Clinical trial NCT03100539: Trial Outcomes for Massage: Caregiver-Assisted vs. Therapist-Treated
Official title: Trial Outcomes for Massage: Caregiver-Assisted vs. Therapist-Treated (TOMCATT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Chronic Pain
Pain
Arthritis
Musculoskeletal Pain
Osteoarthritis
Keywords: Massage
Fascia
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2017-04-04
Enrollment: 395
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Chronic neck pain for 6 months or longer
* Neck pain of at least moderate severity (NDI score greater than or equal to 10)

Exclusion Criteria:

* Neck pain secondary to vertebral fracture or metastatic cancer
* Complex neck pain (e.g. cervical radiculopathy or recent whiplash injury)
* Any massage professional massage therapy within the last 6 months
* Active suicidal ideation
* Moderate to severe cognitive impairment
* Pending neck surgery
* Involvement in active pain or massage trials

Primary outcomes:
measure: Neck Disability Index
timeFrame: Baseline
measure: Neck Disability Index
timeFrame: 1 Month
measure: Neck Disability Index
timeFrame: 3 Month
measure: Neck Disability Index
timeFrame: 6 Month
Secondary outcomes:
measure: Brief Pain Inventory (BPI)
timeFrame: Baseline
measure: Medical Outcomes Study Veterans RAND 36 Item Health Survey (VR-36) (Modified From Medical Outcomes Study SF-36)
timeFrame: Baseline
measure: Brief Pain Inventory (BPI)
timeFrame: 1 Month
measure: Brief Pain Inventory (BPI)
timeFrame: 3 Month
measure: Brief Pain Inventory (BPI)
timeFrame: 6 Month
measure: Medical Outcomes Study Veterans RAND 36 Item Health Survey (VR-36) (Modified From Medical Outcomes Study SF-36)
timeFrame: 1 Month
measure: Medical Outcomes Study Veterans RAND 36 Item Health Survey (VR-36) (Modified From Medical Outcomes Study SF-36)
timeFrame: 3 Month
measure: Medical Outcomes Study Veterans RAND 36 Item Health Survey (VR-36) (Modified From Medical Outcomes Study SF-36)
timeFrame: 6 Month
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Richard L. Roudebush VA Medical Center, Indianapolis, IN
state: Indiana
Study officials:
affiliation: Richard L. Roudebush VA Medical Center, Indianapolis, IN
name: Matthew J. Bair, MD MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Munk N, Daggy JK, Evans E, Kline M, Slaven JE, Laws B, Foote T, Matthias MS, Bair MJ. Therapist-Delivered Versus Care Ally-Assisted Massage for Veterans With Chronic Neck Pain: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Sep 27;11(9):e38950. doi: 10.2196/38950.