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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.

Authors

Javier Muñoz Laguna

Astrid Kurmann

Léonie Hofstetter

Emanuela Nyantakyi

Lauren Clack

Heejung Bang

Nadine E. Foster

Julia Braun

Milo A. Puhan

Mazda Farshad

Cesar A. Hincapié



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., …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

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Feasibility of blinding spinal manual therapy interventions among participants and outcome assessors: protocol for a blinding feasibility trial (1.5 Mb)
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Licence
https://creativecommons.org/licenses/by/4.0/

Publisher Licence URL
https://creativecommons.org/licenses/by/4.0/

Copyright Statement
Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.




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