Feasibility of blinding spinal manual therapy interventions among participants and outcome assessors: protocol for a blinding feasibility trial

Muñoz Laguna, Javier; Kurmann, Astrid; Hofstetter, Léonie; Nyantakyi, Emanuela; Clack, Lauren; Bang, Heejung; Foster, Nadine E.; Braun, Julia; Puhan, Milo A.; Farshad, Mazda; Hincapié, Cesar A.

Abstract

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.

Citation

Muñoz Laguna, J., Kurmann, A., Hofstetter, L., Nyantakyi, E., Clack, L., Bang, H., Foster, N. E., Braun, J., Puhan, M. A., Farshad, M., & Hincapié, C. A. (in press). Feasibility of blinding spinal manual therapy interventions among participants and outcome assessors: protocol for a blinding feasibility trial. Pilot and Feasibility Studies, 10(1), Article 70. https://doi.org/10.1186/s40814-024-01492-6

• Journal Article Type: Other
• Acceptance Date: Apr 14, 2024
• Online Publication Date: May 2, 2024
• Deposit Date: May 8, 2024
• Publicly Available Date: May 8, 2024
• Journal: Pilot and Feasibility Studies
• Print ISSN: 2055-5784
• Electronic ISSN: 2055-5784
• Publisher: BioMed Central
• Peer Reviewed: Peer Reviewed
• Volume: 10
• Issue: 1
• Article Number: 70
• DOI: https://doi.org/10.1186/s40814-024-01492-6
• Keywords: Double-blind method, Spinal manipulation, Blinding, Low back pain, Trial protocol, Trial methods
• Public URL: https://keele-repository.worktribe.com/output/824044
• Publisher URL: https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-024-01492-6