Trial Outcomes for Massage: Caregiver-Assisted vs. Therapist-Treated
| Status: | Recruiting |
|---|---|
| Conditions: | Arthritis, Arthritis, Arthritis, Chronic Pain, Chronic Pain, Chronic Pain, Osteoarthritis (OA), Orthopedic, Pain |
| Therapuetic Areas: | Musculoskeletal, Rheumatology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/17/2019 |
| Start Date: | May 1, 2017 |
| End Date: | March 30, 2021 |
| Contact: | Matthew Kline, BS |
| Email: | matthew.Kline@va.gov |
| Phone: | (317) 988-3838 |
Trial Outcomes for Massage: Caregiver-Assisted vs. Therapist-Treated (TOMCATT)
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 two different 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.
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 two different 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.
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: This 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. The investigators 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, the investigators 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, 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.
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: This 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. The investigators 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, the investigators 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, 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.
Inclusion Criteria:
- Chronic neck pain for 6 months or longer
- Neck pain of at least moderate severity (NDI score greater than or equal to 15)
- Have a caregiver who is willing to learn and provide massage therapy during the study
period
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
We found this trial at
1
site
Indianapolis, Indiana 46202
Phone: (317) 988-2722
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