Evidence map›Paper›PMID 38698433›Full record

ArticlePilot and feasibility studies2024

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

Javier Muñoz Laguna, Astrid Kurmann, Léonie Hofstetter, Emanuela Nyantakyi, Lauren Clack, Heejung Bang, Nadine E Foster, Julia Braun, Milo A Puhan, Mazda Farshad and 1 more

Registry-linked trialAbstract read
In one paragraph

Article in Pilot and feasibility studies, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05778396 (Feasibility of Blinding Spinal Manual Therapy Interventions for a Trial Assessing Management of Primary Care Patients With Back Pain), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05778396 nacompletednot on this map

Feasibility of Blinding Spinal Manual Therapy Interventions for a Trial Assessing Management of Primary Care Patients With Back Pain: the SALuBRITY Blinding Feasibility Randomised Controlled Trial

TypeinterventionalSponsorBalgrist University HospitalRan2023 to 2023Enrolled81ConditionsBack Pain, Back Pain With Radiation, Back Pain, LowArmsActive spinal manual therapy protocol, Control spinal manual therapy protocol
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Javier Muñoz LagunaEBPI-UWZH Musculoskeletal Epidemiology Research Group, University of Zurich and Balgrist University Hospital, Zurich, Switzerland.ORCID http://orcid.org/0000-0003-0332-5540
Astrid KurmannEBPI-UWZH Musculoskeletal Epidemiology Research Group, University of Zurich and Balgrist University Hospital, Zurich, Switzerland.ORCID https://orcid.org/0009-0004-2157-5222
Léonie HofstetterEBPI-UWZH Musculoskeletal Epidemiology Research Group, University of Zurich and Balgrist University Hospital, Zurich, Switzerland.ORCID http://orcid.org/0000-0001-6335-5149
Emanuela NyantakyiInstitute for Implementation Science in Health Care (IfIS), Medical Faculty, University of Zurich, Zurich, Switzerland.ORCID http://orcid.org/0000-0002-7740-7680
Lauren ClackInstitute for Implementation Science in Health Care (IfIS), Medical Faculty, University of Zurich, Zurich, Switzerland.ORCID http://orcid.org/0000-0002-5162-5188
Heejung BangDivision of Biostatistics, Department of Public Health Sciences, School of Medicine, University of California, Davis, United States.ORCID http://orcid.org/0000-0002-5755-9951
Nadine E FosterSurgical Treatment and Rehabilitation Service (STARS), STARS Education and Research Alliance, The University of Queensland and Metro North Health, Brisbane, Australia.ORCID http://orcid.org/0000-0003-4429-9756
Julia BraunEpidemiology, Biostatistics and Prevention Institute (EBPI), University of Zurich, Zurich, Switzerland.ORCID http://orcid.org/0000-0001-8359-6177
Milo A PuhanEpidemiology, Biostatistics and Prevention Institute (EBPI), University of Zurich, Zurich, Switzerland.ORCID http://orcid.org/0000-0003-4721-1879
Mazda FarshadUniversity Spine Centre Zurich (UWZH), Balgrist University Hospital, University of Zurich, Zurich, Switzerland.ORCID http://orcid.org/0000-0002-7190-1127
Cesar A HincapiéEBPI-UWZH Musculoskeletal Epidemiology Research Group, University of Zurich and Balgrist University Hospital, Zurich, Switzerland. cesar.hincapie@uzh.ch.ORCID http://orcid.org/0000-0002-7257-8122

Funding

European Centre for Chiropractic Research Excellence 46-2021-CH/CHSchweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung 32003B_208064
6 · The paper itself

Abstract

introductionBlinding 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 registrationNCT05778396.

Indexed as

BlindingDouble-blind methodLow back painSpinal manipulationTrial methodsTrial protocol

Identifiers

PMID38698433
PMCPMC11064349

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.