CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 395 enrolled
Drug / intervention
Therapist treated massage +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03100539
NCT03100539N/ACompleted

Trial Outcomes for Massage: Caregiver-Assisted vs. Therapist-Treated (TOMCATT)

VA Office of Research and Development·interventional·Posted Apr 4, 2017·Updated Sep 20, 2024

In Brief

A clinical study evaluating Therapist treated massage and Care ally assisted massage for Neck Pain and 5 related conditions. Completed, enrolled 395 participants across 1 site.

Detailed Summary

Given the modest effectiveness of current treatments and the burden chronic neck pain places on Veterans, the investigators' research proposal is significant in several regards. First, Trial Outcomes for Massage: Caregiver-Assisted vs. Therapist-Treated (TOMCATT) Study directly addresses a high priority area for the VA and is well aligned with the VHA Pain Management Strategy and VHA Pain Management Directive 2009-053. Second, because previous massage studies have included relatively small sample sizes, this trial will provide information vital to fill an evidence vacuum regarding effectiveness of a massage treatments for chronic neck pain. Third, TOMCATT will extend the current understanding of non-pharmacological treatments. Fourth, if the study hypotheses are corroborated massage may emerge as an effective, safe, affordable, sustainable, and accessible treatment for Veterans.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedApr 4, 2017
Enrollment StartMay 1, 2017
Primary CompletionFeb 28, 2023
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 9.2 years ago

Interventions

Therapist treated massageother

Participants randomized to the therapist-treated massage (TT-M) arm will receive a standardized Swedish massage protocol tailored to chronic neck pain. Massage sessions will involve a maximum of 60 minutes of hands-on, table time and occur twice a week (a frequency which balances practicality and efficacy) for 3 months.

Care ally assisted massageother

CA-M consisted of in-person training for veteran/care-ally dyads to learn a standardized 30-minue massage routine, instructional DVD, and printed treatment manual. Participants were to complete three care ally-assisted massage sessions weekly for 12-weeks.