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

> **NIH VA I01** · RLR VA MEDICAL CENTER · 2020 · —

## Abstract

Background: Neck pain is the fourth leading cause of disability in the US, after back pain, depression,
and joint pain, and accounts for more than 10 million medical visits per year. Conventional treatments
(medications, physical therapy) are widely used for chronic neck pain, yet have modest effectiveness
and may carry risks, such as the toxicities associated with non-steroidal anti-inflammatory drugs
(NSAIDs) and opioids. As a result many patients live with chronic, often debilitating, pain. Patients
unable to find relief frequently turn to complementary health approaches. Complementary therapies are
exceptionally popular among Veterans; 82% reported use of at least one complementary therapy and
nearly all (99%) were willing to try massage for pain relief. Neck pain is the second most common
reason for using a complementary therapy, with massage used for neck pain more commonly than all
other complementary therapies except chiropractic care. Of all complementary approaches, massage
was the most preferred by Veterans. In a national survey, almost two-thirds (61%) of individuals with
neck pain who used both complementary and conventional treatments perceived complementary to be
more helpful, whereas only 6% perceived conventional treatments to be better.
Objectives: The Trial Outcomes for Massage: Caregiver-Assisted vs. Therapist-Treated (TOMCATT)
Study is a 3-arm, parallel group, randomized clinical trial that will last 6 months. The TOMCATT Study
will target 468 Veterans with chronic neck pain and will compare caregiver-assisted massage and
therapist-treated massage to a waitlist control arm on primary, secondary, and exploratory outcomes.
Methods: Our study sample will include 468 veterans with chronic neck pain. Patients from the 5
primary care clinics at the Roudebush VA Medical Center (RVAMC) and 3 community based outpatient
clinics (Terre Haute, Martinsville, and Bloomington) will be recruited to participate. The Trial Outcomes
for Massage: Caregiver-Assisted vs. Therapist-Treated (TOMCATT) Study will be a 3-arm, parallel
group, randomized clinical trial. Eligible participants will be randomized to one of three study arms: 1)
The caregiver-assisted (CA-M) arm will involve a standardized 3-month, massage routine; and 2)
Patients in the therapist-treated arm will receive 3 months of twice weekly massage delivered by
certified massage therapists. The third and comparator arm will be a waitlist control. The trial will last 6
months and compare caregiver-assisted and therapist-delivered massage to control on neck pain
outcomes. We will compare changes in pain-related disability (primary outcome) between the three
groups (Aim 1) and examine secondary outcomes: pain severity, quality of life, depression, anxiety, and
stress (Aim 2) as well as exploratory outcomes. To examine the implementation potential of both
interventions, including facilitators and barriers, we will conduct post-study, in-depth qualitative
interviews of a subsample of study p...

## Key facts

- **NIH application ID:** 9757610
- **Project number:** 5I01HX002035-03
- **Recipient organization:** RLR VA MEDICAL CENTER
- **Principal Investigator:** Matthew John Bair
- **Activity code:** I01 (R01, R21, SBIR, etc.)
- **Funding institute:** VA
- **Fiscal year:** 2020
- **Award amount:** —
- **Award type:** 5
- **Project period:** 2017-02-01 → 2021-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9757610

## Citation

> US National Institutes of Health, RePORTER application 9757610, Trial Outcomes for Massage: Caregiver-Assisted vs. Therapist-Treated (TOMCATT) (5I01HX002035-03). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9757610. Licensed CC0.

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