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

NCT03100539 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 395

Last updated 2024-09-20

Study results available
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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.

Conditions

Interventions

OTHER

Therapist treated massage

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.

OTHER

Care ally assisted massage

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.

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Matthew J. Bair, MD MS · Richard L. Roudebush VA Medical Center, Indianapolis, IN

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-01
Primary Completion
2023-02-28
Completion
2023-02-28

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03100539 on ClinicalTrials.gov