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

Abstract

Objectives: The study aimed to assess the design, reporting, and risk of bias in effectiveness trials (ETs) in manual therapy (MT), comparing pragmatic with nonpragmatic trials and trials with and without placebo controls. Study Design and Setting: We searched MEDLINE and the Cochrane Central Register of Controlled Trials for randomized controlled trials with the term “effectiveness” in the title or abstract in the field of MT from inception to January 2024. Two independent reviewers extracted data on specific study characteristics, their reporting, and risk of bias and assessed them using the PRagmatic Explanatory Continuum Indicatory Summary-2 tool (PRECIS-2). Descriptive analysis using frequencies and percentages and a relation analysis between PRECIS-2 scores and specific study characteristics were performed. Results: Of the 113 trials, 39 were self-labeled as pragmatic, 39 used usual care or other interventions, and 35 used placebo controls. ETs have increased in recent years. They are moderately pragmatic, whether they are self-described as pragmatic or not, and whether they use a placebo control group or not. Despite their aim to resemble clinical practice, the pragmatic features of these trials are often unclear. Pragmatic features are common in trials' eligibility, recruitment, and outcome domains, but intervention and setting are rated as very explanatory. Compared to self-labeled pragmatic trials, “effectiveness” trials are less likely to follow reporting guidelines. Conclusion: The term effectiveness is used in MT trials independently of its pragmatic connotations. Using a placebo or active control does not modify the pragmatic attitude of the ETs.