Randomized Trial Outcomes for Massage: Care Ally-Assisted vs. Therapist Treated (TOMCATT) Study Methods (Preprint)

BACKGROUND Chronic neck pain is prevalent and reduces functional status, quality of life, and is associated with deleterious psychological outcomes in affected individuals. Despite desirability for massage and its demonstrated effectiveness for chronic neck pain, multiple accessibility barriers exist. Caregiver applied massage approaches have demonstrated feasibility in various populations but has not been examined in Veterans with chronic neck pain or compared in parallel to therapist-delivered massage. 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 6months (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. CLINICALTRIAL ClinicalTrials.gov NCT03100539)