2022
DOI: 10.1186/s12874-022-01704-8
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Differences between experimental and placebo arms in manual therapy trials: a methodological review

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 t… Show more

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Cited by 13 publications
(13 citation statements)
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“…Eight studies performed sham manual therapy, however, each one performed it differently, demonstrating how this topic is still in debate and needs to be addressed. The sham intervention is defined as an intervention that does not have the same specificity and effect as the intervention technique [ 33 ]. Therefore, regarding the specific effect, setup, and condition required for the experimental intervention, then one must exclude these variables to create the sham intervention and apply it in the same place as the experimental intervention.…”
Section: Discussionmentioning
confidence: 99%
See 1 more Smart Citation
“…Eight studies performed sham manual therapy, however, each one performed it differently, demonstrating how this topic is still in debate and needs to be addressed. The sham intervention is defined as an intervention that does not have the same specificity and effect as the intervention technique [ 33 ]. Therefore, regarding the specific effect, setup, and condition required for the experimental intervention, then one must exclude these variables to create the sham intervention and apply it in the same place as the experimental intervention.…”
Section: Discussionmentioning
confidence: 99%
“…Therefore, regarding the specific effect, setup, and condition required for the experimental intervention, then one must exclude these variables to create the sham intervention and apply it in the same place as the experimental intervention. In a recent study by Giandomenico et al 2022, they suggest describing the following items for both intervention and sham groups: (i) type of touch; (ii) amount of pressure; (iii) type of movement and patient positioning; (iv) areas of contact; (v) time of contact; and (vi) practitioner’s characteristics [ 33 ]. In some of the included studies [ 21 , 24 – 26 , 28 ] was performed the sham technique over the same places as the experimental techniques, but superficially without applying pressure over deep structures.…”
Section: Discussionmentioning
confidence: 99%
“…To reduce the impact of confounding factors and improve the quality of manual therapy research, researchers have previously conducted comparative studies of real manual therapy and sham manual therapy [ 32 ]. The objective of the study was as follows: to add Maitland mobilization to routine rehabilitation training for CAI patients to explore whether there was a more positive improvement than routine rehabilitation alone or routine rehabilitation combined with sham manual therapy, and to determine the effectiveness of Maitland mobilization for CAI patients.…”
Section: Introductionmentioning
confidence: 99%
“…Furthermore, biases and limitations, such as small sample size, inadequate study length, short-term follow-up, and inadequate controls (placebo or sham), undermine the internal and external validity of RCTs in manual therapy [17]. In addition, control groups have several areas to be improved, such as maintaining conditions comparable to experimental interventions or ensuring the inertness of the sham technique [18,19]. Furthermore, a non-manual comparator (e.g., modalities-detuned ultrasound or laser) is often applied in RCTs instead of using proper manual comparators (e.g., sham touch, shame joint mobilization), which lack the characteristics of indistinguishability necessary to define it as 'placebo' [20].…”
mentioning
confidence: 99%