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

Laguna, Javier Muñoz; Nyantakyi, Emanuela; Bhattacharyya, Urmila; Blum, Kathrin; Delucchi, Matteo; Klingebiel, Felix Karl-Ludwig; Labarile, Marco; Roggo, Andrea; Weber, Manuel; Radtke, Thomas; Puhan, Milo A.; Hincapié, Cesar A.

doi:10.1186/s12998-023-00524-x

Please use this identifier to cite or link to this item: https://doi.org/10.21256/zhaw-29831

Publication type:	Article in scientific journal
Type of review:	Peer review (publication)
Title:	Is blinding in studies of manual soft tissue mobilisation of the back possible? : a feasibility randomised controlled trial with Swiss graduate students
Authors:	Laguna, Javier Muñoz Nyantakyi, Emanuela Bhattacharyya, Urmila Blum, Kathrin Delucchi, Matteo Klingebiel, Felix Karl-Ludwig Labarile, Marco Roggo, Andrea Weber, Manuel Radtke, Thomas Puhan, Milo A. Hincapié, Cesar A.
et. al:	No
DOI:	10.1186/s12998-023-00524-x 10.21256/zhaw-29831
Published in:	Chiropractic & Manual Therapies
Volume(Issue):	32
Issue:	1
Page(s):	3
Issue Date:	29-Jan-2024
Publisher / Ed. Institution:	BioMed Central
ISSN:	2045-709X
Language:	English
Subjects:	Method; Blinding assessment; Manual therapy; Back pain; Double-blind method; Clinical trial
Subject (DDC):	615: Pharmacology and therapeutics 617.5: Orthopaedic surgery
Abstract:	Study design: Single-centre, two-parallel group, methodological randomised controlled trial to assess blinding feasibility. Background: Trials 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. Methods: On 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. Results: 24 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. Conclusions: Blinding 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 registration: ClinicalTrials.gov: NCT05822947 (retrospectively registered)
URI:	https://digitalcollection.zhaw.ch/handle/11475/29831
Fulltext version:	Published version
License (according to publishing contract):	CC BY 4.0: Attribution 4.0 International
Departement:	Life Sciences and Facility Management
Organisational Unit:	Institute of Computational Life Sciences (ICLS)
Appears in collections:	Publikationen Life Sciences und Facility Management

Files in This Item:

File	Description	Size	Format
2024_Laguna-etal_Blinding-in-studies-of-manual-soft-tissue-mobilisation-back.pdf		1.6 MB	Adobe PDF	View/Open

Show full item record

Laguna, J. M., Nyantakyi, E., Bhattacharyya, U., Blum, K., Delucchi, M., Klingebiel, F. K.-L., Labarile, M., Roggo, A., Weber, M., Radtke, T., Puhan, M. A., & Hincapié, C. A. (2024). Is blinding in studies of manual soft tissue mobilisation of the back possible? : a feasibility randomised controlled trial with Swiss graduate students. Chiropractic & Manual Therapies, 32(1), 3. https://doi.org/10.1186/s12998-023-00524-x

Laguna, J.M. et al. (2024) ‘Is blinding in studies of manual soft tissue mobilisation of the back possible? : a feasibility randomised controlled trial with Swiss graduate students’, Chiropractic & Manual Therapies, 32(1), p. 3. Available at: https://doi.org/10.1186/s12998-023-00524-x.

J. M. Laguna et al., “Is blinding in studies of manual soft tissue mobilisation of the back possible? : a feasibility randomised controlled trial with Swiss graduate students,” Chiropractic & Manual Therapies, vol. 32, no. 1, p. 3, Jan. 2024, doi: 10.1186/s12998-023-00524-x.

LAGUNA, Javier Muñoz, Emanuela NYANTAKYI, Urmila BHATTACHARYYA, Kathrin BLUM, Matteo DELUCCHI, Felix Karl-Ludwig KLINGEBIEL, Marco LABARILE, Andrea ROGGO, Manuel WEBER, Thomas RADTKE, Milo A. PUHAN und Cesar A. HINCAPIÉ, 2024. Is blinding in studies of manual soft tissue mobilisation of the back possible? : a feasibility randomised controlled trial with Swiss graduate students. Chiropractic & Manual Therapies. 29 Januar 2024. Bd. 32, Nr. 1, S. 3. DOI 10.1186/s12998-023-00524-x

Laguna, Javier Muñoz, Emanuela Nyantakyi, Urmila Bhattacharyya, Kathrin Blum, Matteo Delucchi, Felix Karl-Ludwig Klingebiel, Marco Labarile, et al. 2024. “Is Blinding in Studies of Manual Soft Tissue Mobilisation of the Back Possible? : A Feasibility Randomised Controlled Trial with Swiss Graduate Students.” Chiropractic & Manual Therapies 32 (1): 3. https://doi.org/10.1186/s12998-023-00524-x.

Laguna, Javier Muñoz, et al. “Is Blinding in Studies of Manual Soft Tissue Mobilisation of the Back Possible? : A Feasibility Randomised Controlled Trial with Swiss Graduate Students.” Chiropractic & Manual Therapies, vol. 32, no. 1, Jan. 2024, p. 3, https://doi.org/10.1186/s12998-023-00524-x.