A novel clinical-trial design for the study of massage therapy

Abstract

Objectives: To develop and test the feasibility and acceptability of a structured design for a massage therapy clinical trial that included a treatment arm designed to control for the non-specific effects of a massage therapy intervention.

Design: Pilot randomized controlled clinical trial.

Setting: University-integrated medicine research clinic.

Interventions: Participants were randomized to a structured Swedish-style massage therapy intervention, a light-touch bodywork control intervention, or usual medical care. Details of the interventions are provided.

Main outcome measures: The primary outcome measures were the adherence of the participants to the study protocol and the perception of the intervention experience.

Results: Forty-four participants were randomized. Participants often found adherence to the twice-weekly outpatient bodywork interventions to be somewhat difficult; while, overall, 84% of participants completed the study, only 76% of those in an intervention arm successfully completed the trial. Participants randomized to the massage arm expressed uniformly positive attitudes both before and after the intervention. While some participants randomized to the light-touch bodywork arm initially expressed some reservations about their randomization assignment, all participants available for interview were pleased with their experience after the intervention period.

Conclusions: The proposed design was found to be relatively straightforward to implement and acceptable to participants. Early disappointment with not receiving massage therapy expressed by the light-touch intervention participants dissipated quickly. Twice-weekly outpatient intervention appointments were found to be highly burdensome for many patients actively undergoing chemotherapy, thus reducing adherence.

Trial registration: ClinicalTrials.gov NCT00039793.

Figures

Figure

Participant flow of CRAFT Study *One participant randomized to the low-intensity bodywork intervention received the mediumintensity bodywork intervention because of administrative scheduling problems.