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BackgroundChronic musculoskeletal pain has a vast global prevalence and economic burden. Conservative therapies are universally recommended but require patient engagement and self-management to be effective. ObjectiveThis study aimed to evaluate the efficacy of a 12-week digital care program (DCP) in a large population of patients with chronic knee and back pain. MethodsA longitudinal observational study was conducted using a remote DCP available through a mobile app. Subjects participated in a 12-week multimodal DCP incorporating education, sensor-guided exercise therapy (ET), and behavioral health support with 1-on-1 remote health coaching. The primary outcome was pain measured by the visual analog scale (VAS). Secondary measures included engagement levels, program completion, program satisfaction, condition-specific pain measures, depression, anxiety, and work productivity. ResultsA total of 10,264 adults with either knee (n=3796) or low back (n=6468) pain for at least three months were included in the study. Participants experienced a 68.45% average improvement in VAS pain between baseline intake and 12 weeks. In all, 73.04% (7497/10,264) participants completed the DCP into the final month. In total, 78.60% (5893/7497) of program completers (7144/10,264, 69.60% of all participants) achieved minimally important change in pain. Furthermore, the number of ET sessions and coaching interactions were both positively associated with improvement in pain, suggesting that the amount of engagement influenced outcomes. Secondary outcomes included a 57.9% and 58.3% decrease in depression and anxiety scores, respectively, and 61.5% improvement in work productivity. Finally, 3 distinct clusters of pain response trajectories were identified, which could be predicted with a mean 76% accuracy using baseline measures. ConclusionsThese results support the efficacy and scalability of a DCP for chronic low back and knee pain in a large, diverse, real-world population. Participants demonstrated high completion and engagement rates and a significant positive relationship between engagement and pain reduction was identified, a finding that has not been previously demonstrated in a DCP. Furthermore, the large sample size allowed for the identification of distinct pain response subgroups, which may prove beneficial in predicting recovery and tailoring future interventions. This is the first longitudinal digital health study to analyze pain outcomes in a sample of this magnitude, and it supports the prospect for DCPs to serve the overwhelming number of musculoskeletal pain sufferers worldwide.

BackgroundClinical assessments for physical function do not objectively quantify routine daily activities. Wearable activity monitors (WAMs) enable objective measurement of daily activities, but it remains unclear how these map to clinically measured physical function measures. ObjectiveThis study aims to derive a representation of physical function from daily measurements of free-living activity obtained through a WAM. In addition, we evaluate our derived measure against objectively measured function using an ordinal classification setup. MethodsWe defined function profiles representing average time spent in a set of pattern classes over consecutive days. We constructed a function profile using minute-level activity data from a WAM available from the Osteoarthritis Initiative. Using the function profile as input, we trained statistical models that classified subjects into quartiles of objective measurements of physical function as measured through the 400-m walk test, 20-m walk test, and 5 times sit-stand test. Furthermore, we evaluated model performance on held-out data. ResultsThe function profile derived from minute-level activity data can accurately predict physical performance as measured through clinical assessments. Using held-out data, the Goodman-Kruskal Gamma statistic obtained in classifying performance values in the first quartile, interquartile range, and the fourth quartile was 0.62, 0.53, and 0.51 for the 400-m walk, 20-m walk, and 5 times sit-stand tests, respectively. ConclusionsFunction profiles accurately represent physical function, as demonstrated by the relationship between the profiles and clinically measured physical performance. The estimation of physical performance through function profiles derived from free-living activity data may enable remote functional monitoring of patients.

ObjectiveBiomechanics represents the common final output through which all biopsychosocial constructs of back pain must pass, making it a rich target for phenotyping. To exploit this feature, several sites within the NIH Back Pain Consortium (BACPAC) have developed biomechanics measurement and phenotyping tools. The overall aims of this article were to: 1) provide a narrative review of biomechanics as a phenotyping tool; 2) describe the diverse array of tools and outcome measures that exist within BACPAC; and 3) highlight how leveraging these technologies with the other data collected within BACPAC could elucidate the relationship between biomechanics and other metrics used to characterize low back pain (LBP).MethodsThe narrative review highlights how biomechanical outcomes can discriminate between those with and without LBP, as well as among levels of severity of LBP. It also addresses how biomechanical outcomes track with functional improvements in LBP. Additionally, we present the clinical use case for biomechanical outcome measures that can be met via emerging technologies.ResultsTo answer the need for measuring biomechanical performance, our "Results" section describes the spectrum of technologies that have been developed and are being used within BACPAC.Conclusion and future directionsThe outcome measures collected by these technologies will be an integral part of longitudinal and cross-sectional studies conducted in BACPAC. Linking these measures with other biopsychosocial data collected within BACPAC increases our potential to use biomechanics as a tool for understanding the mechanisms of LBP, phenotyping unique LBP subgroups, and matching these individuals with an appropriate treatment paradigm.

ObjectiveInvestigate associations between endplate and motion segment magnetic resonance imaging (MRI) characteristics and treatment outcomes following basivertebral nerve radiofrequency ablation (BVN RFA) in patients with clinically suspected vertebral endplate pain (VEP).DesignAggregated cohort study of 296 participants treated with BVN RFA from three prospective clinical trials.MethodsBaseline MRI characteristics were analyzed using stepwise logistic regression to identify factors associated with treatment success. Predictive models used three definitions of treatment success: (1) ≥50% low back pain (LBP) visual analog scale (VAS), (2) ≥15-point Oswestry Disability Index (ODI), and (3) ≥50% VAS or ≥15-point ODI improvements at 3-months post-BVN RFA.ResultsThe presence of lumbar facet joint fluid (odds ratio [OR] 0.586) reduced the odds of BVN RFA treatment success in individuals with clinically suspected VEP. In patients with a less advanced degenerative disc disease (DDD) profile, a > 50% area of the endplate with bone marrow intensity changes (BMIC) was predictive of treatment success (OR 4.689). Both regressions areas under the curve (AUCs) were under 70%, indicating low predictive value. All other vertebral endplate, intervertebral disc, nerve roots facet joint, spinal segmental alignment, neuroforamina, lateral recesses, and central canal MRI characteristics were not associated with BVN RFA success.ConclusionsIn patients with vertebrogenic low back pain with Modic changes, the presence of degenerative findings of the anterior and posterior column was not associated with a clinically important impact on BVN RFA treatment success. None of the models demonstrated strong predictive value, indicating that the use of objective imaging biomarkers (Type 1 and/or 2 Modic changes) and a correlating presentation of pain remain the most useful patient selection factors for BVN RFA.

IntroductionVertebral endplates, innervated by the basivertebral nerve (BVN), are a source of chronic low back pain correlated with Modic changes. A randomized trial comparing BVN ablation to standard care (SC) recently reported results of an interim analysis. Here, we report the results of the full randomized trial, including the 3-month and 6-month between-arm comparisons, 12-month treatment arm results, and 6-month outcomes of BVN ablation in the former SC arm.MethodsProspective, open label, 1:1 randomized controlled trial of BVN ablation versus SC in 23 US sites with follow-up at 6 weeks, 3, 6, 9, and 12 months. SC patients were re-baselined and followed up for 6 months post BVN ablation. The primary endpoint was the between-arm comparison of mean Oswestry Disability Index (ODI) change from baseline. Secondary endpoints were Visual Analog Scale (VAS), Short Form (SF-36), EuroQual Group 5 Dimension 5-Level Quality of Life (EQ-5D-5L), responder rates, and rates of continued opioid use.Results140 were randomized. Results from BVN ablation (n=66) were superior to SC (n=74) at 3 months for the primary endpoint (mean ODI reduction, difference between arms of -20.3 (CI -25.9 to -14.7 points; p

BACKGROUND: The past two decades have witnessed a surge in the use of lumbar facet blocks and radiofrequency ablation (RFA) to treat low back pain (LBP), yet nearly all aspects of the procedures remain controversial. METHODS: After approval by the Board of Directors of the American Society of Regional Anesthesia and Pain Medicine, letters were sent to a dozen pain societies, as well as representatives from the US Departments of Veterans Affairs and Defense. A steering committee was convened to select preliminary questions, which were revised by the full committee. Questions were assigned to 4-5 person modules, who worked with the Subcommittee Lead and Committee Chair on preliminary versions, which were sent to the full committee. We used a modified Delphi method, whereby the questions were sent to the committee en bloc and comments were returned in a non-blinded fashion to the Chair, who incorporated the comments and sent out revised versions until consensus was reached. RESULTS: 17 questions were selected for guideline development, with 100% consensus achieved by committee members on all topics. All societies except for one approved every recommendation, with one society dissenting on two questions (number of blocks and cut-off for a positive block before RFA), but approving the document. Specific questions that were addressed included the value of history and physical examination in selecting patients for blocks, the value of imaging in patient selection, whether conservative treatment should be used before injections, whether imaging is necessary for block performance, the diagnostic and prognostic value of medial branch blocks (MBB) and intra-articular (IA) injections, the effects of sedation and injectate volume on validity, whether facet blocks have therapeutic value, what the ideal cut-off value is for a prognostic block, how many blocks should be performed before RFA, how electrodes should be oriented, the evidence for larger lesions, whether stimulation should be used before RFA, ways to mitigate complications, if different standards should be applied to clinical practice and clinical trials and the evidence for repeating RFA (see table 12 for summary). CONCLUSIONS: Lumbar medial branch RFA may provide benefit to well-selected individuals, with MBB being more predictive than IA injections. More stringent selection criteria are likely to improve denervation outcomes, but at the expense of more false-negatives. Clinical trials should be tailored based on objectives, and selection criteria for some may be more stringent than what is ideal in clinical practice.

Objective: To confirm that the simplified insole does not affect the gait speed and to identify objective sensor-based gait parameters that correlate strongly with existing clinical gait assessment scales. Methods: Ten participants with gait impairment due to hemiplegic stroke were enrolled in this study. Pairs of insoles with four pressure sensors on each side were manufactured and placed in each shoe. Data were extracted during the 10-Meter Walk Test. Several sensor-derived parameters (for example stance time, heel_on-to-toe_peak time, and toe_peak pressure) were calculated and correlated with gait speed and lower extremity Fugl-Meyer (F-M) score. Results: The insole pressure sensor did not affect gait, as indicated by a strong correlation (β=0.988) and high agreement (ICC=0.924) between the gait speeds with and without the insole. The parameters that correlated most strongly with highest β coefficients against the clinical measures were stance time of the non-hemiplegic leg (β=-0.87 with F-M and β=- 0.95 with gait speed) and heel_on-to-toe_peak time of the non-hemiplegic leg (β=-0.86 with F-M and -0.94 with gait speed). Conclusion: Stance time of the non-hemiparetic leg correlates most strongly with clinical measures and can be assessed using a non-obtrusive insole pressure sensor that does not affect gait function. These results suggest that an insole pressure sensor, which is applicable in a home environment, may be useful as a clinical endpoint in post-stroke gait therapy trials. [ABSTRACT FROM AUTHOR]

Background The effectiveness and safety of intraosseous basivertebral nerve ablation (BVNA) for treating vertebrogenic pain is established, but low back pain-related healthcare utilization (LBPr-HU) following BVNA continues to be defined. Methods LBPr-HU data were pooled from 3 prospective studies. LBPr-HU categories of interest included non-invasive conservative care, opioid utilization, lumbosacral spinal injection (LSI), lumbosacral radiofrequency ablation (LRFA), and lumbosacral spinal surgery. Pre- and post-BVNA LBPr-HU were compared at both 1- and 5-years using McNemar's test for proportions and paired t-tests for means. Results Two hundred forty-seven patients received BVNA and had 1-year follow-up; 205 had long-term follow-up (mean of 5.3 ± 1.33 years). Twenty-seven percent fewer participants initiated conservative care in the year post-BVNA compared to the year preceding BVNA (P  < .001; 95% CI 19.8–34.5). Of 77/247 participants taking opioids at baseline, 40.3% and 61.7% fewer were taking them at one-year and 5.3 ± 1.33 years post-BVNA, respectively (P  < .001). Of participants receiving LSIs in the year preceding BVNA, 81.2% fewer received LSI(s) in the year post-BVNA (P  < .001; 95% CI 70.7–90.7); a 76.4% reduction in LSIs was maintained through a mean of 5.3 ± 1.33 years post-BVNA. LRFA rates were 1.6% at 1-year post-BVNA and 8.3% at 5.3 ± 1.33 years post-BVNA. Lumbar fusion surgery was 0.8% at 1-year post-BVNA and 6.5% at 5.3 ± 1.33 years post-BVNA. Conclusions In this aggregate analysis of patients with vertebrogenic pain, utilization of conservative care, opioids, LSIs, and LRFA were substantially reduced through 5 years post-BVNA compared to baseline. Lumbar fusion rates were less than half the published value at 5 years in similar populations. [ABSTRACT FROM AUTHOR]