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.

The Influence of Active, Passive, and Manual Therapy Interventions for Low Back Pain on Opioid Prescription and Health Care Utilization.

OBJECTIVE: The aim of this study was to explore associations between the utilization of active, passive, and manual therapy interventions for low back pain (LBP) with 1-year escalation-of-care events, including opioid prescriptions, spinal injections, specialty care visits, and hospitalizations. METHODS: This was a retrospective cohort study of 4827 patients identified via the Military Health System Data Repository who received physical therapist care for LBP in 4 outpatient clinics between January 1, 2015 and January 1, 2018. One-year escalation-of-care events were evaluated based on type of physical therapist interventions (ie, active, passive, or manual therapy) received using adjusted odds ratios. RESULTS: Most patients (89.9%) received active interventions. Patients with 10% higher proportion of visits that included at least 1 passive intervention had a 3% to 6% higher likelihood of 1-year escalation-of-care events. Similarly, with 10% higher proportion of passive to active interventions used during the course of care, there was a 5% to 11% higher likelihood of 1-year escalation-of-care events. When compared to patients who received active interventions only, the likelihood of incurring 1-year escalation-of-care events was 50% to 220% higher for those who received mechanical traction and 2 or more different passive interventions, but lower by 50% for patients who received manual therapy. CONCLUSION: Greater use of passive interventions for LBP was associated with elevated odds of 1-year escalation-of-care events. In addition, the use of specific passive interventions such as mechanical traction in conjunction with active interventions resulted in suboptimal escalation-of-care events, while the use of manual therapy was associated with more favorable downstream health care outcomes. IMPACT: Physical therapists should be judicious in the use of passive interventions for the management of LBP as they are associated with greater likelihood of receiving opioid prescriptions, spinal injections, and specialty care visits.

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.

Leveraging the Short-Term Benefits of Manual Therapy which Includes Exercise Over Exercise Therapy Alone Appears Justified for Knee Osteoarthritis.

Letter to the Editor-in-Chief in response to JOSPT article "The Benefits of Adding Manual Therapy to Exercise Therapy for Improving Pain and Function in Patients with Knee or Hip Osteoarthritis: A Systematic Review with Meta-analysis" by Runge et al. J Orthop Sports Phys Ther 2023;53(1):49-50. doi:10.2519/jospt.2023.0201.

The Effectiveness of a Mindfulness-Based Intervention Integrated with Physical Therapy (MIND-PT) for Postsurgical Rehabilitation After Lumbar Surgery: A Protocol for a Randomized Controlled Trial as Part of the Back Pain Consortium (BACPAC) Research Program.

BACKGROUND: Improving pain management for persons with chronic low back pain (LBP) undergoing surgery is an important consideration in improving patient-centered outcomes and reducing the risk of persistent opioid use after surgery. Nonpharmacological treatments, including physical therapy and mindfulness, are beneficial for nonsurgical LBP through complementary biopsychosocial mechanisms, but their integration and application for persons undergoing surgery for LBP have not been examined. This study (MIND-PT) is a multisite randomized trial that compares an enriched pain management (EPM) pathway that integrates physical therapy and mindfulness vs usual-care pain management (UC) for persons undergoing surgery for LBP. DESIGN: Participants from military treatment facilities will be enrolled before surgery and individually randomized to the EPM or UC pain management pathways. Participants assigned to EPM will receive presurgical biopsychosocial education and mindfulness instruction. After surgery, the EPM group will receive 10 sessions of physical therapy with integrated mindfulness techniques. Participants assigned to the UC group will receive usual pain management care after surgery. The primary outcome will be the pain impact, assessed with the Pain, Enjoyment, and General Activity (PEG) scale. Time to opioid discontinuation is the main secondary outcome. SUMMARY: This trial is part of the National Institutes of Health Helping to End Addiction Long-term (HEAL) initiative, which is focused on providing scientific solutions to the opioid crisis. The MIND-PT study will examine an innovative program combining nonpharmacological treatments designed to improve outcomes and reduce opioid overreliance in persons undergoing lumbar surgery.

Incomplete reporting of manual therapy interventions and a lack of clinician and setting diversity in clinical trials for neck pain limits replication and real-world translation. A scoping review.

INTRODUCTION: Neck pain is a leading cause of disability, and manual therapy (MT) is a common intervention used across disciplines and settings to treat it. While there is consistent support for MT in managing neck pain, questions remain about the feasibility of incorporating MT from research into clinical practice. The purpose of this scoping review was to assess the adequacy of MT intervention descriptions and the variability in clinician and setting for MT delivery in trials for neck pain. METHODS: Medline (via PubMed), CINAHL, PEDRo, and the Cochrane Central Registry for Controlled Trials were searched for clinical trials published from January 2010 to November 2021. A 11-item tool modified from the Consensus on Exercise Reporting Template was used to assess appropriateness of intervention reporting. Clinicians, subclassifications of neck pain, and clinical settings were also extracted. RESULTS: 113 trials were included. A low percentage of studies provided the recommended level of detail in the description of how MT was delivered (4.4%), while 39.0% included no description at all. Just over half of trials included clinician's qualifications (58.4%), dose of MT (59.3%), and occurrence of adverse events (55.8%). The proportion of trials with clinicians delivering MT were physical therapists (77.9%), chiropractors (10.6%), and osteopaths (2.7%). DISCUSSION/CONCLUSION: These results reveal incomplete reporting of essential treatment parameters, and a lack of clinician diversity. To foster reproducibility, researchers should report detailed descriptions of MT interventions. Future research should incorporate a variety of MT practitioners to improve generalizability.

Over Half of Clinical Trials of Mobilization and Manipulation for Patients With Low Back Pain May Have Limited Real-World Applicability: A Systematic Review of 132 Clinical Trials.

OBJECTIVE: To evaluate the existing body of trials assessing manual therapy for low back pain (LBP) to determine where it falls on the efficacyeffectiveness continuum. DESIGN: Methodology systematic review. LITERATURE SEARCH: PubMed, CINAHL (Cumulative Index to Nursing and Allied Health Literature), CENTRAL (Cochrane Central Register of Controlled Trials), and PEDro (Physiotherapy Evidence Database) were searched for trials published between January 1, 2000, and April 30, 2021. STUDY SELECTION CRITERIA: We included randomized clinical trials investigating joint mobilization and manipulation for adults with nonspecific LBP that were available in English. DATA SYNTHESIS: We used the Rating of Included Trials on the Efficacy-Effectiveness Spectrum (RITES) tool to score included trials across 4 domains: participant characteristics, trial setting, flexibility of intervention(s), and clinical relevance of experimental and comparison intervention(s). Proportions of trials with greater emphasis on efficacy or effectiveness were calculated for each domain. RESULTS: Of the 132 included trials, a greater proportion emphasized efficacy than effectiveness for domains participant characteristics (50% vs 38%), trial setting (71% vs 20%), and flexibility of intervention(s) (61% vs 25%). The domain clinical relevance of experimental and comparison intervention(s) had lower emphasis on efficacy (41% vs 50%). CONCLUSION: Most trials investigating manual therapy for LBP lack pragmatism across the RITES domains (ie, they emphasize efficacy). To improve real-world implementation, more research emphasizing effectiveness is needed. This could be accomplished by recruiting from more diverse participant pools, involving multiple centers that reflect common clinical practice settings, involving clinicians with a variety of backgrounds/experience, and allowing flexibility in how interventions are delivered. J Orthop Sports Phys Ther 2022;52(8):532-545. Epub: 19 June 2022. doi:10.2519/jospt.2022.10962.

Justice and equity in pragmatic clinical trials: Considerations for pain research within integrated health systems.

Introduction: Pragmatic clinical trials (PCTs) can overcome implementation challenges for bringing evidence-based therapies to people living with pain and co-occurring conditions, providing actionable information for patients, providers, health systems, and policy makers. All studies, including those conducted within health systems that have a history of advancing equitable care, should make efforts to address justice and equity. Methods: Drawing from collective experience within pragmatic pain clinical trials networks, and synthesizing relevant literature, our multidisciplinary working group examined challenges related to integrating justice and equity into pragmatic pain management research conducted in large, integrated health systems. Our analysis draws from military and veteran health system contexts but offers strategies to consider throughout the lifecycle of pragmatic research more widely. Results: We found that PCTs present a unique opportunity to address major influences on health inequities by occupying a space between research, healthcare delivery, and the complexities of everyday life. We highlight key challenges that require attention to support complementary advancement of justice and equity via pragmatic research, offering several strategies that can be pursued. Conclusions: Efforts are needed to engage diverse stakeholders broadly and creatively in PCTs, such as through dedicated health equity working groups and other collaborative relationships with stakeholders, to support robust and inclusive approaches to research design and implementation across study settings. These considerations, while essential to pain management research, offer important opportunities toward achieving more equitable healthcare and health systems to benefit people living with pain and co-occurring conditions.

What do patients referred to physical therapy for a musculoskeletal condition expect? A qualitative assessment.

BACKGROUND: Patient expectations related to physical therapy outcomes are commonly collected through surveys and close-ended questionnaires. These methods may not optimally capture patients' expectations for physical therapy, especially in the patients' own words. Louis Gifford identified four questions attempting to guide clinicians' understanding of patients' expectations for physical therapy. However, a qualitative assessment mapping the expectations that patients have prior to starting physical therapy appears to be undocumented. OBJECTIVES: The aim of this study was to determine patient expectations prior to beginning physical therapy for individuals with musculoskeletal conditions. DESIGN: Qualitative analysis with structured interviews and open-ended participant responses. METHODS: Twenty-five people (18 female, 7 male; mean age: 47.04 years) were interviewed prior to their initial physical therapy evaluation using a pragmatic approach rooted in phenomenology. Data were transcribed, coded, and thematized using qualitative data analysis software. RESULTS: Outcome, education, exercise, evaluation, and cause of pain were key themes expressed by participants. Participants appear to want to better understand their symptoms, how they can improve symptoms, what the clinician will do, and how long they will attend physical therapy. Many participants were not certain where physical therapy fit within their overall healthcare plan, and perceptions of manual therapy were vague. CONCLUSIONS: These identified themes highlight what patients may expect from a physical therapy experience and clinicians should work to identify and satisfy each patient's individual expectations to optimize outcomes.

The influence of manual therapy dosing on outcomes in patients with hip osteoarthritis: a systematic review.

OBJECTIVE: To 1) Determine if specific dosing parameters of manual therapy are related to improved pain, disability, and quality of life outcomes in patients with hip osteoarthritis and 2) to provide recommendations for optimal manual therapy dosing based on our findings. DESIGN: A systematic review of randomized controlled trials from the PubMed, CINAHL, and OVID databases that used manual therapy interventions to treat hip osteoarthritis was performed. Three reviewers assessed the risk of bias for included studies and extracted relevant outcome data based on predetermined criteria. Baseline and follow-up means and standard deviations for outcome measures were used to calculate effect sizes for within and between-group differences. RESULTS: Ten studies were included in the final analyses totaling 768 participants, and half were graded as high risk of bias. Trends emerged: 1) large effect sizes were seen using long-axis distraction, mobilization and thrust manipulation, 2) mobilization with movement showed large effects for pain and range of motion, and (3) small effects were associated with graded mobilization. Durations of 10 to 30 minutes per session, and frequency 2-3 times per week for 2-6 weeks were the most common dosing parameters. CONCLUSIONS: There were varied effect sizes associated with pain, function, and quality of life for both thrust and non-thrust mobilizations, and mobilization with movement into hip flexion and internal rotation. Due to the heterogeneity of MT dosage, it is difficult to recommend a specific manual therapy dosage for those with hip osteoarthritis.

Move to health-a holistic approach to the management of chronic low back pain: an intervention and implementation protocol developed for a pragmatic clinical trial.

BACKGROUND: The prevalence of chronic pain conditions is growing. Low back pain was the primary cause of disability worldwide out of 156 conditions assessed between 1990 and 2016, according to the Global Burden of Disease Study. Conventional medical approaches have failed to identify effective and long-lasting approaches for the management of chronic pain, and often fail to consider the multiple domains that influence overall health and can contribute to the pain experience. Leading international organizations that focus on pain research have stated the importance of considering these other domains within holistic and multidisciplinary frameworks for treating pain. While the research behind the theoretical link between these domains and chronic pain outcomes has expanded greatly over the last decade, there have been few practical and feasible methods to implement this type of care in normal clinical practice. METHODS: The purpose of this manuscript is to describe an implementation protocol that is being used to deliver a complex holistic health intervention at multiple sites within a large government health system, as part of a larger multisite trial for patients with chronic low back pain. The Move to Health program developed by the US Army Medical Command was tailored for specific application to patients with low back pain and begins by providing an empirical link between eight different health domains (that include physical, emotional, social, and psychological constructs) and chronic low back pain. Through a six-step process, a health coach leverages motivational interviewing and information from a personal health inventory to guide the patient through a series of conversations about behavioral lifestyle choices. The patient chooses which domains they want to prioritize, and the health coach helps implement the plan with the use of SMART (Specific, Measurable, Attainable, Realistic, Time-bound) goals and a series of resources for every domain, triaged from self-management to specialist referral. DISCUSSION: Complex interventions described in clinical trials are often challenging to implement because they lack sufficient details. Implementation protocols can improve the ability to properly deliver trial interventions into regular clinical practice with increased fidelity. TRIAL REGISTRATION: Implementation of this intervention protocol was developed for a clinical trial that was registered a priori (clinicaltrials.gov #NCT04172038).

Manual Therapy: Always a Passive Treatment?

SYNOPSIS: The use of manual therapy as an intervention has garnered intense debate, one that is often mired in a straw-man argument that manual therapy is a purely passive intervention. When passive interventions are equated with low-value care, it is easy to deride manual therapy as low-value care. However, manual therapy describes a wide variety of treatments, some with passive components and some that are primarily passive in certain scenarios. But manual therapy can be an integral part of highly active treatment strategies. We implore investigators to describe manual therapy interventions in sufficient detail so that they can be reproduced and thereby help the end users of research (including clinicians) to better assess the value of such interventions. This Viewpoint challenges the assumption that manual therapy is always a passive treatment of low value. J Orthop Sports Phys Ther 2021;51(10):474-477. Epub 1 Jul 2021. doi:10.2519/jospt.2021.10330.

Stakeholder Engagement in Pragmatic Clinical Trials: Emphasizing Relationships to Improve Pain Management Delivery and Outcomes.

BACKGROUND: The NIH-DOD-VA Pain Management Collaboratory (PMC) supports 11 pragmatic clinical trials (PCTs) on nonpharmacological approaches to management of pain and co-occurring conditions in U.S. military and veteran health organizations. The Stakeholder Engagement Work Group is supported by a separately funded Coordinating Center and was formed with the goal of developing respectful and productive partnerships that will maximize the ability to generate trustworthy, internally valid findings directly relevant to veterans and military service members with pain, front-line primary care clinicians and health care teams, and health system leaders. The Stakeholder Engagement Work Group provides a forum to promote success of the PCTs in which principal investigators and/or their designees discuss various stakeholder engagement strategies, address challenges, and share experiences. Herein, we communicate features of meaningful stakeholder engagement in the design and implementation of pain management pragmatic trials, across the PMC. DESIGN: Our collective experiences suggest that an optimal stakeholder-engaged research project involves understanding the following: i) Who are research stakeholders in PMC trials? ii) How do investigators ensure that stakeholders represent the interests of a study's target treatment population, including individuals from underrepresented groups?, and iii) How can sustained stakeholder relationships help overcome implementation challenges over the course of a PCT? SUMMARY: Our experiences outline the role of stakeholders in pain research and may inform future pragmatic trial researchers regarding methods to engage stakeholders effectively.

A Sequential Multiple-Assignment Randomized Trial (SMART) for Stepped Care Management of Low Back Pain in the Military Health System: A Trial Protocol.

BACKGROUND: The Defense Health Agency has prioritized system-level pain management initiatives within the Military Health System (MHS), with low back pain as one of the key focus areas. A stepped care model focused on nonpharmacologic treatment to promote self-management is recommended. Implementation of stepped care is complicated by lack of information on the most effective nonpharmacologic strategies and how to sequence and tailor the various available options. The Sequential Multiple-Assignment Randomization Trial for Low Back Pain (SMART LBP) is a multisite pragmatic trial using a SMART design to assess the effectiveness of nonpharmacologic treatments for chronic low back pain. DESIGN: This SMART trial has two treatment phases. Participants from three military treatment facilities are randomized to 6 weeks of phase I treatment, receiving either physical therapy (PT) or Army Medicine's holistic Move2Health (M2H) program in a package specific to low back pain. Nonresponders to treatment in phase I are again randomized to phase II treatment of combined M2H + PT or mindfulness-based treatment using the Mindfulness-Oriented Recovery Enhancement (MORE) program. The primary outcome is the Patient-Reported Outcomes Measurement Information System pain interference computer-adapted test score. SUMMARY: This trial is part of an initiative funded by the National Institutes of Health, Veterans Affairs, and the Department of Defense to establish a national infrastructure for effective system-level management of chronic pain with a focus on nonpharmacologic treatments. The results of this study will provide important information on nonpharmacologic care for chronic LBP in the MHS embedded within a stepped care framework.

Do the Number of Visits and the Cost of Musculoskeletal Care Improve Outcomes? More May Not Be Better.

OBJECTIVES: To determine the relationship between health care use and the magnitude of change in patient-reported outcomes in individuals who received treatment for subacromial pain syndrome. The secondary objective was to determine the value of care, as measured by change in pain and disability per dollar spent. DESIGN: Secondary analysis of a randomized clinical trial that investigated the effects of nonsurgical care for subacromial pain syndrome. METHODS: Two groups of treatment responders were created, based on 1-year change in Shoulder Pain and Disability Index (SPADI) score (high, 46.83 points; low, 8.21 points). Regression analysis was performed to determine the association between health care use and 1-year change in SPADI score. Baseline SPADI score was used as a covariate in the regression analysis. Value was measured by comparing health care visits and costs expended per SPADI 1-point change between responder groups. RESULTS: Ninety-eight patients were included; 38 were classified as high responders (mean 1-year SPADI change score, 46.83 points) and 60 were classified as low responders (1-year SPADI change score, 8.21 points). Neither unadjusted medical visits (5.89; 95% confidence interval [CI]: 4.35, 7.44 versus 6.30; 95% CI: 5.14, 7.46) nor medical costs ($1404.86; 95% CI: $1109.34, $1779.09 versus $1679.26; 95% CI: $1391.54, $2026.48) were significantly different between high and low responders, respectively. CONCLUSION: Neither the number of visits nor the financial cost of nonsurgical shoulder- related care was associated with improvement in shoulder pain and disability at 1 year. J Orthop Sports Phys Ther 2020;50(11):642-648. doi:10.2519/jospt.2020.9440.

Patients' perceptions with musculoskeletal disorders regarding their experience with healthcare providers and health services: an overview of reviews.

OBJECTIVES: This overview of reviews aimed to identify (1) aspects of the patient experience when seeking care for musculoskeletal disorders from healthcare providers and the healthcare system, and (2) which mechanisms are used to measure aspects of the patient experience. DATA SOURCES: Four databases were searched from inception to December 20th, 2019. REVIEW METHODS: Systematic or scoping reviews examining patient experience in seeking care for musculoskeletal from healthcare providers and the healthcare system were included. Independent authors screened and selected studies, extracted data, and assessed the methodological quality of the reviews. Patient experience concepts were compiled into five themes from a perspective of a) relational and b) functional aspects. A list of mechanisms used to capture the patient experience was also collected. RESULTS: Thirty reviews were included (18 systematic and 12 scoping reviews). Relational aspects were reported in 29 reviews and functional aspects in 25 reviews. For relational aspects, the most prevalent themes were "information needs" (education and explanation on diseases, symptoms, and self-management strategies) and "understanding patient expectations" (respect and empathy). For functional aspects, the most prevalent themes were patient's "physical and environmental needs," (cleanliness, safety, and accessibility of clinics), and "trusted expertise," (healthcare providers' competence and clinical skills to provide holistic care). Interviews were the most frequent mechanism identified to collect patient experience. CONCLUSIONS: Measuring patient experience provides direct insights about the patient's perspectives and may help to promote better patient-centered health services and increase the quality of care. Areas of improvement identified were interpersonal skills of healthcare providers and logistics of health delivery, which may lead to a more desirable patient-perceived experience and thus better overall healthcare outcomes. TRIAL REGISTRATION: Systematic review registration: PROSPERO (CRD42019136500).

The Influence of a Guideline-Concordant Stepped Care Approach on Downstream Health Care Utilization in Patients with Spine and Shoulder Pain.

BACKGROUND: Stepped care approaches are emphasized in guidelines for musculoskeletal pain, recommending less invasive or risky evidence-based intervention, such as manual therapy (MT), before more aggressive interventions such as opioid prescriptions. The order and timing of care can alter recovery trajectories. OBJECTIVE: To compare one-year downstream health care utilization in patients with spine or shoulder disorders who received only MT vs MT and opioids. The secondary aim was to compare differences based on order and timing of opioids and MT. DESIGN: Retrospective observational cohort. METHODS: Patients with an initial consultation for a spine or shoulder disorder who received at least one visit for MT were included. Person-level data from the Military Health System Management and Reporting Tool (M2) database were aggregated by a senior health care analyst at Madigan Army Medical Center. Groups were created based on the order and timing of interventions provided. Outcomes included health care utilization (medical costs and visits) over the year following initial consultation. Control measures included metabolic, mental health, chronic pain, sleep, and substance abuse comorbidities, as well as prior opioid prescriptions. Generalized linear models with gamma log links were run due to the heavily skewed nature of cost data. RESULTS: From 1,876 unique patients with spine or shoulder disorders receiving MT, 1,162 (61.9%) also received prescription opioids. Mean one-year costs in the MT-only group ($5,410, 95% confidence interval [CI] = $5,109 to $5,730) were significantly lower than in the MT+opioid group ($10,498, 95% CI = $10,043 to $10,973). When patients had both treatments, mean one-year costs in the MT-first ($10,782, 95% CI = $10,050 to $11,567) were significantly lower (P = 0.030) than opioid-first ($11,938, 95% CI = $11,272 to $12,643), and MT-first had a significantly lower mean days' supply of opioids (34.2 vs 70.9, P < 0.001) and mean number of unique opioid prescriptions (3.1 vs 6.5, P < 0.001). CONCLUSIONS: MT alone resulted in lower downstream costs than with opioid prescriptions. Both the order of treatment (MT before opioid prescriptions) and the timing of treatment (MT < 30 days) resulted in a significant reduction of resources (costs, visits, and opioid utilization) in the year after initial consultation. Clinicians should consider the implications of first-choice decisions and the timing of care for treatment choices utilized for patients with spine and shoulder disorders.

Dry needling in addition to standard physical therapy treatment for sub-acromial pain syndrome: a randomized controlled trial protocol.

BACKGROUND: Trigger point dry needling interventions are utilized by physical therapists to manage shoulder pain. Observational studies have shown positive short-term outcomes in patients with subacromial pain syndrome receiving trigger point dry needling. However, little research has been done to evaluate the long-term effectiveness of trigger point dry needling specifically as it compares to other commonly utilized interventions such as exercise and manual therapy. The purpose of this study is to assess the additive short and long-term effectiveness of trigger point dry needling to a standard physical therapy approach of manual therapy and exercise for patients with subacromial pain syndrome. METHODS: This multicenter randomized trial with 3 arms was designed following the standard protocol items for randomized interventional trials. Results will be reported consistent with the consolidated standards of reporting trials guidelines. 130 participants will be randomized to receive standard PT interventions alone (manual therapy and exercise), standard PT and trigger point dry needling or standard PT and sham trigger point dry needling. The primary outcome measures will be the Shoulder Pain and Disability Index and Patient Reported Outcomes Measurement Information Systems (PROMIS-57) scores collected at baseline, 6-weeks, 6-months and one year. Healthcare utilization will be collected for 12 months following enrollment and groups analyzed for differences. DISCUSSION: It is not known if trigger point dry needling provides long-term benefit for individuals with subacromial pain syndrome. This study will help determine if this intervention provides additive benefits over those observed with the commonly applied interventions of exercise and manual therapy. TRIAL REGISTRATION: Identifier: NCT03442894 (https://clinicaltrials.gov/ct2/show/NCT03442894) on 22 February 2018.