Accepted for/Published in: JMIR Research Protocols
Date Submitted: Apr 22, 2022
Date Accepted: Jun 30, 2022
Therapist Delivered vs. Care Ally-Assisted Massage for Veterans with Chronic Neck Pain: TOMCATT Study Methods and Modified Design of a Randomized Control Trial
ABSTRACT
Background:
This manuscript describes the original study design, lessons learned, and resultant design modification for the Trial Outcomes for Massage: Care Ally-Assisted vs. Therapist Treated (TOMCATT) study.
Objective:
This manuscript describes the original study design, lessons learned, and resultant design modification for the Trial Outcomes for Massage: Care Ally-Assisted vs. Therapist Treated (TOMCATT) study.
Methods:
TOMCATT began as a 3-arm, randomized controlled trial of two massage delivery approaches for Veterans with chronic neck pain with measures collected at baseline, 1-, 3-(post-intervention), and 6-months (follow-up). Arm I: Care ally-assisted massage consisted of: i) in-person, 3.5-hour training workshop, ii) instructional DVD, iii) printed treatment manual, and iv) three, 30-minute at-home care ally-assisted massage sessions weekly for 3 months. Arm II: Therapist-treated massage consisted of two, 60-minute, tailored to individual pain experience, treatments per week for 3 months. Treatments followed a standardized Swedish massage approach protocol. Arm III: Wait-list control.
Results:
Retention and engagement challenges in the first 30 months were significant in the care ally-assisted massage study arm (63% attrition between randomization and treatment initiation) and prompted modification to a 2-arm trial; removing Arm I.
Conclusions:
The modified TOMCATT study successfully launched and exceeded recruitment goals 2.5 months prior to the necessary COVID-19 pause and is expected to be completed by early 2023. Clinical Trial: ClinicalTrials.gov NCT03100539
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Copyright
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