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Background: Obsessive-compulsive disorder (OCD) is a prevalent and burdensome mental health condition, often resistant to conventional treatments. Agomelatine (Valdoxan), a compound acting on serotonin and melatonin systems, has shown promise in treating those with treatment-resistant OCD based on anecdotal reports and case studies. Methods: A randomized, double-blind controlled trial was conducted with 60 patients diagnosed with treatment-resistant OCD. Participants were randomized into an intervention group (receiving agomelatine 50 mg/day) and a control group (receiving placebo). OCD symptoms were assessed using the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) over a 12-week period. Results: There were no significant differences in age, gender, or baseline Y-BOCS scores between intervention and control groups. Agomelatine did not demonstrate a significant improvement in OCD symptoms compared to placebo. Adverse events were comparable between groups, and liver enzyme levels remained within the normal range. Conclusion: This study, while not confirming superior efficacy compared to placebo, underscores the need for continued investigation into agomelatine's potential for treating specific subgroups of OCD patients, underscoring the need for more comprehensive and well-controlled trials in the future. [ABSTRACT FROM AUTHOR]

Background: It is necessary to better understand the structural characteristics of the supraspinatus tendon and associated muscle after rotator cuff repair and in the event of retear. Purpose: To study structural differences between the repaired and contralateral shoulders 1 year after rotator cuff repair in patients who received either progressive exercise therapy (PR) or usual care (UC) in a randomized controlled trial and to investigate whether there was interaction with tendon retear and limb dominance. Study Design: Cohort study; Level of evidence, 2. Methods: Patients with surgically repaired traumatic full-thickness rotator cuff tears involving the supraspinatus tendon were included. After surgery, they were randomized to PR or UC (active from postoperative week 2 or 6, respectively). The subacromial structures (acromiohumeral distance, supraspinatus tendon thickness, and vascularity) and the supraspinatus muscle thickness were examined with ultrasound at the 1-year follow-up. Results: A total of 79 patients were included. The characteristics of the 2 intervention groups (PR and UC) were comparable, including the Western Ontario Rotator Cuff Index score and number of retears. The authors found significantly thinner supraspinatus tendon (PR, P <.001; UC, P =.003) and reduced acromiohumeral distance (PR, P =.023; UC, P =.025) in the repaired versus the contralateral shoulders in both intervention groups. For neovascularization, there was no interlimb difference in either of the groups or between groups (PR vs UC). In patients with intact tendons, there was no interlimb difference in the muscle thickness, but in patients with tendon retear the muscle was significantly thinner on the repaired side (P =.024 and P <.001, respectively). When the dominant supraspinatus tendon was repaired (both groups), it was significantly thinner than the nondominant healthy tendon, but this difference was not seen when the nondominant supraspinatus tendon was repaired (P =.006). Conclusion: One year after rotator cuff surgery, the repaired supraspinatus tendon was significantly thinner and the corresponding acromiohumeral distance was reduced. In patients with retear, the supraspinatus muscle was significantly thinner on the repaired side and early initiation of tendon-loading exercises did not affect these findings. Registration: NCT02969135 (ClinicalTrials.gov identifier). [ABSTRACT FROM AUTHOR]

Purpose: Depressive symptoms are prevalent among Chinese adolescents. However, there is a lack of effective prevention programs to reduce depressive symptoms. Methods: A pilot cluster randomized controlled trial was implemented in a sample of senior secondary school adolescents. Participants in the intervention group (N = 148) received a 6-week universal prevention course, whereas the control group (N = 131) received a routine course focusing on career development. Results: The linear mixed models showed that the group × time interaction was significant for depressive symptoms measured by DASS-21 (F (2, 550) = 5.72, p =.003) and marginally significant for that measured by SMFQ (F (2, 549) = 2.41, p =.09). Likewise, the level of anxiety and stress were significantly reduced after the program, but not maintained in the follow-up. Conclusions: This pilot study showed that a universal prevention program is promising in reducing adolescent depressive symptoms. [ABSTRACT FROM AUTHOR]

Chinese immigrant survivors of men's violence experience both significant mental health impacts from abuse and barriers to formal services. Therefore, we examined the preliminary efficacy of an innovative mobile-based empowerment-based intervention (self-compassion, health, and empowerment; SHE) that specifically focuses on abused Chinese immigrant women in the US. This pilot study used a two-arm randomized controlled design with repeated measures. A convenience sample (N = 50) of Chinese immigrant women who experienced past year intimate partner violence (IPV) were recruited online and randomly assigned to the intervention or control group (25 per group). We assessed IPV exposure, safety behaviors, depressive symptoms, anxiety symptoms, post-traumatic stress disorder (PTSD) symptoms, and self-compassion at baseline, post-intervention, and 8-week follow-up. Of 95 eligible participants, 50 (52.6%) agreed to participate and completed baseline data collection; intervention completion rate was 64%. We found a significant group and time interaction for self-judgment (a self-compassion component), with a significant reduction seen in the intervention group compared to the control group. Despite no other significant group differences observed over time, the intervention group showed consistent trends toward improvements in most outcome measures, including specific types of IPV (i.e., negotiation, psychological aggression, and sexual coercion), depressive and PTSD symptoms, self-compassion, and certain components of self-compassion (i.e., isolation and over-identification) when compared to the control group. Our findings suggest that the SHE intervention shows promise in improving the mental health well-being of Chinese immigrant survivors. However, a fully powered randomized controlled trial is warranted to determine its efficacy. Our intervention has the potential to be translated in the Chinese immigrant populations with the necessary organizational support. [ABSTRACT FROM AUTHOR]

Background: Cannabidiol (CBD) has been shown recently to positively affect patient pain and satisfaction immediately after arthroscopic rotator cuff repair (ARCR). However, it is unclear whether the addition of CBD to a perioperative regimen could affect postoperative outcomes. Purpose: To evaluate patient-reported outcomes among patients who underwent ARCR and received buccally absorbed CBD or an identical placebo for early postoperative pain management at 1-year follow-up. Study Design: Randomized controlled trial; Level of evidence, 2. Methods: Eligible patients had previously participated in a multicenter, placebo-controlled, randomized, double-blinded trial that evaluated the analgesic effects of CBD in the immediate postoperative period after ARCR. The experimental group received 25 mg of CBD 3 times/day if <80 kg and 50 mg of CBD 3 times/day if >80 kg for 14 days, with the control group receiving an identical placebo. The following outcomes were assessed at minimum 1-year follow-up: visual analog scale (VAS) for pain, American Shoulder and Elbow Surgeons (ASES) score, Single Assessment Numeric Evaluation (SANE), and patient satisfaction. The rates of achievement of the Patient Acceptable Symptom State (PASS) were compared based on ASES at latest follow-up. Continuous and categorical variables were compared with the Mann-Whitney U test and Fisher exact test, respectively. Results: Follow-up was obtained from 83 of 99 patients (83.8%) who completed the original trial. There were no significant differences between the CBD and control groups with respect to age, sex, body mass index, rate of concomitant procedures, or number of anchors used intraoperatively. At 1-year follow-up, there were no significant differences between the CBD and control groups in VAS pain (0.8 vs 1.2, P =.38), ASES (93.0 vs 91.1, P =.71), SANE (87.6 vs 90.1, P =.24), or satisfaction (97.4 vs 95.4, P =.41). A majority of patients achieved the PASS (81.0% [CBD] vs 77.5% [control]; P =.79). Conclusion: Perioperative use of CBD for pain control among patients undergoing ARCR did not result in any significant deficits in pain, satisfaction, or patient-reported outcomes at 1-year postoperatively compared with a placebo control group. These findings suggest that CBD can be considered in a postoperative multimodal pain management regimen without detrimental effects on outcome. Registration: NCT04672252 (ClinicalTrials.gov identifier). [ABSTRACT FROM AUTHOR]

This study sought to evaluate the impact of the subcutaneous tunneling technique on peripherally inserted central catheter (PICC) placement. We randomized 694 patients who needed PICC placement to either the tunneled PICCs (experimental group) or the non-tunneled PICCs (control group) from August to December 2021. The cumulative frequency of complications was assessed as the primary outcome. Secondary outcomes comprised of the amount of bleeding, catheter insertion time, self-reported pain score, and one-puncture success rate. After 6 months of follow-up, the tunneled PICCs group showed a significant decrease in the frequency of total complications, especially in infection (3.0% vs. 7.1%, p =.021) and catheter-related thrombosis (3.3% vs. 8.3%, p =.008), although approximately 0.5 ml bleeding and 3.5 min time were increased. This randomized multicenter study supports the efficacy of subcutaneous tunneling technology in reducing PICC-related complications, enhancing patient comfort, and encouraging using subcutaneous tunneling technology for PICC placement. [ABSTRACT FROM AUTHOR]

Background: Randomized controlled trials (RCTs) are crucial in comparative research, and a careful approach to randomization methodology helps minimize bias. However, confounding variables like socioeconomic status (SES) and race are often underreported in orthopaedic RCTs, potentially affecting the generalizability of results. This study aimed to analyze the reporting trends of SES and race in RCTs pertaining to Achilles tendon pathology, considering 4 decades of data from top-tier orthopaedic journals. Methods: This review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and used PubMed to search 10 high-impact factor orthopaedic journals for RCTs related to the management of Achilles tendon pathology. The search encompassed all articles from the inception of each journal until July 11, 2023. Data extraction included year of publication, study type, reporting of SES and race, primary study location, and intervention details. Results: Of the 88 RCTs identified, 68 met the inclusion criteria. Based on decade of publication, 6 articles (8.8%) reported on SES, whereas only 2 articles (2.9%) reported on race. No RCTs reported SES in the pre-1999 period, but the frequency of reporting increased in subsequent decades. Meanwhile, all RCTs reporting race were published in the current decade (2020-2030), with a frequency of 20%. When considering the study location, RCTs conducted outside the United States were more likely to report SES compared with those within the USA. Conclusion: This review revealed a concerning underreporting of SES and race in Achilles tendon pathology RCTs. The reporting percentage remains low for both SES and race, indicating a need for comprehensive reporting practices in orthopaedic research. Understanding the impact of SES and race on treatment outcomes is critical for informed clinical decision making and ensuring equitable patient care. Future studies should prioritize the inclusion of these variables to enhance the generalizability and validity of RCT results. [ABSTRACT FROM AUTHOR]

Background: Industry funding and corporate sponsorship have played a significant role in the advancement of orthopaedic research and technology. However, this relationship raises concerns for how industry association may bias research findings and influence clinical practice. Purpose: To determine whether industry affiliation plays a role in the outcomes of randomized controlled trials (RCTs) investigating platelet-rich plasma (PRP). Study Design: Meta-analysis; Level of evidence, 2. Methods: A search of the PubMed, Cochrane, and MEDLINE databases for RCTs published between 2011 and the present comparing PRP versus hyaluronic acid, corticosteroid, or placebo for the treatment of knee osteoarthritis was performed. To determine industry affiliation, the conflict of interest, funding, and disclosure sections of publications were assessed, and all authors were assessed through the American Academy of Orthopaedic Surgeons disclosure database and the Centers for Medicare & Medicaid Services open payments database. Studies were classified as industry affiliated (IA) or non–industry affiliated (NIA). The outcomes of each study were rated as favorable, analogous, or unfavorable according to predefined criteria. Results: A total of 37 studies (6 IA and 31 NIA) were available for analysis. Overall, 19 studies (51.4%) reported PRP as favorable compared with other treatment options, while 18 studies (48.6%) showed no significant differences between PRP and other treatment methods. There was no significant difference in qualitative conclusions between the IA and NIA groups, with the IA group having 3 favorable studies and 3 analogous studies and the NIA group having 16 favorable studies and 15 analogous studies (P =.8881). When comparing IA versus NIA studies using 6- and 12-month Western Ontario and McMaster Universities Arthritis Index and International Knee Documentation Committee scores, there were no significant differences in outcomes. Conclusion: The results of this study demonstrated that qualitative conclusions and outcome scores were found to not be associated with industry affiliation. Although the results of this study suggest that there is no influence of industry involvement on RCTs examining PRP, it is still necessary to carefully evaluate pertinent commercial affiliations when reviewing recommendations from studies before adopting new treatment approaches, such as the use of PRP for knee osteoarthritis. [ABSTRACT FROM AUTHOR]

Background: Oxaliplatin-based chemotherapy is a major first-line conventional therapy for advanced and metastatic colorectal cancer (CRC). However, oxaliplatin causes chemotherapy-induced peripheral neuropathy (CIPN). Acupuncture has long been used to alleviate limb numbness in Chinese medicine practice. Aim: The aim of this study was to examine the efficacy and safety of electroacupuncture (EA) for the alleviation of CIPN in CRC patients. Design: This was a pilot single-blinded, randomized, sham-controlled trial. Setting/participants: Sixty eligible patients, who had been diagnosed with CRC and were undergoing oxaliplatin-based chemotherapy, were randomized in a ratio of 1:1 to the EA intervention group or sham acupuncture (SA) control group. During a 12-week treatment period, patients in the EA group received EA once a week, while patients in the SA group received SA; both groups were followed up for 12 weeks. Results: Compared with the SA group, the EA group exhibited significant alleviation of CIPN severity during chemotherapy. Moreover, EA also improved the physical function, role function, and social function of CRC patients. However, there were no significant differences in tests of vibration or light touch sensation. In addition, EA appeared to be a safe treatment for CIPN and was both feasible and acceptable to CRC patients during chemotherapy. Conclusion: This study showed preliminary evidence for the efficacy and safety of EA in acute CIPN among CRC patients, although further studies are needed to verify these effects and to further explore the potential role of EA in chronic CIPN (effects on which remain unclear). Trial registration number: NCT03582423 (ClinicalTrials.gov) [ABSTRACT FROM AUTHOR]

Background: Many Gulf War (GW) Veterans report chronic symptoms including pain, fatigue, and cognitive impairment, commonly defined as Gulf War Illness (GWI). Complementary and integrative health (CIH) therapies may potentially improve multiple symptoms of GWI. Objective: To examine the effectiveness of combining 2 commonly available CIH therapies, mindfulness meditation and auricular acupuncture, in improving health-related functioning and multiple symptom domains of GWI (e.g., pain, fatigue). Methods: This study was a randomized controlled trial in which Veterans with GWI were randomly assigned to either the intervention group (n = 75), wherein they received 2 distinct CIH therapies – mindfulness meditation and auricular acupuncture, or the active control group, wherein they received a GW Health Education (GWHE) program (n = 74), each lasting 8 weeks. Self-report health measures were assessed at baseline, endpoint, and 3 month follow-up. Results: In the intention-to-treat analyses, there were significant between-group differences for mental-health related functioning, fatigue, depression symptoms, and Kansas total severity scores for symptoms in which the CIH group had improved scores for these outcomes at endpoint compared to the GWHE group (all P ≤.05). The CIH group also had significant reductions in pain interference at endpoint and follow-up compared to baseline (estimated marginal mean difference: −2.52 and −2.22, respectively; all P =.01), whereas no significant changes were observed in the GWHE group. For pain characteristics, the GWHE group had a worsening of pain at endpoint compared to baseline (estimated marginal mean difference: +2.83; P =.01), while no change was observed in the CIH group. Conclusion: Findings suggest a possible beneficial effect of combining 2 CIH therapies, mindfulness meditation and auricular acupuncture, in reducing overall symptom severity and individual symptom domains of fatigue, musculoskeletal, and mood/cognition in Veterans with GWI. Trial Registration: Clinical Trials identifier NCT02180243 [ABSTRACT FROM AUTHOR]

Background: People aging with long-term physical disabilities are living longer and experiencing the challenges of aging, including the onset of secondary and age-related health conditions. People aging with long-term physical disabilities are at high risk of falls, fall injuries, diminished functional abilities, and compromised participation. However, no available programs support people aging with long-term physical disabilities to participate safely at home and in the community. The proposed study is to examine the feasibility and efficacy of an adapted intervention: removing environmental barriers to independent living. Method/Design: A single-blinded randomized controlled trial will be conducted. Participants who are 45–65 years old; self-report difficulty with ⩾2 daily activities; have had a physical disability for ⩾5 years; and live within 60 mi of the research lab are eligible. All participants will receive an initial in-home evaluation before randomization. The treatment group will receive removing environmental barriers to independent living (total five visits) intervention, which is tailored. The waitlist control group will be offered the same intervention after 6-month follow-up. Expected outcomes are high acceptability, fidelity, and adherence; low safety risk; improved community participation and daily activities performance; and fewer environmental barriers and fall hazards. Discussion: Findings will serve as preliminary evidence for occupational therapy community practice. Outcomes will also inform future large, pragmatic trials. Trial Registration: ClinicalTrials.gov identifier NCT04589988 [ABSTRACT FROM AUTHOR]

Children with low performance in early numeracy are at risk of facing learning difficulties in mathematics, but few trials have examined how this can be ameliorated. A total of 120 first-grade children (Mage = 6.4 years) were randomly assigned to an intervention or a control condition. The 14-week intervention targeted early numeracy skills and was delivered in small groups three times a week. Immediately after the initial 8-week intervention phase, moderate and positive effects were found on early numeracy (d = 0.19), word problem solving (d = 0.41), and approximate number sense (d = 0.35). However, only the effects on word problems were significant, and all effects disappeared after the children undertook a second 6-week intervention phase. Overall, results indicate that (a) early numeracy skills are malleable in low-performing children, but (b) frequent and long-term interventions are needed for the positive effects to last. [ABSTRACT FROM AUTHOR]

Background: Scalp acupuncture has been found to be effective at improving motor function after ischemic stroke, but few studies examining its central mechanisms of action have been carried out. The aim of this study was to investigate the clinical effects of scalp acupuncture on motor dysfunction and changes in spontaneous brain activity in patients with ischemic stroke. Methods: This was an evaluator- and analyst-blinded, multi-center randomized controlled trial. A total of 108 convalescent-stage ischemic stroke patients with motor dysfunction were allocated to receive either scalp acupuncture combined with rehabilitation treatment (SR group) or rehabilitation treatment alone (RE group). Patients in both groups received treatment 5 times per week for 8 weeks. The primary outcome measure was the Fugl-Meyer assessment (FMA). Secondary outcome measures included the modified Barthel index (mBI), modified Rankin scale (mRS) and values of fractional amplitude of low frequency fluctuation (fALFF) acquired using a resting-state functional magnetic resonance imaging (rs-fMRI) technique. Results: Both groups showed significant improvements in motor function, daily life ability and degree of disability, as measured by FMA, mRS and mBI (p < 0.05), and the SR group showed a significantly greater improvement (p < 0.05). Compared with the RE group, the areas where the fALFF values increased in the SR group were located in the cerebellum, praecuneus, precentral gyrus, superior frontal gyrus and parietal lobe. The improvement in FMA scores had the strongest correlation with the baseline fALFF values of the ipsilateral precentral gyrus. Conclusion: Scalp acupuncture improved motor function in convalescent-period ischemic stroke patients, and effects were correlated with regulation of motor-relevant brain regions. The fALFF value of the ipsilateral precentral and postcentral gyri could be potential clinical indices for prognostication of motor dysfunction. Trial registration number: NCT03120650 (http://www.clinicaltrials.gov). [ABSTRACT FROM AUTHOR]

Background: The evidence available on the association between social support and prevention of depression has been basically obtained from observational studies. Aim: We evaluated the effectiveness of social support-based interventions for the prevention of depression in people without clinical depression. Methods: Systematic review and meta-analysis (SR/MA) of randomized controlled trials (RCT), which were searched for in MEDLINE, EMBASE, CENTRAL, WOS, PsycINFO, OpenGrey and other sources from the inception dates to June 8, 2022. We selected RCTs that assessed the effectiveness of social support-based interventions as compared to controls, included subjects without baseline clinical depression, and measured as results a reduction in depressive symptoms and/or the incidence of new cases of depression. Pooled standardized mean differences (SMDs) were calculated from random effects models. Results: Nine RCTs involving 927 patients from North America, Asia and Europe were included. The pooled SMD was −0.43 [95% confidence interval (CI) −0.82 to −0.04; p =.031]. Sensitivity analyses confirmed the robustness of results. Heterogeneity was substantial [ I 2 = 80% (95% CI: 64% to 89%)]. A meta-regression model that included usual care as comparator and the continent (Europe), explained 53% of heterogeneity. Eight RCTs had a moderate overall risk of bias and one had a high risk of bias. Follow-up was ⩾1 year in only three RCTs. There was no statistical evidence of publication bias. The quality of evidence, as measured on GRADE guidelines, was low. Conclusion: Social support-based interventions had a small preventive effect on depression. Longer RCTs with a low risk of bias are necessary. [ABSTRACT FROM AUTHOR]

RE-AIM is an implementation science framework that provides a structure to promote data collection and analysis in the domains of R each, E fficacy/ E ffectiveness, A doption, I mplementation, and M aintenance. The RE-AIM approach promotes more data collection and reporting than typical evaluations so potential adopters can determine the potential program fit for their setting. RE-AIM has been used to evaluate a variety of programs; however, there are few resources that provide strategies for conducting a RE-AIM evaluation in the school setting. The purpose of this article is to inform future studies by elucidating experiences conducting a large, complex, multisite, longitudinal RE-AIM evaluation in schools in partnership with the state's Departments of Education and Health, and to share strategies for overcoming obstacles. With the long-term goal of facilitating the translation of school-based intervention research into practice, we provide key considerations and recommend strategies for school-based RE-AIM evaluation success. [ABSTRACT FROM AUTHOR]

Objective: To test the feasibility of a telephone delivered intervention, informed by cognitive behavioural principles, for post-stroke fatigue, and estimated its effect on fatigue and other outcomes. Design: Randomised controlled parallel group trial. Setting: Three Scottish stroke services. Subjects: Stroke survivors with fatigue three months to two years post-stroke onset. Interventions: Seven telephone calls (fortnightly then a 'booster session' at 16 weeks) of a manualised intervention, plus information about fatigue, versus information only. Main measures: Feasibility of trial methods, and collected outcome measures (fatigue, mood, anxiety, social participation, quality of life, return to work) just before randomisation, at the end of treatment (four months after randomisation) and at six months after randomisation. Results: Between October 2018 and January 2020, we invited 886 stroke survivors to participate in postal screening: 188/886 (21%) returned questionnaires and consented, of whom 76/188 (40%) were eligible and returned baseline forms; 64/76 (84%) returned six month follow-up questionnaires. Of the 39 allocated the intervention, 23 (59%) attended at least four sessions. At six months, there were no significant differences between the groups (adjusted mean differences in Fatigue Assessment Scale −0.619 (95% CI −4.9631, 3.694; p = 0.768), the Generalised Anxiety Disorder 7 −0.178 (95% CI −3.823, 3.467, p = 0.92), and the Patient Health Questionnaire −0.247 (95% CI −2.935, 2.442, p = 0.851). There were no between-group differences in quality of life, social participation or return to work. Conclusion: Patients can be recruited to a trial of this design. These data will inform the design of further trials in post-stroke fatigue. [ABSTRACT FROM AUTHOR]

Objective: Specification of interventions and selection of controls are two methodological determinants for a successful acupuncture trial. However, current practice with respect to these two determinants is not fully understood. Thus, we conducted a cross-sectional survey to examine the specification of interventions and selection of controls among published randomized controlled trials (RCTs) of acupuncture. Study design and setting: We searched PubMed for acupuncture RCTs published in core clinical journals and complementary and alternative medicine (CAM) journals from January 2010 to December 2019 (10 years) and included RCTs that assessed treatment effects of acupuncture versus any type of control. We used network meta-analyses to explore whether there were differential treatment effects in patients with chronic pain when using sham acupuncture as a control versus using waiting list or no treatment. Results: Most of the 319 eligible RCTs specified well the style of acupuncture (86.8%), traditional acupuncture point locations (96.2%), type of needle stimulation (90.3%) and needle retention time (85.6%). However, other acupuncture details were less-frequently specified, including response sought (65.5%), needle manipulation (50.5%), number of needle insertions (21.9%), angle and direction of insertion (31.3%), patient posture (32.3%) and co-interventions (22.9%). Sham acupuncture (41.4%) was the most frequently used control, followed by waiting list or no treatment (32.9%). There was no differential treatment effect when using sham acupuncture versus waiting list/no treatment as a control (standardized mean difference = −0.15, 95% confidence interval: −0.91 to 0.62). Conclusion: Over a decade of research practice, important gaps have remained in the specification of acupuncture interventions, including response sought, needle manipulation, and co-interventions. While sham acupuncture has been widely used, waiting list or no treatment may also be considered as an appropriate control. [ABSTRACT FROM AUTHOR]

The current study aimed to explore the impact of a school-based mindfulness intervention on bullying behaviors among teenagers. A cluster randomized controlled trial was conducted, in which the experimental group (n = 92) received mindfulness intervention, and the control group (n = 97) did not. The measured outcomes included: bullying behavior, self-control, and trait mindfulness. The results were as follows: (1) the post-test scores of trait mindfulness and self-control in the experimental group significantly increased (p < 0.01) while the scores of bullying behavior significantly decreased (p < 0.01); (2) trait mindfulness was positively associated with self-control (r = 0.13 to 0.63, p < 0.05), whereas trait mindfulness and self-control were both negatively associated with bullying behavior (r = −0.38 to −0.13, p < 0.05); and (3) the mediating effect of self-control accounted for 50% of the overall effect of trait mindfulness on bullying behavior. These findings demonstrated that the school-based mindfulness intervention distinctly improves trait mindfulness and self-control and reduces bullying behavior among teenagers. Moreover, self-control plays a mediating role between trait mindfulness and bullying behavior. [ABSTRACT FROM AUTHOR]

Objective: The objective of this study is to evaluate the efficacy and safety of electroacupuncture (EA) treatment for post-stroke depression (PSD). Methods: This study was a single-center, single-blinded, parallel-arm randomized controlled trial. In total, 65 patients with PSD were randomly allocated into EA and sham EA groups. Treatment was administered at GV20, Sishencong, SP6, LR3 and BL18 in both groups. The EA group received EA treatment, while the sham EA group received sham EA treatment using the Park device. Treatment was given three times a week for 4 weeks. The primary outcome was the Hamilton Rating Scale for Depression (HRSD). Secondary outcomes included the Zung Self-Rating Depression Scale (SDS), National Institutes of Health Stroke Scale (NIHSS), Barthel Daily Living Index (BI) and depression scale of traditional Chinese medicine (TCM). Primary and secondary outcomes were assessed at baseline, week 2 after treatment, week 4 after treatment and week 8 of follow-up. Safety assessment was conducted at each visit for 4 weeks of treatment. Results: Significant differences in HRSD, SDS, NIHSS, BI and TCM scale scores were found in the EA group before and after acupuncture treatment (all p < 0.001). Compared with the sham EA group, HRSD scores improved significantly in the EA group at the end of week 2 (F = 31.33, p < 0.001), week 4 (F = 35.58, p < 0.001) and week 8 after treatment onset (F = 25.03, p < 0.001). Similarly, significant improvements were observed in SDS, NIHSS and BI scores. Two participants in the EA group suffered a local hematoma, while no adverse events were reported in the sham EA group. Conclusion: EA appears to be an efficacious and safe treatment for PSD. According to our results, EA may alleviate depressive symptoms, and improve neurological function and capabilities with respect to activities of daily living (ADLs). Trial registration number: ChiCTR-IOR-17012610 (Chinese Clinical Trial Registry). [ABSTRACT FROM AUTHOR]

Despite increased prevalence of domestic violence and abuse (DVA), victimization through DVA often remains undetected in mental health care. To estimate the effectiveness of a system provider level training intervention by comparing the detection and referral rates of DVA of intervention community mental health (CMH) teams with rates in control CMH teams. We also aimed to determine whether improvements in knowledge, skills and attitudes to DVA were greater in clinicians working in intervention CMH teams than those working in control teams. We conducted a cluster randomized controlled trial in two urban areas of the Netherlands. Detection and referral rates were assessed at baseline and at 6 and 12 months after the start of the intervention. DVA knowledge, skills and attitudes were assessed using a survey at baseline and at 6 and 12 months after start of the intervention. Electronic patient files were used to identify detected and referred cases of DVA. Outcomes were compared between the intervention and control teams using a generalized linear mixed model. During the 12-month follow-up, detection and referral rates did not differ between the intervention and control teams. However, improvements in knowledge, skills and attitude during that follow-up period were greater in intervention teams than in control teams: β 3.21 (95% CI 1.18-4.60). Our trial showed that a training program on DVA knowledge and skills in CMH teams can increase knowledge and attitude towards DVA. However, our intervention does not appear to increase the detection or referral rates of DVA in patients with a severe mental illness. A low detection rate of DVA remains a major problem. Interventions with more obligatory elements and a focus on improving communication between CMH teams and DVA services are recommended. [ABSTRACT FROM AUTHOR]

Objectives: To determine if Cognitive Orientation to Occupational Performance was effective in improving performance and transfer of motor learning in children with developmental coordination disorder (with/without attention deficit hyperactivity disorder); and whether outcomes were maintained three months post-intervention. Design: Randomized waitlist-control trial (ClinicalTrials.gov ID: NCT02597751) Setting: BC Children's Hospital, Vancouver, Canada Subjects: Thirty-seven children with developmental coordination disorder and 41 children with co-occurring attention deficit hyperactivity disorder (all 8–12 years), randomized to treatment or waitlist groups. Interventions: One-hour of intervention once weekly for 10 weeks. Main Measures: (1) Canadian Occupational Performance Measure to measure self-perceived performance of motor goals (10-point scale); (2) Performance Quality Rating Scale to measure therapist-observed movement quality (10-point scale); and (3) Bruininks-Oseretsky Test of Motor Proficiency – 2nd ed. to measure overall motor skill ability/transfer of motor learning (percentile). Results: Both groups showed significant improvement (p < 0.001) in motor performance (developmental coordination disorder: pre: 2.7 ± 2.2, post: 7.0 ± 1.0; developmental coordination disorder with attention deficit hyperactivity disorder: pre: 2.3 ± 1.7, post: 7.0 ± 1.5) and movement quality (developmental coordination disorder: pre: 3.0 ± 1.5, post: 6.3 ± 1.7; developmental coordination disorder with attention deficit hyperactivity disorder: pre: 3.0 ± 1.9, post: 5.7 ± 2.3). Three months after treatment, children maintained their gains, but only children with developmental coordination disorder showed transfer of learning to overall motor skills (pre:12 ± 15, post:12 ± 12, follow-up:14 ± 20, p < 0.001). Conclusion: Intervention was similarly effective for children with developmental coordination disorder with/without attention deficit hyperactivity disorder in achieving and maintaining functional motor goals, but only children with developmental coordination disorder showed transfer of learning to other motor skills. [ABSTRACT FROM AUTHOR]

Objective: To study the long-term effectiveness of case-management rehabilitation intervention on vocational reintegration of patients after myocardial infarction (MI). Design: Blinded simple randomization was used to construct an intervention and control groups that were followed up for two years. Subjects and setting: 151 patients, aged 50.3 ± 5.9 years, who experienced uncomplicated MI and were enrolled in a cardiac rehabilitation program were recruited. Interventions: included an early referral to an occupational physician, tailoring an occupational rehabilitation program, based on individual patient needs, coordination with relevant parties, psychosocial intervention, intensive follow-up sessions during a two-year follow-up. Main measures: Return to work within six months of hospitalization and maintenance of employment at one and two years of follow-up. Results: Return-to-work (RTW) rate in the intervention group was 89% and nearly all maintained employment at one year of follow-up (92%) and two years of follow-up (87%). Moreover, almost all of them returned to and maintained their previous jobs. The corresponding figures were: 98%, 94% and 98%, respectively. The figures for the RTW and employment maintenance for the control group were: 74%, 75%, and 72%, respectively. Only about 75%, in this group kept their previous job. The case-management intervention was associated with increased odds of maintaining employment at follow-up of one year (OR = 5.89, 95% CI 1.42–24.30) and two years (OR = 3.12, 95% CI 1.01–10.03). Conclusions: The extended case-management rehabilitation intervention had a substantial positive impact on both the RTW of MI patients and their maintenance of employment at one and two years of follow-up. Trial Registration: This trial is registered at US National Institutes of Health #NCT04934735. [ABSTRACT FROM AUTHOR]

Introduction: In heart transplant recipients, nonadherence is associated with higher risk of morbidity and mortality. Research Question: Can a psychoeducational intervention enhance adherence to medical recommendations? Design: We randomized 200 patients awaiting heart transplantation on the high urgency wait list to a manualized psychoeducational intervention or standard care. Follow-up continued to three years after transplantation. Primary endpoint was adherence to immunosuppressive medication, assessed at 3, 6, 12, 24, and 36 months posttransplant. Secondary endpoints were barriers to adherence during follow-up and clinical outcomes, including cardiac rejection within the first postoperative year and postoperative 3-year mortality. Results: Fifty patients died before or within the first 3 months of transplantation. The primary endpoint was analyzed in 66 patients in the intervention group and 66 in the control group. Both study groups showed almost maximal adherence to immunosuppressive medication throughout follow-up, with no significant time x treatment interaction (P>0.99). Likewise, there was no significant time x treatment interaction (P =0.41) on barriers to adherence. The percentage of patients with International Society for Heart and Lung Transplantation standard grade 1 and 2 rejection was in the intervention and control groups 82.5% and 78.7%, respectively, and 8.8% and 13.1%, respectively, without significant differences between study groups (P =0.75). Considering all randomized and transplanted patients in the intervention group (N=85) and control group (N=87), postoperative 3-year mortality was 29.4% and 27.6%, respectively (P =0.82). Conclusions: Adherence to immunosuppressive medication was high, even without a complex, manualized psychoeducational intervention. The intervention had no significant positive impact on cardiac rejection and mortality. [ABSTRACT FROM AUTHOR]

Objective: To determine the clinical effectiveness of adding virtual reality via the Nintendo Wii console and its Wii Balance Board to physiotherapy treatment in patients with total hip arthroplasty. Design: Randomized controlled trial. Setting: Clinical Hospital San Borja Arriaran, Santiago, Chile. Participants: A total of 73 patients over 50 years of age with total hip arthroplasty were randomly allocated to two groups. Interventions: The control group (n = 37) received 6 weeks of physiotherapy treatment; the intervention group (n = 36) received the same treatment plus virtual reality exercises with the Nintendo Wii console. Outcome measures: The two groups were assessed at baseline and after the 6 weeks of treatment. The primary outcome assessed was the function with the WOMAC questionnaire. The secondary outcomes were the Berg Balance Scale, distance covered with the six-minute walk test, and difference in weight load on the lower extremities. Results: A total of 73 patients, 37 patients in the control group (20 women; mean age of 70.9 ± 9.16 years) and 36 patients in the intervention group (18 women; mean age of 70.39 ± 9.02 years) were analyzed. At the end of the treatment, the difference between groups for the total WOMAC score was −10.4 points (p = 0.00), 4.7 points (p = 0.00) for the Berg Balance Scale, and 45.2 mt (p = 0.00) for the six-minute walk test All differences were in favor of the intervention group. Conclusions: In the short term, the addition of virtual reality via the Nintendo Wii and its Wii Balance Board platform showed statistically significant differences in the function of patients with total hip replacement, but these differences were not minimally clinically important. Trial registration : This research was registered in the Clinical Trials Registry of Australia and New Zealand, with reference ACTRN12618001252202. [ABSTRACT FROM AUTHOR]

Background: Autologous microfragmented lipoaspirate tissue has been recently introduced in orthopaedics as an easily available source of nonexpanded adipose-derived mesenchymal stem cells. Autologous microfragmented lipoaspirate tissue is expected to create a suitable microenvironment for tendon repair and regeneration. Rotator cuff tears show a high incidence of rerupture and represent an ideal target for nonexpanded mesenchymal stem cells. Purpose: To evaluate the safety and efficacy of autologous lipoaspirate tissue in arthroscopic rotator cuff repair. Study Design: Randomized controlled trial; Level of evidence, 2. Methods: Consecutive patients referring to the investigation center for surgical treatment of magnetic resonance imaging–confirmed degenerative posterosuperior rotator cuff tears were assessed for eligibility. Those who were included were randomized to receive a single-row arthroscopic rotator cuff repair, followed by intraoperative injection of autologous microfragmented adipose tissue processed with an enzyme-free technology (treatment group) or not (control group). Clinical follow-up was conducted at 3, 6, 12, 18, and 24 months; at 18 months after surgery, magnetic resonance imaging of the operated shoulder was obtained to assess tendon integrity and rerupture rate. Results: An overall 177 patients were screened, and 44 (22 per group) completed the 24-month follow-up. A statistically significant difference in favor of the treatment group in terms of Constant-Murley score emerged at the primary endpoint at 6-month follow-up (mean ± SD; control group, 76.66 ± 10.77 points; treatment group, 82.78 ± 7.00 points; P =.0050). No significant differences in clinical outcome measures were encountered at any of the other follow-up points. No significant differences emerged between the groups in terms of rerupture rate, complication rate, and number of adverse events. Conclusion: This prospective randomized controlled trial demonstrated that the intraoperative injection of autologous microfragmented adipose tissue is safe and effective in improving short-term clinical and functional results after single-row arthroscopic rotator cuff repair. Registration: NCT02783352 (ClinicalTrials.gov identifier). [ABSTRACT FROM AUTHOR]

Objective: To compare the effectiveness of two different exercise-based programs through telerehabilitation in patients with coronavirus disease 2019. Design: Randomized, controlled, parallel, double-blinded, three-arm clinical trial. Setting: Patients' homes through telerehabilitation devices. Subjects: Subjects with coronavirus disease 2019 in the acute phase. Interventions: Subjects were divided into three groups: breathing exercises group, strength exercises group or no treatment/control group. Main measures: We analysed visual analogue scale for fatigue, 6-minute walking test, 30-seconds sit-to-stand test, multidimensional dyspnoea-12 questionnaire and Borg scale at baseline and 14 days later. Results: From 93 subjects recruited, 88 were enrolled, and 77 patients (mean [SD] age 39.40 [11.71]) completed the 14-days intervention and were included in the analysis: 26 in strength exercises group, 29 in breathing exercises group and 22 in control group. The intergroup analysis shows significant differences between the study groups and control group in all variables (p < 0.05); Borg scale, multidimensional dyspnoea-12 questionnaire (pre–post intervention score: strength exercises group: 7.85 [6.82] – 4.54[4.82], breathing exercises group: 11.04 [6.49] – 5.32 [3.63], control group: 10.27 [6.49] – 10.59[6.58]), visual analogue scale for fatigue, 6-minute walking test and 30-seconds sit-to-stand test (pre–post intervention score: strength exercises group: 12.19 [4.42] – 13.58 [5.37], breathing exercises group: 11.18 [3.42] – 12.79 [4.00], control group: 10.45 [2.15] – 9.86[1.88]). The greatest effect sizes were found in the variables Borg Scale (R 2 = 0.548) and multidimensional dyspnoea-12 questionnaire (R 2 = 0.475). Conclusions: Strength exercises group and breathing exercises group obtained significant improvements in fatigue, dyspnoea, perceived effort, and physical state, compared to control group, although the greatest benefits were found for dyspnoea and aerobic capacity in breathing exercises group. [ABSTRACT FROM AUTHOR]

Background: Chronic Achilles and patellar tendinopathy are a significant burden in physically active populations. High-volume image-guided injection (HVIGI) proposes to strip away associated neovascularity, disrupt painful nerve ingrowth, and facilitate rehabilitation. Purpose: To investigate the efficacy of HVIGI with and without steroid relative to placebo. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: A total of 62 participants were recruited between May 25, 2016, and March 5, 2020. Participants were men aged 18 to 55 years with Achilles or patellar tendinopathy of at least 6-month chronicity that had not improved with nonoperative management (including physical therapy and shockwave therapy), with ultrasound evidence of neovascularization, tendon thickening, and echogenic changes. They were assigned to the following groups: control (3 mL of subcutaneous 0.5% bupivacaine), HVIGI (10 mL of 0.5% bupivacaine and 30 mL of normal saline, ultrasound-guided between tendon and underlying fat pad), or HVIGI with steroid (HVIGIwSteroid; 0.25 mL of 100 mg/mL hydrocortisone). Clinicians and assessors were blinded. All participants were supervised through a pain-guided progressive loading program for 6 months postinjection. The main outcome measures were the Victoria Institute of Sport Assessments (VISA) for Achilles and patellar tendinopathy and the visual analog scale (VAS) for pain at 6 months postinjection. Results: The VISA score improved by a mean of 22.8 points (95% CI, 10.4-35.3 points; effect size [ES], 1.51) in the control group (n = 21), 18.6 points (95% CI, 9.1-28.0 points; ES, 1.31) in the HVIGI group (n = 21), and 18.5 points (95% CI, 3.4-33.6 points; ES, 0.88) in the HVIGIwSteroid group (n = 20). VAS pain improved by a mean of 15 points (interquartile range [IQR], -38.75, 8 points; ES, 0.39) in controls, 13 points (IQR,-34.0, 3.75 points; ES, 0.47) in the HVIGI group, and 27 points (IQR,-38.0, -1.0 points; ES, 0.54) in the HVIGIwSteroid group. The main effects were significant for time (P < .001) but not group (P ≥ .48), with no group x time interaction (P = .71). One participant was lost to follow-up from each group, multiple imputation was used for missing data points. No adverse events occurred. Conclusion: Study findings did not demonstrate superiority of HVIGI over control injection. [ABSTRACT FROM AUTHOR]

Background: Although previous studies have reported good short-term results for superficial medial collateral ligament (sMCL) reconstruction, whether an augmented MCL repair is clinically equivalent remains unclear. Purpose/Hypothesis: The purpose of this study was to compare clinical outcomes between randomized groups that underwent sMCL augmentation repair and sMCL autograft reconstruction. The hypothesis was that there would be no significant differences in objective or subjective outcomes between groups. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Patients were prospectively enrolled between 2013 and 2019 from 3 centers. Grade III sMCL injuries were confirmed via stress radiography. Patients were randomized to anatomic sMCL reconstruction versus augmented repair with surgical treatment, determined after examination under anesthesia confirmed sMCL incompetence. Postoperative visits occurred at 6 weeks and 6 months for repeat evaluation, with repeat stress radiography at final follow-up. Patient-reported outcome measures were obtained pre- and postoperatively at 6 months, 1 year, and final follow-up. The primary outcome measure was side-to-side difference on valgus stress radiographs at a minimum follow-up of 1 year. The two 1-sided t test procedure was used to test clinical equivalence for side-to-side difference in valgus gapping, and the Mann-Whitney U test was used to compare postoperative patient-reported outcome measures between groups. Results: A total of 54 patients were prospectively enrolled into this study. Of these, 50 patients had 6-month stress radiograph data, while 40 had 1-year postoperative valgus stress radiograph data. The mean (SD) patient age was 38.0 years (14.2), and body mass index was 25.0 (3.6). Preoperative valgus stress radiographs demonstrated 3.74 mm (1.1 mm) of increased side-to-side gapping overall, while it was 4.10 mm (1.46 mm) in the MCL augmentation group and 3.42 mm (0.55 mm) in the MCL reconstruction group. Postoperative valgus stress radiographs at an average of 6 months were obtained in 50 patients after surgery, which showed 0.21 mm (0.81 mm) for the MCL augmentation group and 0.19 mm (0.67 mm) for the MCL reconstruction group (P =.940). At final follow-up (minimum 1 year), median (interquartile range) Lysholm scores were significantly higher in the reconstruction group (90 [83-99]) as compared with the repair group (80 [67-92]) (P =.031). Final International Knee Documentation Committee (IKDC) scores were also significantly higher for the reconstruction group (85 [68-89]) versus the repair group (72 [60-78] (P =.039). Postoperative Tegner scores were not significantly different between the repair group (5 [3.5-6]) and the reconstruction group (5.5 [4-7]) (P =.123). Patient satisfaction was also not significantly different between repair (7.5 [5.75-9.25]) and reconstruction groups (9.0 [7-10]) (P =.184). Conclusion: This study found no difference in objective outcomes between an sMCL augmentation repair and a complete sMCL reconstruction at 1 year postoperatively, indicating equivalence between these procedures. Patient-reported clinical outcomes favored the reconstruction over a repair. In addition, this study demonstrated that anatomic-based treatment of MCL tears with an early knee motion program had a very low risk of graft attenuation and a low risk of arthrofibrosis. [ABSTRACT FROM AUTHOR]

Frequent indoor tanning bed use is an established public health concern, yet research on tanning cessation interventions for frequent tanners is lacking. We describe the protocol for a brief, web-based tanning behavior change intervention and present evidence that it is acceptable and engaging to frequent indoor tanners. Lower tanning rates were not observed among participants receiving the intervention in a randomized controlled trial but participants’ interest in changing tanning increased. This intervention could be a useful approach to increasing frequent tanners’ interest in behavior change and openness to engaging within a more intensive, multi-component tanning cessation program. [ABSTRACT FROM AUTHOR]

Objective: Determine efficacy of the novel WiiNWalk intervention on walking-related outcomes in older adults with lower limb amputation. Design: Multi-site, parallel, evaluator-masked randomized controlled trial. Setting: Home-setting in three Canadian cities. Participants: Community-dwelling lower limb prosthesis users over 50 years of age. Interventions: The WiiNWalk group (n = 38) used modified Wii Fit activities for prosthetic rehabilitation. The attention control group (n = 33) used Big Brain Academy: Wii Degree, comprising of cognitive activities. Both groups completed a 4-week supervised phase with three 1-h sessions/week in groups of three overseen by a clinician via videoconferencing and a 4-week unstructured and unsupervised phase. Main Measures: Primary outcome was walking capacity (2 min walk test); secondary outcomes were balance confidence (activities-specific balance confidence scale), dynamic balance (four-step square test), and lower limb functioning (short physical performance battery). Outcomes were compared across time points with repeated measures analysis of covariance, adjusting for baseline and age. Results: Mean age was 65.0 (8.4) years, with 179.5 (223.5) months post-amputation and 80% transtibial amputation. No group difference in a 2 min walk test with an effect size: 1.53 95% CI [−3.17, 6.23] m. Activities balance confidence was greater in the WiiNWalk group by 5.53 [2.53, 8.52]%. No group difference in the four-step square test −0.16 [−1.25, 0.92] s, nor short physical performance battery 0.48 [−0.65, 1.61]. A post-hoc analysis showed the greatest difference in balance confidence immediately after an unsupervised phase. Conclusions: The WiiNWalk intervention improved balance confidence, but not walking-related physical function in older adult lower limb prosthesis users. Future rehabilitation games should be specific to the amputation context. Clinical Trial Registration number, NCT 01942798. [ABSTRACT FROM AUTHOR]

Objective: To examine the effects of the provision of a cane, delivered to ambulatory people with chronic stroke, for improving walking and social participation. Design: Two-arm, randomized trial. Setting: Community-based. Participants: Ambulatory individuals with chronic stroke. Interventions: The experimental intervention was the provision of a single-point cane during one month. The control group received a placebo intervention. Outcome measures: Walking speed, step length, cadence, walking capacity, and walking confidence were measured without the cane to examine its rehabilitative effect. Walking speed was also measured with the cane for inclusiveness, and social participation was measured for examining carry over effects. Outcomes were measured at baseline, and after one and two months. Results: Fifty individuals were included. In the experimental group, mean age was 69 years (SD 14), and walking speed was 0.58 m/s (SD 0.17). In the control group, mean age was 68 years (SD 13), and walking speed was 0.63 m/s (SD 0.15). When walking without the cane, after one and after two months, there were no between-group differences in any measures. When walking with the cane, after one month, the experimental group walked 0.14 m/s (95% CI 0.05–0.23) faster than the control group and after two months, they were still walking 0.18 m/s (95% CI 0.06–0.30) faster. Conclusion: Use of a cane improved walking speed, only when participants walked with the cane. Use of cane for one month did not improve walking outcomes, when walking without the cane. People with stroke would need to continue to use the cane to maintain any benefits in walking speed. [ABSTRACT FROM AUTHOR]

Background: Chronic exertional compartment syndrome (CECS) of the anterior leg compartment (ant-CECS) is frequently treated with a minimally invasive fasciotomy. Several operative techniques and operative devices exist, but none have been compared in a systematic and randomized manner. Purpose: To compare efficacy, safety, and postoperative pain of a novel operative device (FascioMax fasciotome) with a widely accepted device created by Due and Nordstrand (Due fasciotome) during a minimally invasive fasciotomy for ant-CECS. Study Design: Randomized controlled trial; Level of evidence, 2. Methods: Patients with bilateral isolated ant-CECS between October 2013 and April 2018 underwent a minimally invasive fasciotomy using the FascioMax fasciotome in 1 leg and the Due fasciotome in the contralateral leg in a single operative session. Symptom reduction at 3 to 6 months and >1 year, postoperative pain within the first 2 weeks, peri- and postoperative complications, and ability to regain sports were assessed using diaries, physical examination, and timed questionnaires. Results: Included in the study were 50 patients (66% female; median age, 22 years [range, 18-65 years]). No differences between the devices were found in terms of perioperative complications (both had none), minor postoperative complications including hematoma and superficial wound infection (overall complication rate: FascioMax, 8% vs Due, 6%), or reduction of CECS-associated symptoms at rest and during exercise. At long-term follow-up (>1 year), 82% of the patients were able to regain their desired type of sport, and 67% (33/49) were able to exercise at a level that was comparable with or higher than before their CECS-associated symptoms started. Conclusion: Both the FascioMax and the Due performed similarly in terms of efficacy, safety, and levels of pain within the first 2 weeks postoperatively. Registration: NL4274; Netherlands Trial Register. [ABSTRACT FROM AUTHOR]