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Effects of massage on pain intensity, analgesics and quality of life in patients with cancer pain: a pilot study of a randomized clinical trial conducted within hospice care delivery
Wilkie DJ, Kampbell J, Cutshall S, Halabisky H, Harmon H, Johnson LP, Weinacht L, Rake-Marona M
The Hospice Journal 2000;15(3):31-53
clinical trial
4/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

AIMS: In a randomized controlled clinical trial (RCCT), we examined the effects of four massages on pain intensity, prescribed IM morphiine equivalent doses (IMMSEQ), hospital admissions, and quality of life (QoL). METHODS: Of 173 referred patients, 29 (14 control, 15 massage) completed this pilot study. Subjects were 69% male and aged 63 years on average. Licensed therapists administered four, twice-weekly massages. Baseline and outcome measurements were obtained by other team members before the first and after the fourth massages. RESULTS: Pain intensity, pulse rate, and respiratory rate were significantly reduced immediately after the massages. At study entry, the massage group reported highter pain intensity (2.4 +/- 2.8 versus 1.6 +/- 2.1) which decreasaed by 42% (1.4 +/- 1.5) compared to a 25% reduction in the control group (1.2 +/- 1.3) (p > 0.05). IMMSEQ doses were stable or decreased for eight patients in each group and increased for seven massage and six control group patients. One massage group and two control group patients were hospitalized. All initial QoL scores were higher in the massage group than in the control group, but only current QoL was statistically significant. Both groups reported improved global QoL. The control group reported slight improvement in current QoL and satisfaction with QoL whereas these two aspects of QoL declined in the massage group even though their average QoL scores were higher than the control group at the ned of the study. CONCLUSIONS: We demonstrated feasibility of conducting an RCCT in which we systematically implemented massage as a nonpharmacologic comfort therapy along with our usual hospice care. The massage intervention produced immediate relaxation and pain relief effects. A power analysis based on trends in the longer-term effects indicate that a study with 80 subjects per group is likely to detect statistically significant effects of usual hospice care with twice-weekly massage therapy sessions on pain intensity, analgesic dosages, and quality of life. Lessons we learned from conducting this pitot study are being used to improve documentation of our hospice program outcomes and to plan a definitive study.

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