Developing treatment and control conditions in a clinical trial of massage therapy for advanced cancer.
ABSTRACT The purpose of this article is to describe the challenges faced by a research team in developing treatment and control conditions in a study of the efficacy of massage therapy for advanced cancer. Five design considerations were addressed related to developing a massage therapy protocol: (1) dosage, that is, the number, spacing and length of treatments; (2) type of massage therapy; (3) degree to which the protocol for the treatment is standardized; (4) qualifications of the persons providing the treatment; and (5) conditions under which the treatment is provided. Five criteria for structuring the control condition of the study are elaborated: (1) equivalency of contact; (2) similarity of form; (3) minimum adverse or negative effects; (4) expectancy of therapeutic benefit; and (5) minimum therapeutic benefit.
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ABSTRACT: Objective. The purpose of this pilot study was to investigate and compare the effects of reflexology and Swedish massage therapy on physiologic stress, pain, and mood in older cancer survivors residing in nursing homes. Methods. An experimental, repeated-measures, crossover design study of 18 nursing home residents aged 75 or over and diagnosed with solid tumor in the past 5 years and following completion of cancer treatments. The intervention tested was 20 minutes of Swedish Massage Therapy to the lower extremities, versus 20 minute Reflexology, using highly specified protocols. Pre- and post-intervention levels of salivary cortisol, observed affect, and pain were compared in the Swedish Massage Therapy and Reflexology conditions. Results. Both Reflexology and Swedish Massage resulted in significant declines in salivary cortisol and pain and improvements in mood. Conclusions. Preliminary data suggest that studies of Swedish Massage Therapy and Reflexology are feasible in this population of cancer survivors typically excluded from trials. Both interventions were well tolerated and produced measurable improvements in outcomes. Further research is needed to explore the mechanisms underlying the potential benefits of these CAM modalities in this patient population.Evidence-based Complementary and Alternative Medicine 07/2012; 2012:456897. DOI:10.1155/2012/456897 · 2.18 Impact Factor
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ABSTRACT: In a previous trial of massage for osteoarthritis (OA) of the knee, we demonstrated feasibility, safety and possible efficacy, with benefits that persisted at least 8 weeks beyond treatment termination. We performed a RCT to identify the optimal dose of massage within an 8-week treatment regimen and to further examine durability of response. Participants were 125 adults with OA of the knee, randomized to one of four 8-week regimens of a standardized Swedish massage regimen (30 or 60 min weekly or biweekly) or to a Usual Care control. Outcomes included the Western Ontario and McMaster Universities Arthritis Index (WOMAC), visual analog pain scale, range of motion, and time to walk 50 feet, assessed at baseline, 8-, 16-, and 24-weeks. WOMAC Global scores improved significantly (24.0 points, 95% CI ranged from 15.3-32.7) in the 60-minute massage groups compared to Usual Care (6.3 points, 95% CI 0.1-12.8) at the primary endpoint of 8-weeks. WOMAC subscales of pain and functionality, as well as the visual analog pain scale also demonstrated significant improvements in the 60-minute doses compared to usual care. No significant differences were seen in range of motion at 8-weeks, and no significant effects were seen in any outcome measure at 24-weeks compared to usual care. A dose-response curve based on WOMAC Global scores shows increasing effect with greater total time of massage, but with a plateau at the 60-minute/week dose. Given the superior convenience of a once-weekly protocol, cost savings, and consistency with a typical real-world massage protocol, the 60-minute once weekly dose was determined to be optimal, establishing a standard for future trials. ClinicalTrials.gov NCT00970008.PLoS ONE 02/2012; 7(2):e30248. DOI:10.1371/journal.pone.0030248 · 3.53 Impact Factor
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ABSTRACT: The objective of this study was to determine the effects of physical therapy, including massage and exercise, on pain and mood in patients with advanced terminal cancer. The design was a randomized controlled pilot study. Twenty-four (24) patients with terminal cancer were randomly assigned to one of two treatment groups. Group A received a physiotherapy intervention consisting of several massage techniques, mobilizations, and local and global exercises. Group B received a simple hand contact/touch to areas of pain (cervical area, shoulder, interscapular area, heels, and gastrocnemius), which was maintained for the same period of time as the intervention group. All patients received six sessions of 30-35 minutes in duration over a 2-week period. Outcomes were collected at baseline, at 1 week, and at a 2-week follow-up (after treatment completion) by an assessor blinded to the treatment allocation of the participants. Outcomes included the Brief Pain Inventory (BPI, 0-10 scale), Memorial Pain Assessment Card (0-10 scale), and Memorial Symptom Assessment Scale (MSAS Physical, Psychological, 0-4 scale). Baseline between-group differences were assessed with an independent t-test. A two-way repeated-measures analysis of variance was used to examine the effects of the intervention. There were no significant between-group baseline differences (p>0.2). A significant group × time interaction with greater improvements in group A was found for BPI worst pain (F=3.5, p=0.036), BPI pain right now (F=3.94, p=0.027), and BPI index (F=13.2, p<0.001), for MSAS Psychological (F=8.480, p=0.001). The combination of massage and exercises can reduce pain and improve mood in patients with terminal cancer. A sustained effect on pain and psychologic distress existed; however, parameters such as physical distress and the least pain were no greater in the intervention group as compared to the sham.Journal of alternative and complementary medicine (New York, N.Y.) 04/2012; 18(5):480-6. DOI:10.1089/acm.2011.0277 · 1.52 Impact Factor