Alignment between the research question, design, and terminology is required in manual therapy trials: a...

Area of Science:

• Clinical Trials
• Manual Therapy Research
• Evidence-Based Practice

Background:

• Effectiveness trials (ETs) in manual therapy (MT) aim to reflect real-world clinical practice.
• Assessing the pragmatic nature and reporting quality of these trials is crucial for interpreting their findings.
• Understanding the influence of trial design, such as the use of placebo controls, on pragmatism is important.

Purpose of the Study:

• To evaluate the design, reporting standards, and risk of bias in manual therapy effectiveness trials.
• To compare pragmatic versus non-pragmatic trials and trials with and without placebo controls.
• To assess the clarity and consistency of pragmatic features within these studies.

Main Methods:

• Systematic search of MEDLINE and Cochrane Central Register of Controlled Trials for MT ETs up to January 2024.
• Data extraction on study characteristics, reporting, and risk of bias by two independent reviewers.
• Assessment using the PRagmatic Explanatory Continuum Indicatory Summary-2 (PRECIS-2) tool, followed by descriptive and relational analyses.

Main Results:

• 113 ETs were analyzed; 39 self-labeled as pragmatic, 39 used usual care/other interventions, and 35 used placebo controls.
• Trials demonstrated moderate pragmatism, irrespective of self-labeling or placebo control use, though pragmatic features were often unclear.
• Pragmatic elements were more evident in eligibility and recruitment but less so in intervention and setting; ETs were less likely to follow reporting guidelines compared to self-labeled pragmatic trials.

Conclusions:

• The term 'effectiveness' in manual therapy trials is used without consistent pragmatic implications.
• The choice of a placebo or active control group does not significantly alter the pragmatic approach of effectiveness trials.
• There is a need for clearer reporting and consistent application of pragmatic features in manual therapy effectiveness research.