Andrea J Cook1, Robert D Wellman2, Daniel C Cherkin2, Janet R Kahn3, Karen J Sherman4. 1. Group Health Research Institute, 1730 Minor Ave, Suite 1600, Seattle, WA 98101, USA; Department of Biostatistics, University of Washington, 1959 NE Pacific Street, Health Sciences Building F-600, Box 357232, Seattle, WA 98195, USA. Electronic address: cook.aj@ghc.org. 2. Group Health Research Institute, 1730 Minor Ave, Suite 1600, Seattle, WA 98101, USA. 3. Department of Psychiatry, University of Vermont College of Medicine, 1 South Prospect Street, MS 446AR6, Burlington, VT 05401, USA. 4. Group Health Research Institute, 1730 Minor Ave, Suite 1600, Seattle, WA 98101, USA; Department of Epidemiology, University of Washington, 1959 NE Pacific Street, Health Sciences Building F-250, Box 357236, Seattle, WA 98195, USA.
Abstract
BACKGROUND CONTEXT: This is the first study to systematically evaluate the value of a longer treatment period for massage. We provide a framework of how to conceptualize an optimal dose in this challenging setting of nonpharmacologic treatments. PURPOSE: The aim was to determine the optimal dose of massage for neck pain. STUDY DESIGN/ SETTING: Two-phase randomized trial for persons with chronic nonspecific neck pain. Primary randomization to one of five groups receiving 4 weeks of massage (30 minutes 2x/or 3x/wk or 60 minutes 1x, 2x, or 3x/wk). Booster randomization of participants to receive an additional six massages, 60 minutes 1x/wk, or no additional massage. PATIENT SAMPLE: A total of 179 participants from Group Health and the general population of Seattle, WA, USA recruited between June 2010 and August 2011 were included. OUTCOME MEASURES: Primary outcomes self-reported neck-related dysfunction (Neck Disability Index) and pain (0-10 scale) were assessed at baseline, 12, and 26 weeks. Clinically meaningful improvement was defined as greater than or equal to 5-point decrease in dysfunction and greater than or equal to 30% decrease in pain from baseline. METHODS: Clinically meaningful improvement for each primary outcome with both follow-up times was analyzed using adjusted modified Poisson generalized estimating equations (GEEs). Secondary analyses for the continuous outcomes used linear GEEs. RESULTS: There were no observed differences by primary treatment group at 12 or 26 weeks. Those receiving booster dose had improvements in both dysfunction and pain at 12 weeks (dysfunction: relative risk [RR]=1.56 [1.08-2.25], p=.018; pain: RR=1.25 [0.98-1.61], p=.077), but those were nonsignificant at 26 weeks (dysfunction: RR=1.22 [0.85-1.74]; pain: RR=1.09 [0.82-1.43]). Subgroup analysis by primary and booster treatments found the booster dose only effective among those initially randomized to one of the 60-minute massage groups. CONCLUSIONS: "Booster" doses for those initially receiving 60 minutes of massage should be incorporated into future trials of massage for chronic neck pain.
RCT Entities:
BACKGROUND CONTEXT: This is the first study to systematically evaluate the value of a longer treatment period for massage. We provide a framework of how to conceptualize an optimal dose in this challenging setting of nonpharmacologic treatments. PURPOSE: The aim was to determine the optimal dose of massage for neck pain. STUDY DESIGN/ SETTING: Two-phase randomized trial for persons with chronic nonspecific neck pain. Primary randomization to one of five groups receiving 4 weeks of massage (30 minutes 2x/or 3x/wk or 60 minutes 1x, 2x, or 3x/wk). Booster randomization of participants to receive an additional six massages, 60 minutes 1x/wk, or no additional massage. PATIENT SAMPLE: A total of 179 participants from Group Health and the general population of Seattle, WA, USA recruited between June 2010 and August 2011 were included. OUTCOME MEASURES: Primary outcomes self-reported neck-related dysfunction (Neck Disability Index) and pain (0-10 scale) were assessed at baseline, 12, and 26 weeks. Clinically meaningful improvement was defined as greater than or equal to 5-point decrease in dysfunction and greater than or equal to 30% decrease in pain from baseline. METHODS: Clinically meaningful improvement for each primary outcome with both follow-up times was analyzed using adjusted modified Poisson generalized estimating equations (GEEs). Secondary analyses for the continuous outcomes used linear GEEs. RESULTS: There were no observed differences by primary treatment group at 12 or 26 weeks. Those receiving booster dose had improvements in both dysfunction and pain at 12 weeks (dysfunction: relative risk [RR]=1.56 [1.08-2.25], p=.018; pain: RR=1.25 [0.98-1.61], p=.077), but those were nonsignificant at 26 weeks (dysfunction: RR=1.22 [0.85-1.74]; pain: RR=1.09 [0.82-1.43]). Subgroup analysis by primary and booster treatments found the booster dose only effective among those initially randomized to one of the 60-minute massage groups. CONCLUSIONS: "Booster" doses for those initially receiving 60 minutes of massage should be incorporated into future trials of massage for chronic neck pain.
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