Assessing the transparency in reporting of clinical trials investigating manual therapy interventions for low back pain: A methodological review.

RATIONALE: Low back pain (LBP) is a common condition with a significant societal burden. Manual therapy is an effective treatment for LBP and recommended in clinical practice guidelines. While the quantity of literature supporting the use of manual therapy is large, the methodological quality and transparency of this collective work are unclear. AIMS AND OBJECTIVES: Explore the transparency in reporting of clinical trials assessing manual therapy interventions in patients with LBP by comparing planned components in the trial registration with what was reported in the published manuscript. METHODS: Three databases were searched to identify trials assessing the treatment effect of manual therapy for LBP from January 2005 to May 2023. Studies were included if the manual therapy consisted of thrust manipulations, mobilizations or muscle energy techniques. RESULTS: From 4462 studies initially identified, 167 studies remained in the final review after title, abstract and full-text review. Only 87 (52.1%) of the 167 studies were registered (n = 57 prospectively and n = 30 retrospectively). Primary outcomes in the publications were identical to the registration in 54 (62.1%) of the registered trials. Secondary outcomes in the publication were identical to the registration in 27 (31.0%) of the registered trials. The CONSORT reporting guideline was referenced in only 19 (21.8%) trials. Multiple discrepancies between registration and publication were noted for primary and secondary outcomes. All trials had eligibility criteria in the registration that matched their corresponding manuscript, while only four (4.6%) trial registrations addressed any type of statistical analysis plan. CONCLUSION: Approximately half of the trials were not registered. Of those registered, only half were registered prospectively. Substantial discrepancies existed between registered and published outcomes that were never addressed by the authors, raising questions about potential bias. Transparency can be improved through more stringent requirements during manuscript submission to journals, and better reporting of the rationale for discrepancies between registration and publication.

Self-acknowledged limitations in exercise therapy trials for low back pain.

RATIONALE: Despite the widespread recommendation to engage in therapeutic exercise for the treatment of low back pain (LBP), there is conflicting evidence regarding clinical outcomes and effectiveness. Poor methodological quality may be to blame for reducing the overall strength of evidence for this intervention, yet little is known about the difficulties researchers encounter when designing and implementing their study methods. AIMS AND OBJECTIVES: The aim of this study was to characterize the extent and type of self-acknowledged limitations (SALs) in exercise therapy trials for LBP to gain a better understanding of challenges encountered when conducting this research. METHODS: This is a methodological review of clinical trials in which SALs were extracted, categorized by theme and subcategorized within each theme. Counts and prevalence rates were tabulated for the number of SALs in each category and subcategory. RESULTS: There were 914 SALs among the 312 included trials, with a mean of 2.93 (95% confidence interval [CI], 2.77-3.09) per trial. Analysis of the data resulted in the development of 13 distinct categories of limitations, among which were 37 subcategories. The top three categories pertained to statistical power (14.3% of total SALs), study length and/or follow-up (14.3%) and inclusion criteria (14.2%). The top three subcategories were lack of long-term follow-up (13.8% of total SALs), inadequate sample size (13.3%) and inclusion of specific populations (12.3%). CONCLUSION: Statistical power, study length and/or follow-up, and inclusion criteria were the three most commonly reported categories of SALs in exercise trials for LBP. Lack of long-term follow-up, inadequate sample size and inclusion of specific populations were the most common subcategories. Research protocols recognizing and avoiding these limitations will enhance the overall quality of evidence of exercise therapy trials for LBP.

Adverse Events Reported in Trials Assessing Manual Therapy to the Extremities: A Systematic Review.

Objective: This review aimed to describe the quality and comprehensiveness of adverse event (AE) reporting in clinical trials incorporating manual therapy (MT) as an intervention for extremity conditions using the Consolidated Standards of Reporting Trials (CONSORT)-Harms extension as the benchmark. The secondary aim was to determine whether the quality of AE reporting improved after the availability of the CONSORT reporting checklist. Design: Systematic review. Methods: A literature search was conducted using multiple databases to identify trials where MT was used to treat extremity conditions. Studies that reported AEs were identified and evaluated using the CONSORT-Harms extension. The frequency of trials reporting study AEs before and after the publication of the updated 2010 CONSORT statement was calculated, along with the categorization of how study AEs were reported. Results: Of the 55,539 studies initially identified, 220 trials met all inclusion criteria. Eighty trials (36.4%) reported AE occurrence. None of the studies that reported AEs adhered to all 10 criteria proposed by the 2010 CONSORT-Harms extension. The most commonly reported criterion was number four, which clarified how AE-related information was collected (30% of trials). The least reported criterion was number six, which describes the participant withdrawals for each arm due to AEs and the experience with the allocated treatment (1.3% of trials). The nomenclature used to describe AEs varied substantially. Fifty-nine of 76 trials (33.3%) were published after the updated CONSORT Harms-checklist was available, compared to 21 of 44 trials (46.7%) published before it was available. Conclusion: Reporting of AEs in trials investigating MT for extremity conditions is poor. Every included trial lacked adherence to all 10 criteria proposed by the CONSORT-Harms Extension. The quality and comprehensiveness of AE reporting did not improve after the most recent CONSORT update recommending AE reporting. Clinicians must obtain informed consent before performing any intervention, including MT, which requires disclosing potential risks, which could be better known with improved tracking, analyzing, and reporting of AEs. The authors recommend improved adherence to best practices for adequately tracking and reporting AEs in future MT trials.

The majority of clinical trials assessing mobilization and manipulation for neck pain lack a pragmatic approach: a systematic review of 174 trials.

BACKGROUND: Disorders of the cervical spine are some of the costliest musculoskeletal conditions to manage globally. Joint mobilization and manipulation have been shown to be an effective treatment for neck pain. However, the generalizability and clinical translation depends on the nature of the trial designs that inform its use. The extent to which randomized control trials (RCTs) assessing manual therapy treatments for cervical spine disorders fall on the efficacy (explanatory) -effectiveness (pragmatic) spectrum often informs how the findings are translated into clinical practice. OBJECTIVE: The aim of this systematic review was to determine where RCTs of manual therapy for neck disorders fall on the efficacy-effectiveness spectrum. METHODS: A search of three electronic databases including PubMed, CINAHL, and CENTRAL were completed for trials published from inception to May 2023. RCTs in which joint mobilization or manipulation were used to treat cervical spine disorders were assessed on the effectiveness-efficacy spectrum using the Rating of Included Trials on the Efficacy-Effectiveness Spectrum (RITES) tool and risk of bias using the Revised Cochrane Risk of Bias tool. RESULTS: A total of 174 trials met eligibility. RITES domain two trial setting (71.3% vs 16.1%), domain three flexibility of intervention(s) (62.1% vs 23%), and domain four clinical relevance of experimental and comparison intervention(s) (51.7% vs 29.3%) all favored efficacy over effectiveness. Domain one participant characteristic(s) had a slightly greater emphasis on effectiveness compared to efficacy (36.8% vs 44.8%). Most studies (96%) had at least some risk of bias. CONCLUSION: Over half of the RCTs assessing the treatment effect of joint mobilization and manipulation for neck pain favor efficacy (explanatory) over effectiveness (pragmatic) designs. Future RCTs on this topic should consider a greater emphasis on pragmatic trial design components in order to better reflect real-world translation to clinical practice.

The influence of exercise therapy dosing on pain and functional outcomes in patients with subacromial pain syndrome: A systematic review.

Background: The objective was to identify exercise therapy dosing parameters for subacromial pain syndrome (SAPS) associated with improved pain and function outcomes (via effect sizes) and determine the extent of exercise intervention reproducibility. Methods: An electronic search of PubMed/MEDLINE, Cumulative Index to Nursing and Allied Health Literature, EMBASE, Cochrane Database of Systematic Reviews, and SportDiscus identified studies that used exercise therapy exclusively to treat SAPS. Exercise therapy dosing parameters were extracted and within-group effect sizes were calculated for all pain and functional outcomes. Template for Intervention Description and Replication and Consensus on Exercise Reporting were used to record intervention reporting. The risk of bias and Grading of Recommendations, Assessment, Development, and Evaluation were assessed by two reviewers. Results: Twenty-one trials with 674 subjects were included. Effect sizes for pain and function were large in 18 studies, medium in six studies, and small or no effect in four studies, despite the type of supervision. With moderate certainty, effect sizes of pain and function were not influenced by exercise therapy dosing parameters. Intervention reporting was generally poor. Discussion: Exercise therapy for SAPS was associated with large effect sizes for improvement in pain and function but optimal exercise therapy dosing parameters could not be identified. Strong recommendations conditionally suggest treating SAPS with a variety of exercise therapy dosing parameters.

Pragmatism in manual therapy trials for knee osteoarthritis: a systematic review.

Introduction: Manual therapy is an often-utilized intervention for the management of knee osteoarthritis (OA). The interpretation of results presented by these trials can be affected by how well the study designs align applicability to real-world clinical settings. Aim: To examine the existing body of clinical trials investigating manual therapy for knee OA to determine where they fall on the efficacy-effectiveness spectrum. Methods: This systematic review has been guided and informed by the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) guidelines. Randomized controlled trials that investigated manual therapy treatments for adults with knee OA were retrieved via searches of multiple databases to identify trials published prior to April 2023. The Rating of Included Trials on the Efficacy-Effectiveness Spectrum (RITES) tool was used to objectively rate the efficacy-effectiveness nature of each trial design. The Cochrane Risk of Bias 2.0 assessment tool (RoB-2) was used to assess the risk of bias across five domains. Results: Of the 36 trials, a higher percentage of trials had a greater emphasis on efficacy within all four domains: participant characteristics (75.0%), trial setting (77.8%), flexibility of intervention (58.3%), and clinical relevance of experimental and comparison intervention (47.2%). In addition, 13.9% of the trials had low risk of bias, 41.7% had high risk of bias, and 44.4% had some concerns regarding bias. Conclusions: While many trials support manual therapy as effective for the management of knee OA, a greater focus on study designs with an emphasis on effectiveness would improve the applicability and generalizability of future trials.

What are patients' perspectives on the value of physical therapy? A prospective cohort study.

PURPOSE: To assess and identify patients' perceptions about the overall value of physical therapy services for musculoskeletal conditions and how these values were associated with their outcomes. METHODS: The association between the perceived value of physical therapy (as a score) and Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference and physical function at 6-weeks was assessed in a prospective cohort. Generalised linear models were used to identify relationships between the value of physical therapy score and PROMIS outcomes. Kendall's tau was used to identify correlations between responses and outcomes. RESULTS: A total of 133 participants met the final inclusion criteria. The majority of participants were female (63.9%) with a mean age of 55.53 (SD 15.36) years. A majority of participants (63.9%) reported a previous positive personal experience with physical therapy. There was no significant relationship between perceived value of physical therapy and pain interference (ß -0.32, p = 0.07, 95% CI-0.67, 0.03) or physical function (ß 0.19, p = 0.29, 95% CI-0.16, 0.54). Stronger beliefs in agreement with the value of non-invasive treatment were significant, but weakly correlated with lower pain interference (r = -0.18, p = 0.048) and higher physical function scores (r = 0.22, p = 0.03). CONCLUSIONS: Participants had an overall positive perception of the value of physical therapy prior to initiating physical therapy, but this perception was not associated with 6-week pain and function outcomes. A better understanding of the driving factors encouraging patients to seek physical therapy services is needed to provide value-based care.

Physical therapy interventions used to treat individuals with biceps tendinopathy: a scoping review.

BACKGROUND: Shoulder pain related to pathology of the long head of the biceps tendon (LHBT) can be debilitating. Chronic LHBT tendinopathy is a common condition that is difficult to treat. Little consensus exists regarding the optimal approach to treating individuals with LHBT tendinopathy. OBJECTIVE: To systematically scope the literature to identify and present the available information regarding physical therapist interventions used for the management of individuals with LHBT tendinopathy including types of interventions used or recommended. METHODS: A scoping review of physical therapist interventions used to treat LHBT was conducted of the CINAHL, Embase, Medline, and SportDiscus databases. Full text records reporting physical therapist-based interventions in individuals with proximal LHBT pathology were included. Articles not written in English were excluded. RESULTS: Of the 4059 records identified, 14 articles met the inclusion criteria. Interventions used to treat LHBT tendinopathy identified in quantitative studies included: extracorporeal shock wave therapy, polarized light, ultrasound, low-level laser, iontophoresis, general exercise, eccentric training, stretching, dry needling, and joint mobilization. Interventions described in literature reviews, clinical commentaries, and a Delphi study included: therapeutic modalities, manual therapy, exercise, dry needling, and patient education. CONCLUSION: This scoping review reported interventions primarily based on therapeutic modalities in quantitative studies while literature reviews, clinical commentaries, and a Delphi study described the addition of manual therapy, patient education, exercise, and dry needling. Overall, there is a dearth of evidence detailing the conservative management of LHBT tendinopathy.

How Reproducible Are Manual Therapy Interventions in Trials for Low Back Pain? A Scoping Review.

OBJECTIVES: To assess the reproducibility of manual therapy interventions used in clinical trials for low back pain (LBP), and summarize knowledge gaps in assessing the reproducibility of manual therapy interventions for LBP. DESIGN: Scoping review. LITERATURE SEARCH: PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Cochrane Central Register of Controlled Trials (CENTRAL), and Embase were searched for trials from inception through April 2023. STUDY SELECTION CRITERIA: Randomized controlled trials were included if they described the use of manual therapy to treat LBP in adults 18 to 65 years old and were accessible in English. DATA SYNTHESIS: The Consensus on Exercise Reporting Template (CERT) checklist, used for exercise reporting, was previously modified for manual therapy reporting. This 11-item modified CERT was used to extract details of manual therapy reporting in the included trials. Frequency counts were calculated to identify items most and least commonly reported. RESULTS: Of 128 trials, none reported all 11 items of the modified CERT. The most commonly reported items were the description of how the application of manual therapy was decided (n = 113, 88.3%) and a description of adjunct interventions provided (n = 82, 64.1%). The least reported items were the description of an associated home program (n = 27, 21.1%) and a detailed description of the application of manual therapy (n = 22, 17.2%). CONCLUSION: Reporting of manual therapy interventions in trials investigating LBP was poor overall, limiting the reproducibility of these treatments. Using a checklist designed explicitly for manual therapy intervention reporting may improve reproducibility of these interventions and help align clinical outcomes with experimental findings. J Orthop Sports Phys Ther 2024;54(4):1-10. Epub 29 January 2024. doi:10.2519/jospt.2024.12201.

Trials and tribulations of transparency related to inconsistencies between plan and conduct in peer-reviewed physiotherapy publications: A methodology review.

RATIONALE: The physiotherapy profession strives to be a leader in providing quality care and strongly recognizes the value of research to guide clinical practice. Adherence to guidelines for research reporting and conduct is a significant step towards high-quality, transparent and reproducible research. AIM/OBJECTIVE: Assess integrity between planned and conducted methodology in randomized controlled trials (RCTs) and systematic reviews (SRs) published in physiotherapy journals. METHODS: Eighteen journals were manually searched for RCTs and SRs published from 1 July 2021 through 31 December 2021. Studies were included if the journal or specific study was indexed in PubMed and published/translated in English. Descriptive statistics determined congruence between preregistration data and publication. RESULTS: Forty RCTs and 68 SRs were assessed. Forty-three SRs included meta-analysis (MA). Of the 34 registered RCTs, 7 (20.6%) had no discrepancy between the registration and publication. Two trials (5.9%) addressed all discrepancies, 4 (11.8%) addressed some and 21 (61.8%) did not address any discrepancies. Of the 36 registered MAs, 33 (91.7%) had discrepancies between the registration and publication. Two (5.6%) addressed all discrepancies and three (8.3%) had no discrepancies. Eight SRs without MA published information not matching their registration, and none provided justification for the discrepancies. CONCLUSION: Most RCTs/SRs were registered; the majority had discrepancies between preregistration and publication, potentially influencing the outcomes and interpretations of findings. Journals should require preregistration and compare the submission with the registration information when assessing publication suitability. Readers should be aware of these inconsistencies and their implications when interpreting and translating results into practice.

Reproducibility of Exercise Interventions in Randomized Controlled Trials for the Treatment of Rotator Cuff-Related Shoulder Pain: A Systematic Review.

OBJECTIVE: To determine the reproducibility of exercise therapy interventions in randomized controlled trials for rotator cuff-related shoulder pain (RCRSP). DATA SOURCES: Data sources included Medline, Cumulative Index to Nursing and Allied Health Literature, Cochrane Central Register of Controlled Trials, and SPORTDiscus from studies published from database inception to April 23, 2022. STUDY SELECTION: Randomized controlled trials studying the use of exercise therapy for RCRSP. DATA EXTRACTION: Two reviewers extracted exercise reporting details from all studies using the Template for Intervention Description and Replication (TIDieR) and the modified Consensus on Exercise Reporting Template (CERT). The same 2 reviewers assessed risk of bias of all studies using Cochrane Risk of Bias Tool version 2.0. DATA SYNTHESIS: For 104 studies meeting inclusion criteria, the average number of items reported on the TIDieR was 5.27 (SD 2.50, range 1-12 out of 12) and 5.09 (SD 4.01, range 0-16 out of 16) on the CERT. Improved reporting over time was seen on both the TIDieR and CERT dating back to 1993 and through April 23, 2022. When comparing groups of studies published before and after the TIDieR (2014) and CERT (2016) were established, a statistically significant increase in median scores was noted on the TIDieR (P=.02) but not the CERT (P=.31). Quality of exercise therapy reporting was highest in studies with "low risk" of bias, and lowest in studies with "high risk" of bias on the RoB-2. CONCLUSION: Overall exercise reporting in trials for RCRSP is incomplete despite the development of the TIDieR and CERT checklists. This has implications for translating evidence into practice.

Evaluation of Transparency and Openness Guidelines in Physical Therapist Journals.

OBJECTIVE: The goals of this study were to evaluate the extent that physical therapist journals support open science research practices by adhering to the Transparency and Openness Promotion (TOP) guidelines and to assess the relationship between journal scores and their respective journal impact factor (JIF). METHODS: Scimago, mapping studies, the National Library of Medicine, and journal author guidelines were searched to identify physical therapist journals for inclusion. Journals were graded on 10 standards (29 available total points) related to transparency with data, code, research materials, study design and analysis, preregistration of studies and statistical analyses, replication, and open science badges. The relationship between journal transparency and openness scores and their JIF was determined. RESULTS: Thirty-five journals' author guidelines were assigned transparency and openness factor scores. The median score (interquartile range) across journals was 3.00 out of 29 (3.00) points (for all journals the scores ranged from 0 to 8). The 2 standards with the highest degree of implementation were design and analysis transparency (reporting guidelines) and study preregistration. No journals reported on code transparency, materials transparency, replication, and open science badges. TOP factor scores were a significant predictor of JIF scores. CONCLUSION: There is low implementation of the TOP standards by physical therapist journals. TOP factor scores demonstrated predictive abilities for JIF scores. Policies from journals must improve to make open science practices the standard in research. Journals are in an influential position to guide practices that can improve the rigor of publication which, ultimately, enhances the evidence-based information used by physical therapists. IMPACT: Transparent, open, and reproducible research will move the profession forward by improving the quality of research and increasing the confidence in results for implementation in clinical care.

Preoperative conservative treatment is insufficiently described in clinical trials of lumbar fusion: a scoping review.

PURPOSE: To identify how pre-surgical conservative care is characterized and reported in randomized controlled trials of adults undergoing elective lumbar fusion, including duration and type of treatment. METHODS: The study design is a scoping review. Data sources include PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Ovid Medline, EMBASE, and Cochrane Central Register of Controlled Trials (CENTRAL). All randomized controlled trials published in English between January 1, 2005, and February 15, 2022, assessing lumbar fusion as the intervention were included in this review. RESULTS: Of 166 studies, 62.0% reported a failure in conservative care prior to lumbar fusion, but only 15.1% detailed the type of specific conservative care received. None of the trials provided sufficient details to understand the nature of the pre-surgical conservative treatment, such as frequency, recency/timing, or dosage of conservative interventions. CONCLUSION: Although roughly two-thirds of trials reported that patients failed conservative care prior to receiving a lumbar fusion, few studies named the conservative intervention provided and no studies provided any details regarding dosing or recency of care. This lack of information creates ambiguity in the surgical decision-making process, setting the assumption that all patients received adequate conservative care prior to surgery. Details about pre-surgical conservative care should be disclosed to allow for appropriate clinical application, decision-making, and interpretation of treatment effects.

Trials Investigating Exercise for Low Back Pain Lack Pragmatic Application: A Systematic Review.

OBJECTIVE: To systematically review the orientation of trials analyzing exercise for low back pain (LBP) on the efficacy-effectiveness spectrum. DATA SOURCES: PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL), and Ovid MEDLINE were searched for trials published between January 1, 2010, and August 13, 2022. STUDY SELECTION: Randomized controlled trials investigating exercise for adults with LBP. DATA EXTRACTION: Two reviewers independently used the Rating of Included Trials on the Efficacy-Effectiveness Spectrum (RITES) tool to determine the efficacy-effectiveness orientation. The same 2 reviewers assessed the risk of bias for all studies using the Cochrane Collaboration risk of bias 2.0 tool. DATA SYNTHESIS: The search identified 2975 records. Full-text review was conducted on 674 studies, and 159 studies were included. The proportion of trials with a strong or rather strong efficacy orientation (RITES rating=1 or 2), balanced emphasis (RITES rating=3), or strong or rather strong effectiveness (RITES rating=4 or 5) orientation on the efficacy-effectiveness spectrum within each RITES domain were reported. A greater proportion of trials had an efficacy orientation when compared with effectiveness or a balanced emphasis within 4 domains: participant characteristics: efficacy 43.9%, 41.9% effectiveness, balanced 14.5%; trial setting: 69.0% efficacy, effectiveness 15.8% balanced 15.2%; flexibility of interventions: 74.2% efficacy, effectiveness 8.8%, balanced 17.0%; clinical relevance of experimental and comparison interventions: 50.3% efficacy, 33.3% effectiveness 33.3%, balanced 16.4%. A high risk of bias was found in 42.1% (n=67) of trials. CONCLUSION: Trials investigating the effect of exercise for LBP have a greater orientation toward efficacy across multiple trial design domains. Researchers should consider pragmatic designs in future trials to improve generalizability. Clinicians should consider the efficacy-effectiveness orientation when translating evidence into clinical practice.

Evaluating and Characterizing the Scope of Care for Interventions Labeled as Manual Therapy in Low Back Pain Trials: A Scoping Review.

OBJECTIVE: The purpose of this scoping review was to evaluate and characterize the scope of care for low back pain that falls under the specific label of manual therapy. METHODS: PubMed database, Ovid MEDLINE, EMBASE, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Cochrane Central Register of Controlled Trials (CENTRAL), and SPORTDiscus were searched from journal inception through May 2022 for randomized controlled trials that investigated the treatment of low back pain using manual therapy. Terminology used to define manual therapy was extracted and categorized by using only the words included in the description of the intervention. An expert consultation phase was undertaken to gather feedback. RESULTS: One hundred seventy-six trials met final inclusion criteria, and 169 unique terms labeled as manual therapy for the treatment of low back pain were found. The most frequent terms were mobilization (29.0%), manipulation (16.0%), and thrust (6.4%). Eight percent of trials did not define or specify what type of manual therapy was used in the study. After removing duplicates, 169 unique terms emerged within 18 categories. CONCLUSIONS: Manual therapy intervention labels used in low back pain trials are highly variable. With such variation, the heterogeneity of the intervention in trials is likely large, and the likelihood that different trials are comparing the same interventions is low. Researchers should consider being more judicious with the use of the term manual therapy and provide greater detail in titles, methods, and supplementary appendices in order to improve clarity, clinical applicability, and usefulness of future research. IMPACT: The ability to interpret and apply findings from manual therapy-related research for low back pain is challenging due to the heterogeneity of interventions under this umbrella term. A clear use of terminology and description of interventions by researchers will allow for improved understanding for the role of manual therapy in managing back pain.

What factors do physical therapists consider when determining patient prognosis: A mixed methods study.

INTRODUCTION: A prognosis provides valuable information to expected progress and anticipated outcome over the course of care. Although it is known that physical therapists can accurately prognose, it is unknown what factors are utilised in clinical practice. OBJECTIVE: The purpose of this study was to determine the prognostic domains and factors that influenced a PT's clinical reasoning processes. DESIGN: Mixed Methods Design, affirming the prognostic ability of the physical therapists and the qualitative exploration of the prognostic factors considered by physical therapists. METHODS: Twenty-nine physical therapists participated in this study. Participants underwent semi-structured qualitative interviews that were coded to populate a prognostic framework. In addition, de-identified patient data was used to determine the ability of the PT to form a prognosis. Linear regression was used to determine if an initial prognostic score was related to function at discharge. RESULTS: There were significant relationships (p = <0.05) between the prognosis score and Focus on Therapeutic Outcomes (B = 2.25), Numeric Pain Rating Scale (B = 0.257), and GROC (B = 0.289) upon patient discharge. Qualitative factors were categorised into prognostic domains (prevalence): Mood, Motivation, Pain Behaviours (100%), Disease Severity (93.1%), Health Status (86.2%), Social, Occupation, Environmental (67.0%), and Genetics, Biology, Biomarkers (44.8%). Factors that did not fit established domains were reported and categorised as Other (86.2%). CONCLUSION: Our findings support the relationship between PT prognosis of patients with musculoskeletal pain and patient outcomes. In addition, the domains and factors PTs use to formulate prognosis during evaluation present a complex biopsychosocial framework, suggesting that PTs consider factors from multiple domains when forming a prognosis.

Measures of sleep are not routinely captured in trials assessing treatment outcomes in knee osteoarthritis - A scoping systematic review and call to action.

Objective: To identify and map the extent to which trials for pain interventions in individuals with knee osteoarthritis (OA) track measures of sleep, characterize the type of sleep measure assessed, and assess their influence on pain-related effect sizes. Design: A scoping review was conducted, searching seven bibliometric databases from 2000 to 2022. We included all randomized controlled trials with a primary purpose of assessing non-surgical pain management interventions for adults with knee OA. All non-surgical interventions and any comparator or control were included. Demographic data were pooled from all trials. Results: 926 trials conducted in 61 countries met eligibility. Nineteen trials (2.1%) recorded some form of sleep assessment. Eleven trials (1.2%) assessed a formal index of sleep disturbance collected at multiple time points. No trials formally assessed the influence of sleep on the primary pain outcome (e.g., as a potential mediator), nor met the most recent guidelines for core data element recommendations regarding sleep assessment. Conclusion: This review highlights the paucity of sleep data captured and reported in randomized controlled trials for knee OA. The vast majority of trials addressing symptomatic knee OA do not capture sleep measures, significantly limiting the ability to accurately determine an intervention's effect on pain. Future research should include formal sleep-centric assessments measured at multiple time points to analyze sleep dysfunction and its relationship on treatment effects.

What are the unsupervised exercise adherence rates in clinical trials for knee osteoarthritis? A systematic review.

BACKGROUND: Exercise is an effective intervention for knee osteoarthritis (OA), and unsupervised exercise programs should be a common adjunct to most treatments. However, it is unknown if current clinical trials are capturing information regarding adherence. OBJECTIVE: To summarize the extent and quality of reporting of unsupervised exercise adherence in clinical trials for knee OA. METHODS: Reviewers searched five databases (PubMed, CINAHL, Medline (OVID), EMBASE and Cochrane). Randomized controlled trials where participants with knee OA engaged in an unsupervised exercise program were included. The extent to which exercise adherence was monitored and reported was assessed and findings were subgrouped according to method for tracking adherence. The types of adherence measurement categories were synthesized. A quality assessment was completed using the Physiotherapy Evidence Database (PEDro) scores. RESULTS: Of 3622 abstracts screened, 176 studies met criteria for inclusion. PEDro scores for study quality ranged from two to ten (mean=6.3). Exercise adherence data was reported in 72 (40.9%) studies. Twenty-six (14.8%) studies only mentioned collection of adherence. Adherence rates ranged from 3.7 to 100% in trials that reported adherence. For 18 studies (10.2%) that tracked acceptable adherence, there was no clear superiority in treatment effect based on adherence rates. CONCLUSIONS: Clinical trials for knee OA do not consistently collect or report adherence with unsupervised exercise programs. Slightly more than half of the studies reported collecting adherence data while only 40.9% reported findings with substantial heterogeneity in tracking methodology. The clinical relevance of these programs cannot be properly contextualized without this information.

The influence of pain-related comorbidities on pain intensity and pain-related psychological distress in patients presenting with musculoskeletal pain.

BACKGROUND: Musculoskeletal pain (MSP) is the largest contributor to chronic pain and frequently occurs alongside other medical comorbidities. OBJECTIVE: Explore the relationships between the presence of pain-related comorbidities, pain intensity, and pain-related psychological distress in patients with MSP. METHODS: A longitudinal assessment of individuals 18-90 years old in the Midwestern United States beginning a new episode of physical therapy for MSP. Electronic medical records were assessed the full year prior for care-seeking of diagnoses for pain-related comorbidities (anxiety, metabolic disorder, chronic pain, depression, nicotine dependence, post-traumatic stress disorder, sleep apnea, and sleep insomnia). Pain intensity and pain-related psychological distress (Optimal Screening for Prediction of Referral and Outcome - Yellow Flags tool) were captured during the physical therapy evaluation. Generalized linear models were used to assess the association between pain intensity, psychological distress, and pain-related co-morbidities. Models were adjusted for variables shown in the literature to influence pain. RESULTS: 532 participants were included in the cohort (56.4% female; median age of 59 years, Interquartile Range [IQR]:47, 69). Comorbid depression (beta coefficient (ß) = 0.7; 95%CI: 0.2, 1.2), spine versus lower extremity pain ((ß = 0.6; 95%CI: 0.1, 1.1), and prior surgery (ß = 0.8, 95%CI: 0.3, 1.4) were associated with higher pain intensity scores. No pain-related comorbidities were associated with pain-related psychological distress (yellow flag count or number of domains). Female sex was associated with less pain-related psychological distress (ß = -0.2, 95%CI: -0.3, -0.02). CONCLUSIONS: Depression was associated with greater pain intensity. No comorbidities were able to account for the extent of pain-related psychological distress.

Only 1% of Total Knee Arthroplasty Clinical Trials Report Patient Opioid Use Before or After Surgery: A Systematic Review.

OBJECTIVES: Many clinical trials report significant improvements in osteoarthritis-related pain and function after total knee arthroplasty (TKA). Opioids are commonly prescribed for pain management of knee osteoarthritis and also perioperative pain after surgery. The extent of persistent opioid use after TKA is unknown. Because up to 20% of individuals have poor outcomes after TKA and prior opioid use is a risk factor for future opioid use, treatment effects from TKA clinical trials would be better understood by assessing opioid use data from trial participants. The purpose of this review was to determine the proportion of participants in TKA trials with opioid use before surgery and persistent use after surgery and how well clinical trials capture and report these variables. MATERIALS AND METHODS: A systematic review of the literature (5 databases: CINAHL Cochrane CENTRAL, Embase, PubMed, and Web of Science) was conducted to assess the reporting of opioid use in TKA clinical trials. All opioid use was extracted, both prior and postoperatively. Long-term opioid use was determined using 4 different contemporary definitions to increase the sensitivity of the assessment. RESULTS: The search produced 24,252 titles and abstracts, and 324 met the final inclusion criteria. Only 4 of the 324 trials (1.2%) reported any type of opioid use; 1 identified prior opioid use, and none reported long-term opioid use after surgery. Only 1% of TKA clinical trials in the past 15 years reported any opioid use. DISCUSSION: Based on available research, it is not possible to determine if TKA is effective in reducing reliance on opioids for pain management. It also highlights the need to better track and report prior and long-term opioid use as a core outcome in future TKA trials.