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IIR 15-333 – HSR&D Study

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IIR 15-333
Trial Outcomes for Massage: Caregiver-Assisted vs. Therapist-Treated (TOMCATT)
Matthew J. Bair MD MS
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, IN
Funding Period: February 2017 - January 2021

BACKGROUND/RATIONALE:
Data from the 2012 National Health Interview Survey indicate that during a 3-month period, 15% of adults reported neck pain. The 12-month prevalence of chronic neck pain is estimated to be between 30%-50%. Neck pain is especially common in adults older than 50 years and is the fourth leading cause of disability in the United States, after back pain, depression, and joint pain. In a 2008 VA study, Dobsha et al. found back and neck pain diagnoses were present in 67% of 401 Veterans. In another VA study, the two most common cervical spine diagnoses were stenosis (50%) and disk herniation (23%). In Veterans with these diagnoses, neck pain was reported by 96%. The impact of chronic neck pain is widespread, exerting negative effects on individuals' physical, psychological, and economic well-being. Chronic neck pain reduces functional status, quality of life, and is associated with deleterious psychological outcomes, including depression and anxiety. Chronic neck pain is a major reason for health care utilization, accounting for more than 10 million ambulatory medical visits per year. The economic impact of this utilization is significant.

Guidelines highlight a wide range of treatment options for chronic neck pain. In clinical practice, conventional treatments such as medications and physical therapy are most widely used. However, systematic reviews conclude there is still limited evidence for the effectiveness of these treatments for neck pain, relative to low back pain, and current therapies show only modest effect sizes. The mainstay of chronic neck pain treatment is non-steroidal anti-inflammatory drugs (NSAIDs), but NSAIDs often provide suboptimal pain relief, especially when used as mono-therapy, and their adverse effects, such as gastrointestinal, renal, and cardiovascular complications, are well known. Opioids for chronic neck pain are controversial for several reasons. First, their long-term efficacy is questionable. Second, opioids are associated with several problematic side effects. Third, opioids have potential for misuse, abuse, and addiction. Fourth, between 1999 and 2008, the rate of prescription opioid overdose deaths in the US raised four-fold. Thus, when medications and physical therapy fail to relieve pain, Veterans frequently live with chronic, often debilitating, pain. Clearly, effective and safer treatments to improve the management of neck pain are needed.

The National Center for Complementary and Integrative Health (NCCIH, formerly NCCAM) defines complementary health approaches as practices or products of non-mainstream origin. Patient demand for these approaches (previously termed complementary and alternative medicine, CAM) is high. More than 30% of US adults use complementary health care approaches outside of, or integrated within, conventional treatment. Fifty-eight percent of older adults surveyed used some type of alternative treatment. Pain is the primary reason individuals turn to complementary treatments. After low back pain, neck pain is the second most common pain condition for complementary health use. Massage is the second (after chiropractic) most commonly used complementary treatment for neck pain. Complementary health approaches are especially popular and in high demand by Veterans. In a VA study, 82% of Veterans reported use of at least one complementary therapy and nearly all (99%) were willing to try such approaches for pain. Of all complementary health approaches, massage was the most preferred by Veterans. Massage's popularity derives from its patient-centered and healing-oriented approach and emphasis on the therapeutic relationship.

Safer alternatives to conventional pain treatments such as NSAIDS and opioids are needed, especially in older adults. Dr. Josephine Briggs, Director of NCCIH stated: "The need for nondrug treatment options (for pain) is a significant and urgent public health imperative." Experts also argue that clinicians and patients need to reduce reliance on pharmacological treatment. It is in this context the VA implemented the high-priority, Opioid Safety Initiative (OSI). The OSI grew out of accumulating evidence that some opioid use is unsafe and may be contributing to harm for Veterans. In addition to reducing use of high-dose (> 200mg a day) opioids and concomitant opioids and benzodiazepines, a major goal of the OSI is to provide safer alternatives for treating chronic pain. To accomplish this latter goal, VA facilities are being encouraged to implement programs that improve access to complementary health approaches, like massage therapy. Existing studies show massage is safe for all ages--it has few risks if it is used appropriately, and serious adverse effects are rare.

In a review of complementary health approaches for neck pain, massage reduced pain and/or disability more than usual medical care (such as NSAIDs and exercise), physical therapy, or no treatment. Other systematic reviews have shown massage to be effective in the short-term for neck pain, but long-term benefits are unclear. Furthermore, massage is frequently perceived by patients as helpful. In a national survey, almost two-thirds (61%) of individuals with neck pain who used both complementary and conventional treatments perceived complementary therapies to be more helpful, whereas only 6% perceived conventional treatments to be better. A Cochrane review rated the overall quality of most massage trials for neck pain as poor, limited by small samples and lack of detail in published reports. However, recent studies by Sherman have set the standard for methodologically rigorous massage trials for chronic neck pain. In one trial, patients (N = 64) randomized to 10 weeks of massage were much more likely to achieve clinically meaningful improvements for neck pain disability compared to patients randomized to a pain self-care book. In a larger trial (N = 228), Sherman's group found that patients who received 60-minute massage sessions, 1 to 3 times weekly were more likely to reach clinically meaningful improvements on neck pain disability and pain intensity compared to patients in the control arm. In a follow up study, designed to evaluate a longer treatment period for massage, neck-related dysfunction and pain severity were assessed at 12 and 26 weeks. Patients who received booster doses of massage had improvements in both dysfunction and pain severity at 12 weeks but nonsignificant changes at 26 weeks.

Massage is theorized to work through a variety of mechanisms to relieve pain. These mechanisms include: 1) increased local blood circulation; 2) improved muscle tone; 3) increased joint flexibility; 4) heightened relaxation response; and 5) changed neuroendocrine and inflammatory status implicated in pain generation and sensitivity.

Despite its safety and potential benefits, the expense associated with massage therapy makes it inaccessible to most Veterans. The national average cost for a massage is approximately $60/hour, but varies significantly by region (urban areas are generally more expensive), setting (e.g., fitness clubs) and therapist training. Massage therapy is primarily an out-of-pocket expense that is rarely covered by health insurance and not affordable to most Veterans. While massage therapy is offered at some VA care settings it is not widely available to Veterans. While one study showed higher costs for massage compared to primary care for low back pain,4 the cost-effectiveness of massage for neck pain has not been examined thoroughly.

Teaching informal care allies to provide massage (care ally -delivered massage) has been most commonly applied and found effective for patients with cancer. care ally -delivered massage has also been tested in the context of pediatric, obstetrical, and long-term care settings for dementia. Kozak et al demonstrated the feasibility of caregiver-given massage in 27 caregiver-Veteran dyads and found significant decreases in pain, stress/anxiety, and fatigue for Veterans with cancer (mean age 63.8 10.2 years). In a larger study, Collinge recruited 97 patient/caregiver dyads (patient mean age 54.7 (SD 11.6), range 24-78 years; caregivers age range 18-82 years) to practice massage. The intervention, compared to attention control, led to decreases in patients' pain, depression, and other cancer-related symptoms. In addition, caregivers benefitted from doing active, hands-on massage. To our knowledge, care ally -delivered massage has not been tested in Veterans with chronic non-cancer pain. We believe this is an important research gap that our study aims to fill. Caregiver-delivered massage is Veteran-centered and has promising preliminary data and implementation potential to be applied across VA since it can address system and Veteran-level barriers.

OBJECTIVE(S):
This study has three objectives:

1)To compare the effects of two massage interventions (care ally-assisted massage and therapist-treated massage) vs. control on pain-related disability

2)To compare the effects of two massage interventions vs. control on secondary outcomes, including pain severity, health-related quality of life, depression, anxiety, and stress

3)To examine the implementation potential of both massage interventions, including facilitators and barriers, treatment and adherence, and intervention costs.

METHODS:
Eligible participants will be those with chronic neck pain for 6 or more months that averages 5 or greater on a 0 to 10 scale. Participants must also have a caregiver (spouse, partner, family member, or friend) willing to learn and provide massage therapy during the study period. Once enrolled, participants will be randomized to one of three study groups:

1) Care ally-assisted massage (CA-M)
2) Therapist-treated massage (TT-M);
3) Waitlist control (WL-C)

The intervention period will last 3 months and outcomes assessments will be completed at baseline, 1, 3, and 6 months. Outcomes will be collected on care allies at baseline and 3 months.

The care ally-assisted massage (CA-M) intervention will consist of 3 treatment components:

1) An in-person training workshop
2) An instructional DVD recording to reinforce concepts taught during the in-
person training session
3) A written treatment manual with illustrations and images to serve as a
reference for participants.

Participants will be asked to engage in at least 3 care ally -assisted massage sessions (30 minutes each) every week at home for the 3-month intervention period. To standardize delivery and facilitate reproducibility of CA-M, the content and general structure of the care ally-delivered massage routine is established and will be taught during the training workshop. The DVD includes a real-time demonstration of the routine for participants to play during applications if desired. The care ally-assisted massage routine is included in the treatment manual. Participants will be asked to record their massage study activity in a provided study log and return log sheets on a monthly basis.

Therapist-treated massage. Participants randomized to the therapist-treated massage (TT-M) arm will receive a standardized Swedish massage protocol tailored to chronic neck pain. Massage therapists will deliver the massage protocol to participants. The massage therapists will use the standard massage techniques applied to the neck region and associated trigger points. Massage sessions will involve a maximum of 60 minutes of hands-on, table time and occur twice a week for 3 months. During the first massage session, the massage therapist will provide an introduction and overview of massage. Thereafter, therapist-treated massage will involve a standardized sequence: 1) hands-on assessment; 2) Swedish massage techniques (e.g. effleurage, p trissage, compression) applied directly to the neck and associated trigger points; and 3) identification and treatment of compensatory patterns. While massage therapists will be permitted to use the range of Swedish massage techniques in the protocol, we will discourage them from providing self-care recommendations about postures, behavioral changes, and sleep.

Waitlist Control Arm. Participants in the control arm will receive check-in calls at months 2 and 4 from study staff and undergo outcome assessments on the same schedule (baseline, 1, 3, and 6 months) as the treatment groups. 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 completion of the final 6 month outcome, participants in the control arm will be eligible to attend a care-ally training session and receive a complementary massage session from a TOMCATT study therapist.

FINDINGS/RESULTS:
No findings have been reported as of 2/2/2018.

IMPACT:
This study tests an innovative approach (care ally -delivered massage) to improve access to a high-demand and promising treatment for chronic neck pain and its associated comorbidities (depression, anxiety, and PTSD). Furthermore, this study tests the capacity of informal caregivers to deliver massage and supports individuals in a novel caregiving role.

Despite the prevalence and disability related to chronic neck pain, research has largely neglected this condition in Veterans. This is of particular concern for VA, given that studies show that chronic pain is associated with lower satisfaction with VA care. Only 28% of Veterans report very good or excellent pain treatment effectiveness. Furthermore, massage is strongly preferred by Veterans and VA facilities are being mandated to reduce reliance on opioids and increase access to complementary approaches since introduction of the Opioid Safety Initiative. It is in this context that the TOMCATT Study is proposed. This project addresses an important VA priority area, pain, consistent with current VA objectives and recommendations, using a novel care delivery approach with strong implementation potential.

This study 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 small studies have shown the effectiveness of massage for pain, massage has not been tested in a large trial or implemented in a systematic in the VA.

The study began recruitment in May 1, 2018.

PUBLICATIONS:
None at this time.


DRA: Musculoskeletal Disorders
DRE: TRL - Applied/Translational, Treatment - Comparative Effectiveness
Keywords: Caregiving, Comparative Effectiveness, Complementary and Alternative Practices, Cost-Effectiveness, Disability, Outcomes - Patient, Pain, Quality of Life
MeSH Terms: none