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

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ClinicalTrials.gov Identifier: NCT03100539
Recruitment Status : Recruiting
First Posted : April 4, 2017
Last Update Posted : May 26, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Neck Pain Chronic Pain Pain Arthritis Musculoskeletal Pain Osteoarthritis Other: Therapist treated massage Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 468 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Trial Outcomes for Massage: Caregiver-Assisted vs. Therapist-Treated (TOMCATT)
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : October 30, 2020
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Therapist treated massage (TT-M)
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
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 Name: TT-M

No Intervention: Wait list control (WL-C)
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.



Primary Outcome Measures :
  1. Neck Disability index [ Time Frame: 3 month ]
    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."


Secondary Outcome Measures :
  1. Brief pain inventory (BPI) [ Time Frame: baseline, 1,3 and 6 month outcomes ]
    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.

  2. Patient Reported Outcomes Measurement Information System (PROMIS) pain [ Time Frame: baseline, 1,3 and 6 month outcomes ]
    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

  3. Medical outcomes study Veterans RAND 36 Item Health Survey (VR-36) (modified from Medical Outcomes Study SF-36) [ Time Frame: baseline, 1,3 and 6 month outcomes ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 15)

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03100539


Contacts
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Contact: Matthew Kline, BS MBA (317) 988-3838 matthew.Kline@va.gov
Contact: Erica D Evans, BA (317) 988-3476 erica.evans2@va.gov

Locations
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United States, Indiana
Richard L. Roudebush VA Medical Center, Indianapolis, IN Recruiting
Indianapolis, Indiana, United States, 46202-2884
Contact: Linda A Collins, BS CRA    (317) 988-2722    linda.collins4@va.gov   
Contact: Jennifer Myers, MSW    (317) 988-4407    Jennifer.Myers@va.gov   
Sub-Investigator: Karen J Sherman, PhD MPH         
Sub-Investigator: Marianne Sassi Matthias, PhD MS BA         
Principal Investigator: Matthew J. Bair, MD MS         
Sub-Investigator: Sonya Nicole Munk, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Matthew J. Bair, MD MS Richard L. Roudebush VA Medical Center, Indianapolis, IN
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03100539    
Other Study ID Numbers: IIR 15-333
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: May 26, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
Massage
Fascia
Additional relevant MeSH terms:
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Musculoskeletal Pain
Chronic Pain
Neck Pain
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Muscular Diseases