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 participants (Veteran patients and caregivers) from both massage groups (Aim 3). Lastly, we 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 our 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.
Given the modest effectiveness of current treatments and the burden chronic neck pain places on veterans, our 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, our trial will provide information vital to fill an evidence vacuum regarding effectiveness of two different massage treatments for chronic neck pain. Third, TOMCATT will extend our 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.