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Differences between experimental and placebo arms in manual therapy trials: a methodological review
Giandomenico D'Alessandro1,2, Nuria Ruffini1,3, Alessandro Aquino1,4
1Clinical-Based Human Research Department, Foundation C.O.ME. Collaboration, 65121, Pescara, Italy.
BMC Medical Research Methodology
|August 8, 2022
Summary
Equality assumptions in manual therapy trials are often not met, particularly regarding patient and practitioner factors. This limits the strength of evidence for treatment effectiveness. Future trials need improved methodological controls.
Area of Science:
- Clinical Trials
- Manual Therapy
- Evidence-Based Practice
Background:
- Randomized controlled trials (RCTs) require similar intervention and control groups to isolate treatment effects.
- Equality assumptions ensure that non-experimental factors do not bias results.
- This review focuses on evaluating equality assumptions in manual therapy research.
Purpose of the Study:
- To critically evaluate the reporting and adherence to equality assumptions in manual therapy randomized controlled trials.
- To identify areas where equality assumptions are well-reported and where improvements are needed.
Main Methods:
- A systematic literature search was conducted across multiple databases (e.g., EMBASE, MEDLINE, PEDro).
- Studies comparing manual interventions to manual controls were included.
- Data extraction and quality assessment were performed by four independent reviewers following PRISMA guidelines.
Main Results:
- 311 trials involving 17,308 patients were analyzed, categorized into eight manual therapy areas.
- Reporting of context-related equality assumption items was generally good, likely due to existing guidelines.
- Significant deficiencies were found in the reporting of patient-related and practitioner-related equality assumption items.
Conclusions:
- The limited similarity between experimental and sham interventions in manual therapy trials weakens the overall evidence base.
- Methodological improvements are recommended for future trial planning to better control for equality assumptions.
- Specific recommendations are provided to enhance the control of equality assumptions in manual therapy RCTs.
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