Evidence map›Paper›PMID 38287417›Full record

Trial reportChiropractic & manual therapies2024

Is blinding in studies of manual soft tissue mobilisation of the back possible? A feasibility randomised controlled trial with Swiss graduate students.

Javier Muñoz Laguna, Emanuela Nyantakyi, Urmila Bhattacharyya, Kathrin Blum, Matteo Delucchi, Felix Karl-Ludwig Klingebiel, Marco Labarile, Andrea Roggo, Manuel Weber, Thomas Radtke and 2 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Chiropractic & manual therapies, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05822947 (Blinding Assessment of Manual Therapy Interventions of the Back in Swiss Graduate Students), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
4.5field-weighted citation impact, top 6% of its field
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.

NCT05822947 nacompletednot on this map

Blinding Assessment of Manual Therapy Interventions of the Back in Swiss Graduate Students: a Blinding Feasibility Randomized Controlled Trial

TypeinterventionalSponsorCesar A Hincapié, DC PhDRan2022 to 2022Enrolled24ConditionsBack Pain, Back Disorder, Back Pain, LowArmsActive manual therapy, Control manual therapy
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 10 citations in OpenAlex.

  1. Trial
  2. Trial
  3. 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 at 3 institutions in 2 countries.

Javier Muñoz LagunaEBPI-UZWH Musculoskeletal Epidemiology Research Group, University of Zurich, Zurich, Switzerland. javier.munozlaguna@uzh.ch.ORCID 0000-0003-0332-5540
Emanuela NyantakyiFaculty of Medicine, Institute for Implementation Science in Health Care, University of Zurich, Zurich, Switzerland.ORCID 0000-0002-7740-7680
Urmila BhattacharyyaInstitute of Evolutionary Medicine (IEM), University of Zurich, Zurich, Switzerland.ORCID 0000-0003-2316-7359
Kathrin BlumFaculty of Medicine, Institute for Implementation Science in Health Care, University of Zurich, Zurich, Switzerland.ORCID 0000-0002-4383-0528
Matteo DelucchiCentre of Computational Health, Institute of Computational Life Sciences, Zurich University of Applied Sciences (ZHAW), Zurich, Switzerland.ORCID 0000-0002-9327-1496
Felix Karl-Ludwig KlingebielDepartment of Trauma, University Hospital Zurich, Zurich, Switzerland.ORCID 0000-0002-6438-5208
Marco LabarileDivision of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, Zurich, Switzerland.ORCID 0000-0002-0694-3865
Andrea RoggoDepartment of Dermatology, University Hospital Zurich, Zurich, Switzerland.ORCID 0000-0002-9517-5174
Manuel WeberSchool of Health Professions, Academic-Practice-Partnership between Bern University of Applied Sciences and University Hospital of Bern, Bern University of Applied Sciences, Bern, Switzerland.ORCID 0000-0002-5866-9618
Thomas RadtkeEpidemiology, Biostatistics and Prevention Institute (EBPI), University of Zurich, Zurich, Switzerland.ORCID 0000-0002-1723-1070
Milo A PuhanEpidemiology, Biostatistics and Prevention Institute (EBPI), University of Zurich, Zurich, Switzerland.ORCID 0000-0003-4721-1879
Cesar A HincapiéEBPI-UZWH Musculoskeletal Epidemiology Research Group, University of Zurich, Zurich, Switzerland.ORCID 0000-0002-7257-8122
University of Zurich · CHUniversity Hospital of Zurich · CHBern University of Applied Sciences · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

STUDY

designSingle-centre, two-parallel group, methodological randomised controlled trial to assess blinding feasibility.

backgroundTrials of manual therapy interventions of the back face methodological challenges regarding blinding feasibility and success. We assessed the feasibility of blinding an active manual soft tissue mobilisation and control intervention of the back. We also assessed whether blinding is feasible among outcome assessors and explored factors influencing perceptions about intervention assignment.

methodsOn 7-8 November 2022, 24 participants were randomly allocated (1:1 ratio) to active or control manual interventions of the back. The active group (n = 11) received soft tissue mobilisation of the lumbar spine. The control group (n = 13) received light touch over the thoracic region with deep breathing exercises. The primary outcome was blinding of participants immediately after a one-time intervention session, as measured by the Bang blinding index (Bang BI). Bang BI ranges from -1 (complete opposite perceptions of intervention received) to 1 (complete correct perceptions), with 0 indicating 'random guessing'-balanced 'active' and 'control' perceptions within an intervention arm. Secondary outcomes included blinding of outcome assessors and factors influencing perceptions about intervention assignment among both participants and outcome assessors, explored via thematic analysis.

results24 participants were analysed following an intention-to-treat approach. 55% of participants in the active manual soft tissue mobilisation group correctly perceived their group assignment beyond chance immediately after intervention (Bang BI: 0.55 [95% confidence interval (CI), 0.25 to 0.84]), and 8% did so in the control group (0.08 [95% CI, -0.37 to 0.53]). Bang BIs in outcome assessors were 0.09 (-0.12 to 0.30) and -0.10 (-0.29 to 0.08) for active and control participants, respectively. Participants and outcome assessors reported varying factors related to their perceptions about intervention assignment.

conclusionsBlinding of participants allocated to an active soft tissue mobilisation of the back was not feasible in this methodological trial, whereas blinding of participants allocated to the control intervention and outcome assessors was adequate. Findings are limited due to imprecision and suboptimal generalisability to clinical settings. Careful thinking and consideration of blinding in manual therapy trials is warranted and needed.

trial registrationClinicalTrials.gov: NCT05822947 (retrospectively registered).

Indexed as

Musculoskeletal ManipulationsFeasibility StudiesHumansSwitzerlandBack painBlinding assessmentClinical trialDouble-blind methodManual therapyMethods

Identifiers

PMID38287417
PMCPMC10826218
OpenAlexW4391312854

What OpenQuestion holds

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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.