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INTRODUCTION: Blinding is a methodologically important aspect in randomised controlled trials yet frequently overlooked in trials of spinal manual therapy interventions for back pain. To help inform the blinding methods of a future, double-placebo-controlled trial comparing spinal manual therapy and nerve root injection for lumbosacral radicular pain, we set four objectives: (1) to assess the feasibility of blinding participants, randomly allocated to an active or placebo-control spinal manual therapy intervention protocol, (2) to assess the feasibility of blinding outcome assessors within the trial, (3) to explore the influence of spinal manual therapy experience and low back pain on blinding, and (4) to explore factors contributing to perceptions about intervention assignment among participants and outcome assessors. METHODS AND ANALYSIS: Two-parallel-group, single-centre, placebo-controlled, methodological blinding feasibility randomised trial. We will recruit between 60 and 100 adults with or without back pain and with or without experience of spinal manual therapy from Zurich, Switzerland. Participants will be randomised to either an active spinal manual therapy or a placebo-control spinal manual therapy protocol-both interventions delivered over two study visits, up to two weeks apart. The primary outcome is participant blinding using the Bang blinding index within each intervention arm immediately after each of the two study visits. Secondary outcomes are participant blinding using the James blinding index, outcome assessor blinding (Bang and James blinding indices), self-reported factors influencing perceived intervention assignment among participants and outcome assessors, and participant-reported credibility and expectancy of study interventions. Other outcomes-included to blind the study objective from participants-are lumbar spine range of motion, self-rated general health, satisfaction with care, pain intensity, and function. Intervention provider outcomes include intervention component fidelity and quality of intervention delivery. ETHICS AND DISSEMINATION: The independent ethics commission of Canton Zurich granted ethical approval for this study (KEK 2023-00381). Written informed consent will be obtained from all participants. Findings will be disseminated in scientific conferences and a peer-reviewed publication and inform the blinding methods of a future double-placebo controlled trial comparing spinal manual therapy and nerve root injection for lumbosacral radicular pain-the SALuBRITY trial. TRIAL REGISTRATION: NCT05778396.
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ABSTRACT: Musculoskeletal (MSK) conditions are often managed in primary care settings. To facilitate research and health care quality, practice-based research networks (PBRNs) offer sustained collaborations between clinicians and researchers. A scoping review was conducted to describe characteristics of PBRNs used for MSK research and MSK research conducted through PBRNs. PBRNs were identified from 1) MSK-studies identified In OVID Medline, CINAHL, and Embase databases from inception to 05 February 2023 and in ClinicalTrials.gov; and 2) from PBRN registries and websites. Among active MSK-focused PBRNs (i.e., currently recruiting and conducting research), an assessment of PBRN research good practices was performed. After screening 3025 records, 85 studies from 46 unique PBRNs met our eligibility criteria. Common conditions studied were low back pain (28%), MSK conditions not otherwise specified (25%), and osteoarthritis (19%). 32 PBRNs (70%) were deemed to be active. Among active MSK-focused PBRNs, best practice data management information was retrievable for most (53%). Due to the scarcity of publicly available information, a large proportion of PBRN research good practice items was not assessable. PBRNs have provided an avenue to assess clinical practice and patient outcomes related to MSK conditions. Further work to increase the transparency of MSK PBRN research practices is warranted.
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OBJECTIVES: Effective measurement and monitoring of health status in patients with spine-related musculoskeletal (MSK) disorders are essential for providing appropriate care and improving outcomes. Minimal clinical datasets are standardized sets of key data elements and patient-centered outcomes that can be measured and recorded during routine clinical care. Our scoping review aimed to identify and map current evidence on minimal clinical datasets for measuring and monitoring health status in patients with spine-related MSK disorders in primary and outpatient healthcare settings. STUDY DESIGN AND SETTING: We followed the JBI (formerly Joanna Briggs Institute) methodology for scoping reviews. MEDLINE, CINAHL, Cochrane Library, Index to Chiropractic Literature, MANTIS, ProQuest Dissertations and Theses Global, and medRxiv preprint repository were searched from database inception to August 1, 2021. Two reviewers independently screened titles and abstracts, full-text articles, and charted the evidence. Findings were synthesized and summarized descriptively. RESULTS: After screening 5,583 citations and 301 full-text articles, 104 studies about 32 individual minimal clinical datasets were included. Most minimal clinical datasets were developed for patient populations with spine-involving inflammatory arthritis, nonspecific or degenerative spinal pain, and MSK disorders in general. The minimal clinical datasets varied substantially in terms of the author-reported time-to-complete (1-48 minutes) and the number of items (5-100 items). Fifty percent of the datasets involved healthcare professionals in their development process, and only 28% involved patients. Health domain items were most frequently linked to the components of activities and participation (43.9%) and body functions (28.6%), according to the International Classification of Functioning, Disability, and Health. There is no standardized definition of minimal clinical datasets to measure and monitor health status of patients with spine-related MSK disorders in routine clinical practice. Common core elements identified were practicality, feasibility in a busy routine practice, time efficiency, and the capability to be used across different healthcare settings. CONCLUSION: Due to the absence of a standard definition for minimal clinical datasets for patients with spine-related MSK disorders, there is a lack of consistency in the selection of key data elements and patient-centered outcomes that should be included. More research on the implementation and feasibility of minimal clinical datasets in routine care settings is warranted and needed. It is essential to involve all relevant partners in the development process of minimal clinical datasets to ensure successful implementation and adoption in routine primary care.