Evidence map›Paper›PMID 39810207›Full record

Trial reportChiropractic & manual therapies2025

'Which treatment do you believe you received?' A randomised blinding feasibility trial of spinal manual therapy.

Javier Muñoz Laguna, Astrid Kurmann, Léonie Hofstetter, Emanuela Nyantakyi, Julia Braun, Lauren Clack, Heejung Bang, Mazda Farshad, Nadine E Foster, Milo A Puhan and 2 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Chiropractic & manual therapies, 2025. 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. Article
  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

12 authors.

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

Funding

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

Abstract

backgroundBlinding is essential for mitigating biases in trials of low back pain (LBP). Our main objectives were to assess the feasibility of blinding: (1) participants randomly allocated to active or placebo spinal manual therapy (SMT), and (2) outcome assessors. We also explored blinding by levels of SMT lifetime experience and recent LBP, and factors contributing to beliefs about the assigned intervention.

methodsA two-parallel-arm, single-centre, placebo-controlled, blinding feasibility trial. Adults were randomised to active SMT (n = 40) or placebo SMT (n = 41). Participants attended two study visits for their assigned intervention, on average seven days apart. The primary outcome was participant blinding (beliefs about assigned intervention) using the Bang blinding index (BI) at two study visits. The Bang BI is arm-specific, chance-corrected, and ranges from - 1 (all incorrect beliefs) to 1 (all correct beliefs), with 0 indicating equal proportions of correct and incorrect beliefs. Secondary outcomes included factors contributing to beliefs about the assigned intervention.

resultsOf 85 adults screened, 81 participants were randomised (41 [51%] with SMT lifetime experience; 29 [39%] with recent LBP), and 80 (99%) completed follow-up. At study visit 1, 50% of participants in the active SMT arm (Bang BI: 0.50 [95% confidence interval (CI), 0.26 to 0.74]) and 37% in the placebo SMT arm (0.37 [95% CI, 0.10 to 0.63]) had a correct belief about their assigned intervention, beyond chance. At study visit 2, BIs were 0.36 (0.08 to 0.64) and 0.29 (0.01 to 0.57) for participants in the active and placebo SMT arms, respectively. BIs among outcome assessors suggested adequate blinding at both study visits (active SMT: 0.08 [- 0.05 to 0.20] and 0.03 [- 0.11 to 0.16]; placebo SMT: - 0.12 [- 0.24 to 0.00] and - 0.07 [- 0.21 to 0.07]). BIs varied by participant levels of SMT lifetime experience and recent LBP. Participants and outcome assessors described different factors contributing to their beliefs.

conclusionsAdequate blinding of participants assigned to active SMT may not be feasible with the intervention protocol studied, whereas blinding of participants in the placebo SMT arm may be feasible. Blinding of outcome assessors seemed adequate. Further methodological work on blinding of SMT is needed. TRIAL REGISTRATION NUMBER: NCT05778396.

Indexed as

Low Back PainManipulation, SpinalAdultFeasibility StudiesFemaleHumansMaleMiddle AgedYoung AdultBack painBlinding successDouble-blind methodFeasibility studyManual therapyMaskingRandomised controlled trialSpinal manipulation

Identifiers

PMID39810207
PMCPMC11730787

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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.