Methodology
Development of a manualized protocol of massage therapy for clinical trials in osteoarthritis
1 Department of Pediatrics, Yale University School of Medicine, 2 Church Street South, New Haven, CT, 06519, USA
2 College of Medicine, University of Vermont, 240 Maple Street, Burlington, VT, 05401, USA
3 Yale-Griffin Prevention Research Center, Griffin Hospital, 130 Division Street, Derby, CT, 06418, USA
4 Duke Integrative Medicine, Duke University School of Medicine, 3475 Erwin Road, Durham, NC, 27710, USA
Trials 2012, 13:185 doi:10.1186/1745-6215-13-185
Published: 4 October 2012Abstract
Background
Clinical trial design of manual therapies may be especially challenging as techniques are often individualized and practitioner-dependent. This paper describes our methods in creating a standardized Swedish massage protocol tailored to subjects with osteoarthritis of the knee while respectful of the individualized nature of massage therapy, as well as implementation of this protocol in two randomized clinical trials.
Methods
The manualization process involved a collaborative process between methodologic and clinical experts, with the explicit goals of creating a reproducible semi-structured protocol for massage therapy, while allowing some latitude for therapists’ clinical judgment and maintaining consistency with a prior pilot study.
Results
The manualized protocol addressed identical specified body regions with distinct 30- and 60-min protocols, using standard Swedish strokes. Each protocol specifies the time allocated to each body region. The manualized 30- and 60-min protocols were implemented in a dual-site 24-week randomized dose-finding trial in patients with osteoarthritis of the knee, and is currently being implemented in a three-site 52-week efficacy trial of manualized Swedish massage therapy. In the dose-finding study, therapists adhered to the protocols and significant treatment effects were demonstrated.
Conclusions
The massage protocol was manualized, using standard techniques, and made flexible for individual practitioner and subject needs. The protocol has been applied in two randomized clinical trials. This manualized Swedish massage protocol has real-world utility and can be readily utilized both in the research and clinical settings.
Trial registration
Clinicaltrials.gov NCT00970008 (18 August 2009)
