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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Neck Pain, Chronic Pain, Pain, Arthritis, Musculoskeletal Pain, Osteoarthritis

Intervention / Treatment
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* Other: Therapist treated massage


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapist treated massage (TT-M)<br>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: Therapist treated massage<br>* 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.<br>* Other names: TT-M;|
| No Intervention: Wait list control (WL-C)<br>Participants in the waitlist control will be instructed to continue their medical care as normal and to not begin any massage treatment during the 6 months of the study. At the competition of the final 6 month outcome, participants in the control arm will be eligible to attend a caregiver training session and receive a complementary massage session from a TOMCATT study therapist. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neck Disability index | The NDI is the standard instrument for measuring self-rated disability due to neck pain. The NDI was developed as a modification of the well-validated Oswestry Low Back Pain Disability Index. The NDI consists of 10-items that assess pain and functioning. All items are framed as a problem right now and are scored on a 6-point numeric rating scores of 0 to 5, with 5 being worst. The total score ranges from 0 to 50, with higher scores representing greater disability from chronic neck pain. The NDI has strong internal consistency (Cronbach's alpha = 0.80) and construct validity. Scoring of the NDI involves: 1) summing the score for each item (raw score); or 2) raw score can be multiplied by 2 to produce a percentage score. The following scoring intervals aid interpretation: 0 - 4 = no disability; 5 - 14 = mild; 15 - 24 = moderate; 25 - 34 = severe; and > 34 = complete disability. At least a 5-point change is defined as clinically meaningful. | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief pain inventory (BPI) | The Brief Pain Inventory is an 11-item, multidimensional pain measurement tool with reliability in patients with arthritis as well as other pain conditions. The BPI rates the intensity of pain as well as the interference of pain with mood, physical activity, work, social activity, relations, sleep, and enjoyment of life. | baseline, 1,3 and 6 month outcomes | 
| Patient Reported Outcomes Measurement Information System (PROMIS) pain | Pain interference will be assessed with the 4-item short form included in the PROMIS-29 Profile designed to measure physical functioning as a part of overall self-reported health and validated in large clinical and community samples | baseline, 1,3 and 6 month outcomes | 
| Medical outcomes study Veterans RAND 36 Item Health Survey (VR-36) (modified from Medical Outcomes Study SF-36) | Health-related quality of life will be measured with the VR-36, a modified version of the Medical Outcomes Study SF-36 widely used in VA research and available in the public domain. Internal consistency is high. | baseline, 1,3 and 6 month outcomes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Massage, Fascia