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 2-arm, parallel group, randomized clinical trial that will last 6
months. The TOMCATT Study will target 264 Veterans with chronic neck pain and will
compare therapist-treated massage to a waitlist control arm on primary, secondary, and
exploratory outcomes. There was previously an additional group staff randomized 102
Veterans and their Care Allies to, but are no longer randomizing into this group.
Methods: This study sample will include 264 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 2-arm, parallel group, randomized clinical
trial. Eligible participants will be randomized to one of two study arms: 1) Patients in
the therapist-treated arm will receive 3 months of twice weekly massage delivered by
certified massage therapists. The second and comparator arm will be a waitlist control.
The trial will last 6 months and compare therapist-delivered massage to control on neck
pain outcomes. The investigators will compare changes in pain-related disability (primary
outcome) between the two 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 the intervention, including facilitators and
barriers, the investigators will conduct post-study, in-depth qualitative interviews of a
subsample of study participants (Veteran patients and caregivers) the massage group and
the no-longer enrolling CAM group(Aim 3). Lastly, the investigators will assess treatment
fidelity and compare the relative intervention costs and budget impact for both
interventions. The intervention period will last for 3 months, after which time Veterans
will be followed for an additional 3 months.
Innovation: The TOMCATT Study is a novel extension of the investigators' prior work, has
strong implementation potential, and innovates by placing caregivers in a treatment
delivery role that has the potential to reach a greater number of Veterans with chronic
neck pain while also producing substantial cost-savings. Although studies have shown that
massage is effective for pain, caregiver-delivered strategies have not been tested or
implemented in any systematic way across VA.
