). By contrast, assessment of physical functioning (29.8%), improvement and satisfaction (14.1%), and emotional functioning (6.8%) occurred less frequently. Studies of a better methodological quality tended to use more different domains. Nevertheless, combinations of more than 2 domains were rare, failing to comprehensively capture the bio-psycho-social aspects of endometriosis-associated pain. The PROMs used showed an even broader heterogeneity across all studies. Our findings underscore the large heterogeneity of assessed domains and PROMs in clinical pain-related endometriosis trials. This highlights the urgent need for a standardized approach to both, assessed domains and high-quality PROMs ideally realized through development and implementation of a core outcome set, encompassing the most pivotal domains and PROMs for both, stakeholders and patients., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the International Association for the Study of Pain.)

Introduction: Biopsychosocial approach in patients suffering chronic low back pain (CLBP) promotes pain self-management strategies. Current evidence recommends high dose of Pain Neuroscience Education (PNE) for clinically significant differences. However, the workload and time constraints experienced by healthcare providers impede the application of the recommended treatment regimen. In fact, Back School with a biomechanical model is the main approach to manage CLBP in public systems., Objective: The objective of this study is to explore the effect of a 60 min single session of PNE as an adjunct to back school on pain intensity and psychological variables patients with CLBP., Methods: A double-blind, two-arm randomized controlled clinical trial was conducted in patients with CLBP who attended back school sessions held in a Spanish public hospital. A total of 121 patients were randomized into control group, who received the Back School program during 5 weeks, and intervention group, who additionally received a single session of PNE. Patient-reported outcomes were the Numerical Pain Rating Scale, Central Sensitization Inventory, Pain Catastrophizing Scale, and Tampa Scale of Kinesiophobia, with a 12-week follow-up., Results: A total of 113 patients were analysed. Intervention and control group presented similar effects on pain and kinesiophobia. At follow-up, intervention group exhibited reduced sensitization and catastrophism scores compared with control, including the subscales. Additionally, PNE reduced the percentage of participants classified as having central sensitization compared with control., Conclusions: Adding a single PNE session in the back school program did not reduce pain but improved psychological factors as central sensitization and pain catastrophizing at medium-term. This study highlights the potential of PNE to optimize treatment strategies for CLBP, especially in public health centres where time resources are scarce., Significance Statement: Adding a single PNE session in the back school program did not reduce pain but improved psychological factors as central sensitization and pain catastrophism at medium-term., (© 2024 European Pain Federation ‐ EFIC ®.)

PURPOSE OF REVIEW: The purpose of this narrative review is to evaluate the efficacy of the most commonly studied intradiscal biologics used for the treatment and alleviation of chronic intractable discogenic low back pain. Additionally, it explores the therapeutic potential and durability of these novel treatment options. RECENT FINDINGS: Recently published literature highlights the therapeutic potential of intradiscal biologics, such as mesenchymal stem cells, platelet-rich plasma, and alpha-2-macroglobulin, in promoting chondrogenesis within the lumbar intervertebral discs to treat discogenic low back pain. Studies demonstrate significant improvements in pain relief, physical function, and quality of life post-treatment. A comprehensive review of the literature evaluating the efficacy of intradiscal biologics suggests some evidence supporting its efficacy in treating discogenic low back pain. However, more rigorous studies into mechanistic modulation and large-scale randomized trials as well as a more thorough understanding of adverse events will be instrumental for including these therapies into clinical practice paradigms., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

There is substantial access to care barriers for persons with chronic pain. Little is known about persons who do not receive treatment for chronic severe back pain as most studies rely on clinical samples. We sought to explore demographic, socioeconomic, and clinical characteristics of U.S. adults with chronic severe back pain who had not received pain care in the preceding 3 months. In this cross-sectional study, we used data from the 2019 National Health Interview Survey and identified persons who did/did not receive treatment (including self-management strategies) in the last 3 months for their chronic severe back pain. We used bivariate and multivariable analyses to explore factors associated with not receiving pain treatment. Almost 21% of persons with chronic severe back pain did not receive treatment in the past 3 months. The following were independently associated with not having treatment in the preceding 3 months: male sex (OR: 1.40, 95% CI: 1.11-1.76), living near or below the poverty level (OR: 1.92, 95% CI: 1.33-2.77), having less than a high school education (OR: 2.37, 95% CI: 1.52-3.68), not having insurance coverage (OR: 1.77, 95% CI: 1.21-2.59), living in the South (OR: 2.05, 95% CI: 1.40-3.00), and having heart disease (OR: 1.47, 95% CI: 1.11-1.93). Being a single parent, having depression, and multiple comorbid painful health conditions were associated with having treatment. Our conclusions are that one-fifth of persons with chronic severe back pain did not receive treatment for at least 3 months and socioeconomic factors were highly associated with not receiving treatment. PERSPECTIVE: In a nationally representative sample of persons with chronic severe back pain, one-fifth did not receive treatment for at least 3 months. Socioeconomic factors were highly associated with not receiving treatment. There is a need to implement solutions to reduce barriers to care., (Copyright © 2024 United States Association for the Study of Pain, Inc. Published by Elsevier Inc. All rights reserved.)

Aims: Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) prevalence varies from 8.4% to 25% of the male population and is associated with diminished health-related quality of life. Managing CP/CPPS remains challenging and there is not any common option to treat all patients effectively because of the complex disease nature. The currently available data for the extracorporeal shockwave therapy (eSWT) effect on pain relief and well-being were analyzed in the present study., Methods: We adhered to PRISMA 2022 guidelines for reporting the quantitative and qualitative data synthesis. A literature search was conducted in March 2023 using PubMed/Medline, Scopus, and Google Scholar. Randomized prospective studies of eSWT alone or eSWT plus conventional medicinal treatment were included. The risk of bias was estimated using the RoB 2.0. Primary outcomes were self-reported scores, including the NIH-CPSI questionnaire and VAS, at 1 month or 2, 3, and 6, months follow-up., Results: The CP/CPPS patients who receive eSWT have more pronounced pain relief and improvement of other subjective NIH-CPSI scores compared with control groups that received placebo or medication therapy. The effect of eSWT seems to be long-lasting and was confirmed in the 6-month follow-up (p < 0.01)., Conclusions: Based on the meta-analysis of accessible studies, we receive the equivalence eSWT applicability for the CP/CPPS treatment and can be offered to patients because of its noninvasiveness, high level of safety, and successful clinical results demonstrated in this analysis., (© 2024 Wiley Periodicals LLC.)

Background: Equestrians (horse riders) are more susceptible to low back pain than the general population due to loads placed on their bodies during the activity. A specific eight-week exercise intervention program targeting the muscles used during horse riding was implemented for a group of equestrians with low back pain., Methods: Volunteers were invited to participate in the study through social media posts in Melbourne, Australia. The participants were required to complete an exercise screening test prior to enrolment in the study to ensure they were suitable to participate in the iteration program. Participants then completed the Brief Pain Inventory (BPI) (Short Form) and Patient Specific Functional Scale (PSFS) before commencing the exercise program. These outcome measures were completed again by participants after completing the 8-week exercise program., Results: Nine equestrians (23-65 years of age; mean=43±14: average worst back pain on riding=7/10 with a range of 3-10/10) completed all outcome measures and the 8-week exercise intervention. Data indicate that all achieved improved pain severity, pain interference and riding functionality (P<0.01)., Conclusions: An eight-week exercise program may be beneficial in improving a sample of equestrians' chronic LBP symptoms. From a practitioner's perspective, the findings provide an indication as to suitable exercises to prescribe to an equestrian to help reduce their LBP.

Background: Approximately 20% to 50% of patients develop persistent pain after traumatic orthopaedic injuries. Psychosocial factors are an important predictor of persistent pain; however, there are no evidence-based, mind-body interventions to prevent persistent pain for this patient population., Questions/purposes: (1) Does the Toolkit for Optimal Recovery after Injury (TOR) achieve a priori feasibility benchmarks in a multisite randomized control trial (RCT)? (2) Does TOR demonstrate a preliminary effect in improving pain, as well as physical and emotional function?, Methods: This pilot RCT of TOR versus a minimally enhanced usual care comparison group (MEUC) was conducted among 195 adults with an acute orthopaedic traumatic injury at risk for persistent pain at four geographically diverse Level 1 trauma centers between October 2021 to August 2023. Fifty percent (97 of 195) of participants were randomized to TOR (mean age 43 ± 17 years; 67% [65 of 97] women) and 50% (98) to MEUC (mean age 45 ± 16 years; 67% [66 of 98] women). In TOR, 24% (23 of 97) of patients were lost to follow-up, whereas in the MEUC, 17% (17 of 98) were lost. At 4 weeks, 78% (76 of 97) of patients in TOR and 95% (93 of 98) in the MEUC completed the assessments; by 12 weeks, 76% (74 of 97) of patients in TOR and 83% (81 of 98) in the MEUC completed the assessments (all participants were still included in the analysis consistent with an intention-to-treat approach). The TOR has four weekly video-administered sessions that teach pain coping skills. The MEUC is an educational pamphlet. Both were delivered in addition to usual care. Primary outcomes were feasibility of recruitment (the percentage of patients who met study criteria and enrolled) and data collection, appropriateness of treatment (the percent of participants in TOR who score above the midpoint on the Credibility and Expectancy Scale), acceptability (the percentage of patients in TOR who attend at least three of four sessions), and treatment satisfaction (the percent of participants in TOR who score above the midpoint on the Client Satisfaction Scale). Secondary outcomes included additional feasibility (including collecting data on narcotics and rescue medications and adverse events), fidelity (whether the intervention was delivered as planned) and acceptability metrics (patients and staff), pain (numeric rating scale), physical function (Short Musculoskeletal Function Assessment questionnaire [SMFA], PROMIS), emotional function (PTSD [PTSD Checklist], depression [Center for Epidemiologic Study of Depression]), and intervention targets (pain catastrophizing, pain anxiety, coping, and mindfulness). Assessments occurred at baseline, 4 and 12 weeks., Results: Several outcomes exceeded a priori benchmarks: feasibility of recruitment (89% [210 of 235] of eligible participants consented), appropriateness (TOR: 73% [66 of 90] scored > midpoint on the Credibility and Expectancy Scale), data collection (79% [154 of 195] completed all surveys), satisfaction (TOR: 99% [75 of 76] > midpoint on the Client Satisfaction Scale), and acceptability (TOR: 73% [71 of 97] attended all four sessions). Participation in TOR, compared with the MEUC, was associated with improvement from baseline to postintervention and from baseline to follow-up in physical function (SMFA, baseline to post: -7 [95% CI -11 to -4]; p < 0.001; baseline to follow-up: -6 [95% CI -11 to -1]; p = 0.02), PROMIS (PROMIS-PF, baseline to follow-up: 2 [95% CI 0 to 4]; p = 0.045), pain at rest (baseline to post: -1.2 [95% CI -1.7 to -0.6]; p < 0.001; baseline to follow-up: -1 [95% CI -1.7 to -0.3]; p = 0.003), activity (baseline to post: -0.7 [95% CI -1.3 to -0.1]; p = 0.03; baseline to follow-up: -0.8 [95% CI -1.6 to -0.1]; p = 0.04), depressive symptoms (baseline to post: -6 [95% CI -9 to -3]; p < 0.001; baseline to follow-up: -5 [95% CI -9 to -2]; p < 0.002), and posttraumatic symptoms (baseline to post: -4 [95% CI -7 to 0]; p = 0.03; baseline to follow-up: -5 [95% CI -9 to -1]; p = 0.01). Improvements were generally clinically important and sustained or continued through the 3 months of follow-up (that is, above the minimum clinically important different [MCID] of 7 for the SMFA, the MCID of 3.6 for PROMIS, the MCID of 2 for pain at rest and pain during activity, the MCID of more than 10% change in depressive symptoms, and the MCID of 10 for posttraumatic symptoms). There were treatment-dependent improvements in pain catastrophizing, pain anxiety, coping, and mindfulness., Conclusion: TOR was feasible and potentially efficacious in preventing persistent pain among patients with an acute orthopaedic traumatic injury. Using TOR in clinical practice may prevent persistent pain after orthopaedic traumatic injury., Level of Evidence: Level I, therapeutic study., Competing Interests: All ICMJE Conflict of Interest Forms for authors and Clinical Orthopaedics and Related Research® editors and board members are on file with the publication and can be viewed on request., (Copyright © 2024 by the Association of Bone and Joint Surgeons.)

Objective: There is increasing recognition that health systems need to measure and improve the value of patient care by measuring outcomes. Chronic pelvic pain secondary to pelvic venous insufficiency can have a significant impact on the quality of life (QOL) of women affected. Despite growing recognition, pelvic venous disorders (PeVDs), an important cause of chronic pelvic pain, remain underdiagnosed. Developing a core outcome set (COS) for benchmarking care delivery enhances the standardization of care. However, there is no consensus regarding a standardized minimum set of outcomes for PeVD. We aimed to generate a list of outcomes reported in previous PeVD treatment studies to lay the foundation for developing a COS for PeVD., Methods: This scoping review was undertaken according to the PRISMA-ScR guidelines. Initially, screening, full-text review and extraction was conducted on studies published between 2018 and 2023. Subsequently, the search was expanded using 1-year intervals, until, over a 1-year interval, no new outcomes were recorded. Closely related outcomes were classified into domains, and domains into three core areas: disease-specific, treatment-related, and QOL-related outcomes., Results: Of the 1579 records identified, 51 publications were included. From these studies, 108 different outcomes were identified. The median number of outcomes per study was 8 (interquartile range, 6-13). Closely related outcomes were organized into 42 outcome domains, which were then categorized into 3 core outcome areas; 47.6% (20/42) were disease specific, 35.7% (15/42) treatment related, and 16.7% (7/42) were QOL related. Of the 51 included studies, disease-specific outcomes were identified in 96.1% of the studies (49/51), treatment-related outcomes in 94.1% (48/51), and QOL outcomes in only 13.7% (7/51)., Conclusions: There was significant heterogeneity in outcomes reported in PeVD studies. Most PeVD treatment studies evaluated disease-specific and treatment-related outcomes of PeVD, but few reported outcomes that measured the impact on QOL. These findings will inform the next steps in developing a COS for PeVD., Competing Interests: Disclosures None., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background: The efficacy of various supervision methods for stabilization exercises in patients with chronic low back pain (CLBP) remains uncertain., Objective: To evaluate the impact of supervised and unsupervised stabilization exercises in patients with CLBP., Methods: Sixty-six participants were assigned to the in-person-supervised, tele-supervised, or unsupervised groups. All participants received a 20-30-minute exercise program three times a week for 4 weeks. We assessed functionality (Oswestry Disability Index), pain intensity (Numeric Rating Scale), and kinesiophobia (Tampa Scale of Kinesiophobia) before and after the 4 weeks. The outcomes were analyzed using effect size, minimum clinically important difference (MCID), minimal detectable change (MDC), Wilcoxon test, and post hoc analyses., Results: While the unsupervised group improved in all measures ( p  < .05) both the tele-supervised ( p  = .001) and in-person-supervised ( p  < .001) groups achieved superior functionality exceeding MDC. The in-person-supervised group demonstrated greater functionality ( p  < .001) than the tele-supervised group, exceeding MCID. Pain intensity decreased in the tele-supervised ( p  = .011) and in-person-supervised groups ( p  < .001) compared to the unsupervised group, exceeding MCID and MDC. No significant difference was found in post-treatment NRS score changes between the supervised groups ( p  = .071). The in-person-supervised group displayed a greater reduction in kinesiophobia than the tele-supervised ( p  < .001) and unsupervised groups ( p  < .001) but not exceeding MCID or MDC. Effect sizes were large within and between groups except for a small effect size between the tele-supervised and unsupervised groups in kinesiophobia., Conclusion: While tele-supervised stabilization exercises alleviate pain and enhance functionality, in-person-supervised exercises may be more effective in improving functionality and reducing kinesiophobia in patients with CLBP.

Objective: Informed by Minority Stress Theory, to investigate disparities in pain intensity, interference, and care in patients with spinal cord injuries (SCI) based on demographic features., Design: Cross-sectional survey., Setting: Outpatient SCI clinics in 2 academic medical centers in the northwestern United States., Participants: Sample of 242 SCI clinic patients who endorsed SCI-related pain, were ≥18-years-of-age, English-fluent, not diagnosed with bipolar or psychotic disorders, and able to make their own medical decisions. Participants were 74.8% men, an average of 48.5 years (range 18.1-89.8 years), 76.2% White, 31.9% privately insured, and 64.7% making <$50,000 per year., Interventions: Not applicable., Main Outcome Measures: Exploratory analyses of screening data from a randomized controlled trial for pain treatment. Primary outcomes included pain intensity, pain interference, and the patient report of recommended pain treatments by a medical provider, tried by the patient, or that the patient would be willing to try., Results: More treatments recommended was associated with younger age (ρ=-0.14, 95% confidence interval [CI]: -0.01 to -0.27, P=.03) and private insurance (ρ=-0.15, 95% CI: 0.02-0.27, P=.03), whereas more treatments tried was associated with private insurance alone (ρ=0.20, 95% CI: 0.07-0.32, P=.003). Number of treatments willing to be tried was associated with lower income (ρ=-0.15, 95% CI: -0.02 to -0.28, P=.03). SCI patients of color (PoC) reported higher pain intensity (Cohen's d=0.41, 95% CI: 0.11-0.71) and greater odds of receiving psychotherapy for pain (odds ratio: 7.12, 95% CI: 1.25-40.46) than their White peers., Conclusions: These exploratory findings indicate differences in SCI-related pain intensity based on identifying as PoC, and differences in SCI-related pain treatment modalities based on identifying as PoC, age, insurance type, and income. Further work exploring differences in SCI-related pain care based on patient social identities is warranted., (Published by Elsevier Inc.)

Background: Despite physical activity being a major component of managing chronic low back pain, < 50% of patients receive physical activity interventions. Electronic Health Records can deepen our understanding about this clinical gap., Objective: We aimed to: 1) develop and test a data abstraction form that captures physical activity documentation; and 2) explore physical therapists' documentation of physical activity assessments and interventions., Methods: We developed a data abstraction form using previously published practice guidelines. After identifying the forms' inter-rater reliability, we used it to explore physical therapists' documentation related to physical activity assessments and interventions for patients with chronic low back pain., Results: The final data abstraction form included information about physical activity history, assessments, interventions, general movement discussion, and plan. Our inter-rater reliability was high. Of the 18 patients, 66.7% had documentation about their PA history. Across the 56 encounters, 14 (25.0%) included an assessment, 18 (32.1%) an intervention, 18 (32.1%) a general movement discussion, and 12 (21.4%) included a plan., Conclusion: Using our reliable data abstraction form we identified a lack of documentation about physical activity assessments and interventions among patients with chronic low back pain. A larger study is needed to examine the generalizability of these results.

The importance of gender is undertheorized in chronic pain research, meaning extant research cannot sufficiently shed light on how chronic pain experience and treatment are connected to institutions and societal structures. Much literature on gender and pain is not critical in orientation, making it difficult to translate data into recommendations for improved treatment and care. Our study takes a critical approach informed by social theory to understand chronic pain among women who experience socioeconomic marginalization. Drawing on a gender-based subanalysis of interview data collected in Canada as part of an institutional ethnography of chronic pain among people who are socioeconomically marginalized, from women's narratives, we identified 4 themes that speak to gender, chronic pain, and marginalization. These are 1) gendered minimization of women's health concerns, 2) managing intergenerational poverty, 3) living with violence and trauma, and 4) gendered organization of family care. Together, these themes highlight how women's experiences of chronic pain and marginalization amplify gendered vulnerabilities in health care, social services, and society in general. Our findings depict a deeply gendered experience of chronic pain that is inseparable from the daily struggle of managing one's life with pain with heavy responsibilities, the baggage of past trauma, and responsibility for others with few resources. We emphasize the importance of chronic pain care and health and social services that are both gender- and trauma-informed. PERSPECTIVE: This article draws on an institutional ethnography (a holistic qualitative methodology) of chronic pain and socioeconomic marginalization to demonstrate the importance of chronic pain care and health and social services that are both gender- and trauma-informed., (Crown Copyright © 2024. Published by Elsevier Inc. All rights reserved.)

Background: Differential target multiplexed spinal cord stimulation (DTM SCS) was shown to be superior to conventional SCS for treating chronic low back pain (CLBP) in subjects with persistent spinal pain syndrome with previous spinal surgery (PSPS-T2) or ineligible for it (PSPS-T1). This study reports 24-month efficacy and safety of DTM SCS vs. conventional medical management (CMM) in PSPS-T1 subjects across four European countries., Methods: This is a prospective, multicenter, open-label, randomized, controlled trial with optional crossover. Subjects randomized 1:1 to DTM SCS or CMM. Primary endpoint was responder rate (% subjects reporting ≥50% CLBP relief) at 6 months. A superiority test compared responder rates between treatments. CLBP and leg pain levels, functional disability, quality of life (QoL), patient satisfaction and global impression of change were evaluated for 24 months. A Composite Responder Index (CRI) was obtained using CLBP relief, disability and QoL. Incidence of study-related adverse events evaluated safety., Results: A total of 55 and 57 subjects were randomized to DTM SCS and CMM respectively. DTM SCS was superior, with CLBP responder rates ≥80% and CLBP relief >5.6 cm (>70% reduction) through the 24-month follow-up. Improvements with DTM SCS in other outcomes were sustained. The CRI was >80% for DTM SCS through 24 months. Opioid medication intake decreased in subjects treated with DTM SCS. Most patients treated with DTM SCS felt satisfied and improved at the end of the study. Safety was congruent with other studies., Conclusion: DTM SCS is efficacious and safe during 24 months for the treatment of CLBP and leg pain in PSPS-T1 patients ineligible for spine surgery., Significance Statement: This randomized controlled trial shows that Differential Target Multiplexed SCS (DTM SCS) is an effective and safe long-term treatment for PSPS type 1 patients suffering from axial low back pain with or without leg pain and who are ineligible for spinal surgery. Currently, CMM treatments are their only option and provide limited benefits. Besides superior pain relief, DTM SCS provides significant improvements in functional disability, quality of life, high levels of satisfaction and perceived impression of change., (© 2024 The Author(s). European Journal of Pain published by John Wiley & Sons Ltd on behalf of European Pain Federation ‐ EFIC ®.)

Background: Occupational health, grounded in occupational medicine, aims to enhance the well-being and labor productivity of the working population. Within this realm, there has been growing concern over the increasing instances of labor loss due to diminished physical capacity and the rise in musculoskeletal disorders. Chronic pain is also associated with musculoskeletal disorders. Another pressing issue related to chronic musculoskeletal pain was needed assistance services are underutilized, is referred to as a "service gap". Understanding trends based on age and affected regions of the body is indispensable for developing strategies to address chronic musculoskeletal pain in workers. This study aimed to elucidate age-specific trends in the prevalence and number of pain sites in chronic musculoskeletal pain as well as the patterns of treatment during chronic musculoskeletal pain, categorized by age and affected site., Methods: This study was conducted in December 2022 in contract to Cross Marketing Inc. The survey began on December 12, 2022 and ended on December 15, 2022. An online survey was administered to 1,946 participants (973 women and 973 men), and responses were collected, ensuring a roughly equal distribution of samples among men and women across six age groups ranging from their 20 to 70 s. The survey inquired about the presence of chronic pain in each of the eight body parts and the adoption of five different treatments when experiencing pain. Statistical analysis was performed using the chi-square test, with the measurement data categorized by age group and body part., Results: The results indicated a significantly higher prevalence of chronic pain at three or more sites among individuals in their 30 s: the prevalence of pain at each of the eight body sites varied with age. Approximately half of the participants did not engage in specific treatments during episodes of chronic pain. The presence or absence of treatment showed no significant differences according to affected site or age group. This study revealed age- and body part-related relationships with chronic musculoskeletal pain in middle-aged patients and highlighted healthcare service gaps in its management in Japan., Competing Interests: The authors declare that they have no competing interests. None of the authors are employees of Cross Marketing, Inc. Yasumasa Oka is an employee of the Kanazawa Orthopedic and Sports Medicine Clinic. Noriyuki Kida is an employee of the Kyoto Institute of Technology. Michio Wachi and Takumi Jiroumaru is an employee of the Bukkyo University., (© 2024 Oka et al.)

Background: Integrating spiritual aspects into treatment plans can release essential resources for coping with chronic pain. However, some spiritual aspects may also induce distress and hinder the coping process. There is a lack of evidence regarding how to perform the clinical tasks of exploring spiritual aspects and of instruments assessing related competencies. Therefore, we developed a web-based learning module to provide education on the subject alongside corresponding assessment instruments. The module presents the InSpiRe (Integration of Spirituality and/or Religion in patient encounters) protocol. The instruments encompass cognitive, affective, and behavioral dimensions., Methods: This paper aims to determine (i) the learning effects associated with completing the web-based spiritual-care learning module and (ii) the reliability and validity of the instruments employed. To address these aims, we conducted a pre-test/post-test trial with N = 32 randomly selected fourth-year medical students. During the pre-test, we assessed the students' knowledge, attitudes, and self-efficacy regarding exploring spiritual aspects. For this purpose, we developed a short-answer knowledge test, an attitude questionnaire, and a self-efficacy scale. Additionally, the students explored spiritual aspects with a simulated patient portraying a person with chronic pain. Three trained raters evaluated the students' performances using a self-developed scale. In the intervention phase, the students completed the 45-minute learning module on a personal computer. The module presented InSpiRe-related content as text and step-by-step video demonstrations, including hints that denote critical actions. The subsequent post-test was identical to the pre-test., Results: The internal consistency was suitable for all respective instruments, and there was an indication of solid validity of the performance test. After completing the spiritual care learning module, the students showed statistically significant increases in knowledge scores and significant positive shifts in their attitudes and levels of self-efficacy regarding exploring spiritual aspects. They also attained significantly higher performance scores in the same regard., Conclusions: Completing the spiritual-care module is associated with meaningful learning effects on cognitive, affective, and behavioral dimensions related to exploring spiritual aspects, as demonstrated in the post-test conducted shortly after the intervention. Due to good reliability and validity scores, the self-developed instruments can be applied appropriately., (© 2024. The Author(s).)

Background: Although psychological interventions can be used to improve chronic pain management, underserved individuals (i.e., racially minoritized and socioeconomically disadvantaged) may be less likely to engage in such services. The purpose of this study was to examine whether offering a psychological intervention for chronic pain in a primary care clinic could be a method in which to successfully engage underserved patients., Methods: There were 220 patients with chronic pain in a primary care clinic located in a socioeconomically and racially diverse city who were approached to discuss enrolment in a pilot randomized controlled trial of a five-session psychological intervention for chronic pain. Patients were introduced to the study by their primary care provider using the warm handoff model. We compared whether there were sociodemographic differences between those who enrolled in the study and those who declined to enrol., Results: There were no differences between those who enrolled and those who declined enrolment with regard to race, age, insurance type, and household income. However, females were more likely to enrol in the study compared to males., Conclusions: Recruiting patients to participate in a trial of a psychological intervention for chronic pain in a primary care clinic appeared to be effective for engaging Black patients, patients with lower income, and those with government insurance. Thus, offering a psychological intervention for chronic pain in a primary care clinic may encourage engagement among racially minoritized individuals and those with lower socioeconomic status.

Objectives: To compare the clinical efficacy between trigger-point (TrP) electroacupuncture and transversus abdominis plane (TAP) block in treatment of chronic abdominal wall pain (CAWP)., Methods: A total of 62 CAWP patients were randomly divided into a TrP electroacupuncture group (31 cases, 1 case dropped off) and a TAP block group (31 cases, 1 case dropped off). Electroacupuncture at trigger points was delivered in the TrP electroacupuncture group, and TAP block was administered under ultrasonic guidance in the TAP block group. Separately, the score of the numerical pain rating scale (NRS) was observed before treatment and in 1 week, 1 month and 3 months after treatment；the scores of the self-rating anxiety scale (SAS) and the self-rating depressive scale (SDS) observed before treatment and in 1 week and 3 months after treatment；and the score of the short form 36 questionnaire (SF-36) was observed before treatment and in 3 months after treatment. The utilization rate of remedial drugs was recorded during follow-up visit. The clinical efficacy was compared., Results: At each time point after treatment, NRS score decreased in comparison with that before treatment ( P <0.05), the scores of SAS and SDS 1 week and 3 months after treatment were reduced ( P <0.05) and the each item score of SF-36 increased ( P <0.05) 3 months after treatment of each group. Compared with the outcomes in the TAP block group, NRS scores were reduced 1 month and 3 months after treatment respectively ( P <0.05), the scores of SAS and SDS decreased ( P <0.05) and SF-36 score was elevated ( P <0.05) 3 months after treatment in the TrP electroacupuncture group. There was no significant difference in the utilization rate of remedial drugs between the two groups. The clinical efficacy of the TrP electroacupuncture group (96.7%) was superior to that of the TAP block group (83.3%, P <0.05)., Conclusions: Both TrP electroacupuncture and TAP block can markedly relieve pain, attenuate the emotional symptoms of anxiety and depression and improve the quality of life in the patients with chronic abdominal wall pain. The clinical efficacy of TrP electroacupuncture is better than that of TAP block 3 months after treatment.

Background and Objective: Non-specific chronic low back pain (NSCLBP) is a prevalent condition causing significant disability and functional impairment. Whole-body vibration exercise (WBVE) has emerged as a new treatment method, but additional research is necessary to determine the optimal parameters of WBVE that would be beneficial for patients experiencing chronic low back pain (CLBP). This study aims to investigate the effects of two type of WBVE (constant vs progressive) on pain, disability, functional performance, and muscle activity in patients with NSCLBP., Methods: Thirty-two individuals diagnosed with chronic low back pain (CLBP) without any specific causes were enrolled and randomly assigned to one of two intervention groups: a constant/fixed protocol WBVE group or a progressive protocol WBVE group. Participants underwent WBVE sessions for around 30 min, thrice weekly over a period of 8 weeks. Primary outcomes assessed included pain intensity, functional disability, functional performance, and electromyographic activity of core musculature, measured at baseline and upon completion of the intervention period. Temporal changes of each outcome variable across different periods and between groups were measured with repeated measures 2×2 mixed ANOVA. Further, the paired t -test was performed to compare pre- and post-treatment values within each group., Results: Significant improvements were observed in both the constant and progressive WBVE protocol groups. Pain intensity decreased by 64.2% ( p  < 0.001) in the constant group and by 61.1% ( p  < 0.001) in the progressive group. Functional disability decreased by 48.1% ( p  < 0.001) in the constant group and by 53.3% ( p  < 0.001) in the progressive group. Functional performance improved by 16.5% ( p  < 0.001) in the constant group and by 16.9% ( p  < 0.001) in the progressive group. Electromyography (EMG) demonstrated significant improvements across all measured variables except % maximum voluntary isometric contraction (%MVIC) of external obliques (EO) in both intervention groups with time ( p  < 0.001). There was no statistically significant difference in the magnitude of improvement between the constant and progressive WBVE protocols ( p  > 0.05), indicating both modalities' effectiveness in ameliorating CLBP symptoms and associated functional impairments., Conclusion: The study demonstrates that both progressive and constant WBVE protocols are equally effective in reducing pain and disability in NSCLBP patients. These findings support the inclusion of progressive WBVE in clinical practice, offering a flexible treatment option that can be tailored to individual patient needs, ensuring both tolerability and effectiveness. This contributes valuable evidence towards optimizing WBVE protocols for managing NSCLBP., Competing Interests: The authors declare there are no competing interests., (©Zafar 2024 et al.)

Objective: People commonly cope with chronic low back pain (cLBP) by ignoring and distraction. Can mindful interoceptive exposure to the pain sensation itself and its phenomenological components be an alternative approach?, Methods: Single-arm feasibility study in patients with cLBP using a 2-minute attention exercise guided by a smartphone app several times per day over 8 weeks. We assessed feasibility, pre/post pain, function, and psychological parameters using mixed methods: standard questionnaires, ecological momentary assessment, and exit interviews that included micro-phenomenology technique and subsequent reflexive thematic qualitative analysis., Results: We enrolled 31 participants, mostly female, mean age 48, the majority had pain for >5 years; 29 completed. Mean pain intensity [0-10] improved from 4.8 ±1.7 to 3.1 ±1.9 (p < .0001); mean PEG scores (intensity and interference with daily life; range 0-30) improved from 13.7 ±6.2 to 8.4 ±6.6 (p < .0001); pain impact (9 items incl physical function) 22.3 ±8.7 to 19.7 ±8.1 (p = .0010). Twenty-one of 29 improved PEG score ≥30%. There were significant improvements in PCS Rumination and MAIA Not-Worrying. Participants became aware of their usual habit of avoidance and the challenge of and resistance to focusing on pain. They were surprised how pain sensations varied over time, and that pain intensity and the threat value of pain could diminish by focusing on it. They described a variety of 3D pain shapes (e.g., football, pool ball, rod, nail, brick, stars) with a range of colors, transparency, temperature, and density that for some changed with mindful attention. Most struggled to find appropriate words for sensory awareness and attention regulation and found that the threat value of their pain diminished., Conclusions: Mindful interoceptive exposure to the sensations of their cLBP using a 2-minute attention exercise with a phone app-rather than ignoring and distracting from it-may be a beneficial intervention for cLBP., Trial Registration: ClinicalTrials.gov #NCT06186193., Competing Interests: Research reported in this publication was supported by the National Institute Of Arthritis And Musculoskeletal And Skin Diseases of the National Institutes of Health under Award Number U19AR076737. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The Back Pain Consortium (BACPAC) Research Program is administered by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)., (Copyright: This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication.)

Objectives: To assess the efficacy of a single intradiscal injection of allogeneic bone marrow mesenchymal stromal cells (BM-MSCs) versus a sham placebo in patients with chronic low back pain (LBP)., Methods: Participants were randomised in a prospective, double-blind, controlled study to receive either sham injection or intradiscal injection of 20 million allogeneic BM-MSC, between April 2018 and December 2022. The first co-primary endpoint was the rate of responders defined by improvement of the Visual Analogue Scale (VAS) for pain of at least 20% and 20 mm, or improvement of the Oswestry Disability Index (ODI) of 20% between baseline and month 12. The secondary structural co-primary endpoint was assessed by the disc fluid content measured by quantitative MRI T2, between baseline and month 12. Secondary endpoints included pain VAS, ODI, the Short Form (SF)-36 and the minimal clinically important difference in all timepoints (1, 3, 6, 12 and 24 months). We determined the immune response associated with allogeneic cell injection between baseline and 6 months. Serious adverse events (SAEs) were recorded., Results: 114 patients were randomised (n=58, BM-MSC group; n=56, sham placebo group). At 12 months, the primary outcome was not reached (74% in the BM-MSC group vs 69% in the placebo group; p=0.77). The groups did not differ in all secondary outcomes. No SAE related to the intervention occurred., Conclusions: While our study did not conclusively demonstrate the efficacy of allogeneic BM-MSCs for LBP, the procedure was safe. Long-term outcomes of MSC therapy for LBP are still being studied., Trial Registration Number: EudraCT 2017-002092-25/ClinicalTrials.gov: NCT03737461., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ on behalf of EULAR.)

Chronic low back pain (LBP) is a common musculoskeletal disorder and is often accompanied by functional leg length inequality (FLLI). However, little was known about the effects of gluteal muscle control training in patients with LBP and FLLI. This study was designed to investigate the effects of gluteal control training in patients with LBP and FLLI. This is a double-blinded, randomized controlled study design. Forty-eight LBP patients with FLLI were randomized to the gluteal control training (GT) (47.58 ± 9.42 years) or the regular training (RT) (47.38 ± 11.31 years) group and received allocated training for six weeks. The outcome measures were pelvic inclination (PI), ilium anterior tilt difference (IATD), FLLI, visual analogue scale (VAS), patient specific-functional scale (PSFS), Oswestry disability index (ODI), hip control ability, global rating of change scale (GRoC), and lower extremity strength and flexibility. The intervention effects were compared using two-way repeated measures analysis of variance and chi-square tests with α = 0.05. The results indicated that the GT group showed greater improvement (P < 0.01) in PI (1.03 ± 0.38∘ vs. 1.57 ± 0.51∘), IATD (0.68 ± 0.66∘ vs. 2.31 ± 0.66∘), FLLI (0.3 ± 0.22 vs. 0.59 ± 0.13 cm), VAS (1.41 ± 1.32 vs. 3.38 ± 1.51), hip control ability (2.20 ± 0.45 vs. 0.89 ± 0.74), GRoC at 3rd and 6th week as compared to the RT group. Hip strength and flexibility also improved more in the GT group (P < 0.05). In conclusion, gluteal control training was more effective in improving low back pain and dysfunctions, and should be integrated in the management plan in patients with LBP and FLLI., (© 2024. The Author(s).)

Background: Nonpharmacological interventions for veterans are needed to help them manage chronic pain and posttraumatic stress disorder (PTSD) symptoms. Complementary and integrative health (CIH) interventions such as Mission Reconnect (MR) seek to provide veterans with the option of a partnered, self-directed intervention that teaches CIH skills remotely to support symptom management., Objective: The purpose of this study was to describe the physical, psychological, and social outcomes of a self-directed mobile- and web-based CIH intervention for veterans with comorbid chronic pain and PTSD and their partners and qualitatively examine their MR user experience., Methods: A sample of veteran-partner dyads (n=364) were recruited to participate in a mixed methods multisite waitlist control randomized controlled trial to measure physical, psychological, and social outcomes, with pain as the primary outcome and PTSD, depression, stress, sleep, quality of life, and relationships as secondary outcomes. Linear mixed models were constructed for primary and secondary patient-reported outcomes. The quantitative analysis was triangulated using qualitative interviews from a subsample of dyads (n=35) to examine participants' perceptions of their program experience., Results: Dyads were randomized to 2 groups: intervention (MR; 140/364, 38.5%) and waitlist control (136/364, 37.4%). No significant change was observed in overall pain, sleep, PTSD, quality of life, relationship satisfaction, overall self-compassion, or compassion for others. A significant reduction in pain interference in mood (P=.008) and sleep (P=.008) was observed among the veteran MR group that was not observed in the waitlist control group. We also observed a positive effect of the MR intervention on a reduction in negative affect associated with pain (P=.049), but this effect did not exceed the adjusted significance threshold (P=.01). Significant improvements were also observed for partners in the affection (P=.007) and conflict (P=.001) subdomains of the consensus and satisfaction domains. In contrast to quantitative results, qualitative data indicated that intervention impacts included improved sleep and reduced pain, anxiety, and stress and, in contrast to the survey data, overall improvement in PTSD symptoms and social relationships. Participants' overall impressions of MR highlight usability and navigation, perceptions on packaging and content, and barriers to and facilitators of MR use., Conclusions: Adjunctive CIH-based modalities can be delivered using web and mobile apps but should be developed and tailored using established best practices. MR may be beneficial for veterans with pain and PTSD and their partners. Further pragmatic trials and implementation efforts are warranted., Trial Registration: ClinicalTrials.gov NCT03593772; https://clinicaltrials.gov/study/NCT03593772., International Registered Report Identifier (irrid): RR2-10.2196/13666., (©Jolie N Haun, Christopher A Fowler, Hari H Venkatachalam, Amy C Alman, Lisa M Ballistrea, Tali Schneider, Rachel C Benzinger, Christine Melillo, Neil B Alexander, S Angel Klanchar, William A Lapcevic, Matthew J Bair, Stephanie L Taylor, Jennifer L Murphy, Dustin D French. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 18.10.2024.)

Advances in closed-loop neural interfaces and neuromodulation have offered a potentially effective and non-addictive treatment for chronic pain. These interfaces link neural sensors with device outputs to provide temporally precise stimulation. We discuss challenges and trends of state-of-the-art neural interfaces for treating pain in animal models and human pilot trials., Competing Interests: Declaration of interests J.W. is a cofounder and scientific advisor for Pallas Technologies, Inc., and Z.S.C. is a scientific advisor of Pallas Technologies, Inc. J.W. and Z.S.C. are inventors of a pending US patent application of pain treatment technology., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Chronic pain affects the quality of life for millions of people worldwide. There is a bidirectional link between pain and sleep: poor sleep quality exacerbates pain, and pain disrupts sleep. Addressing this cycle is crucial for effective pain management and improving patients' overall health outcomes., Competing Interests: Declaration of interests The authors declare that the research was conducted without commercial or financial relationships that could create a conflict of interest., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)