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


METHODS
Pilot randomized controlled clinical trial.


METHODS
University-integrated medicine research clinic.


METHODS
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.


METHODS
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.
Osher Center for Integrative Medicine, University of California, San Francisco, CA, USA.
Michael
M
Patterson
Stephanie
S
Maurer
Shelley R
SR
Adler
Andrew L
AL
Avins
D005221:Fatigue / Q000175:diagnosis / Q000517:prevention & control*; D005260:Female; D006801:Humans; D008297:Male; D008405:Massage; D008875:Middle Aged; D009369:Neoplasms / Q000628:therapy*; D010349:Patient Compliance; D017060:Patient Satisfaction; D010865:Pilot Projects; D010919:Placebos; D011594:Psychometrics; D015203:Reproducibility of Results; D012107:Research Design; D012720:Severity of Illness Index
D010919:Placebos