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Review
. 2022 Aug 8;22(1):219.
doi: 10.1186/s12874-022-01704-8.

Differences between experimental and placebo arms in manual therapy trials: a methodological review

Giandomenico D'Alessandro  1   2 , Nuria Ruffini  1   3 , Alessandro Aquino  1   4 , Matteo Galli  1   5 , Mattia Innocenti  2 , Marco Tramontano  6 , Francesco Cerritelli  7
Affiliations
Review

Differences between experimental and placebo arms in manual therapy trials: a methodological review

Giandomenico D'Alessandro et al. BMC Med Res Methodol. .

Erratum in

Abstract

Background: To measure the specific effectiveness of a given treatment in a randomised controlled trial, the intervention and control groups have to be similar in all factors not distinctive to the experimental treatment. The similarity of these non-specific factors can be defined as an equality assumption. The purpose of this review was to evaluate the equality assumptions in manual therapy trials.

Methods: Relevant studies were identified through the following databases: EMBASE, MEDLINE, SCOPUS, WEB OF SCIENCE, Scholar Google, clinicaltrial.gov, the Cochrane Library, chiloras/MANTIS, PubMed Europe, Allied and Complementary Medicine (AMED), Physiotherapy Evidence Database (PEDro) and Sciencedirect. Studies investigating the effect of any manual intervention compared to at least one type of manual control were included. Data extraction and qualitative assessment were carried out independently by four reviewers, and the summary of results was reported following the PRISMA statement.

Result: Out of 108,903 retrieved studies, 311, enrolling a total of 17,308 patients, were included and divided into eight manual therapy trials categories. Equality assumption elements were grouped in three macro areas: patient-related, context-related and practitioner-related items. Results showed good quality in the reporting of context-related equality assumption items, potentially because largely included in pre-existent guidelines. There was a general lack of attention to the patient- and practitioner-related equality assumption items.

Conclusion: Our results showed that the similarity between experimental and sham interventions is limited, affecting, therefore, the strength of the evidence. Based on the results, methodological aspects for planning future trials were discussed and recommendations to control for equality assumption were provided.

Keywords: Manual placebo; Manual therapies; Placebo, similarity; Sham therapy; Systematic review.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flow-chart of the study
Fig. 2
Fig. 2
Equality assumption for patient-related characteristics of the included studies
Fig. 3
Fig. 3
Equality assumption for context-related characteristics of the included studies. Acu Acupressure, Mas Massage, Rei Reiki, TT Therapeutic Touch, Mob Mobilisation, Man Manipulation, Mix Mixed-Method
Fig. 4
Fig. 4
Equality assumption for practitioner-related characteristics of the included studies. Acu Acupressure, Mas Massage, Rei Reiki, TT Therapeutic Touch, Mob Mobilisation, Man Manipulation, Mix Mixed-Method
See this image and copyright information in PMC

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