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

Muñoz Laguna, Javier; 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 (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) BioMed Central 10.1186/s12998-023-00524-x

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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’—alanced ‘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.

Item Type:	Journal Article (Original Article)
Division/Institute:	School of Health Professions School of Health Professions > Academic-Practice-Partnership Insel Gruppe/BFH
Name:	Muñoz Laguna, Javier; Nyantakyi, Emanuela; Bhattacharyya, Urmila; Blum, Kathrin; Delucchi, Matteo; Klingebiel, Felix Karl-Ludwig; Labarile, Marco; Roggo, Andrea; Weber, Manuel0000-0002-5866-9618; Radtke, Thomas; Puhan, Milo A and Hincapié, Cesar A
Subjects:	R Medicine > RM Therapeutics. Pharmacology
ISSN:	2045-709X
Publisher:	BioMed Central
Language:	English
Submitter:	Manuel Weber
Date Deposited:	29 Feb 2024 09:01
Last Modified:	03 Mar 2024 01:39
Publisher DOI:	10.1186/s12998-023-00524-x
ARBOR DOI:	10.24451/arbor.21303
URI:	https://arbor.bfh.ch/id/eprint/21303