T Chase1, A Jha, C A Brooks, A Allshouse. 1. Patient & Family Education Program, Nursing Deptartment, Craig Hospital, Englewood, Denver, CO, USA.
Abstract
OBJECTIVE: To determine the feasibility of conducting a randomized controlled trial of massage therapy for patients with a new spinal cord injury (SCI) during acute inpatient rehabilitation. DESIGN: A pilot single-center, randomized, single-blind, cross-over clinical trial. SETTING: Free-standing, not-for-profit, comprehensive rehabilitation center specializing in SCI rehabilitation. PARTICIPANTS: Forty adults ages 18 years and older undergoing acute rehabilitation following an SCI reporting any type of pain. INTERVENTION: Rehabilitation nurses trained to give broad compression massage (BCM) and a control light contact touch (LCT) treatments. Participants were randomized to receive either BCM or LCT first, in six 20-min treatment sessions over 2 weeks, with a 1-week washout between the 2-week treatment periods. MAIN OUTCOME MEASURES: Primary outcomes were changes in pain intensity and in fatigue, measured daily. Secondary outcomes included depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9) and an assessment of pain medication usage. RESULTS:Pain intensity was higher at baseline and reduced more in the LCT-first group compared with the BCM-first group in period 1 (P=0.014), although this pattern was not found in period 2 (P=0.58). LCT and BCM groups did not significantly differ on any secondary measures except PHQ-9. CONCLUSIONS: This study demonstrates the feasibility of using rehabilitation nurses to provide tactile therapy to patients with an SCI and suggests a model for controlled clinical trials examining the efficacy of massage therapies. Although efficacy was difficult to assess, BCM was safe and well tolerated.
RCT Entities:
OBJECTIVE: To determine the feasibility of conducting a randomized controlled trial of massage therapy for patients with a new spinal cord injury (SCI) during acute inpatient rehabilitation. DESIGN: A pilot single-center, randomized, single-blind, cross-over clinical trial. SETTING: Free-standing, not-for-profit, comprehensive rehabilitation center specializing in SCI rehabilitation. PARTICIPANTS: Forty adults ages 18 years and older undergoing acute rehabilitation following an SCI reporting any type of pain. INTERVENTION: Rehabilitation nurses trained to give broad compression massage (BCM) and a control light contact touch (LCT) treatments. Participants were randomized to receive either BCM or LCT first, in six 20-min treatment sessions over 2 weeks, with a 1-week washout between the 2-week treatment periods. MAIN OUTCOME MEASURES: Primary outcomes were changes in pain intensity and in fatigue, measured daily. Secondary outcomes included depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9) and an assessment of pain medication usage. RESULTS:Pain intensity was higher at baseline and reduced more in the LCT-first group compared with the BCM-first group in period 1 (P=0.014), although this pattern was not found in period 2 (P=0.58). LCT and BCM groups did not significantly differ on any secondary measures except PHQ-9. CONCLUSIONS: This study demonstrates the feasibility of using rehabilitation nurses to provide tactile therapy to patients with an SCI and suggests a model for controlled clinical trials examining the efficacy of massage therapies. Although efficacy was difficult to assess, BCM was safe and well tolerated.
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