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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 : July 25, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE March 6, 2017
First Posted Date  ICMJE April 4, 2017
Last Update Posted Date July 25, 2019
Actual Study Start Date  ICMJE May 1, 2017
Estimated Primary Completion Date October 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2017)
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."
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03100539 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2017)
  • 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.
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial Outcomes for Massage: Caregiver-Assisted vs. Therapist-Treated
Official Title  ICMJE Trial Outcomes for Massage: Caregiver-Assisted vs. Therapist-Treated (TOMCATT)
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 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.
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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Neck Pain
  • Chronic Pain
  • Pain
  • Arthritis
  • Musculoskeletal Pain
  • Osteoarthritis
Intervention  ICMJE
  • Other: Care giver treatment

    The caregiver -assisted massage (CG-M) intervention will consist of 3 treatment components:

    • An in-person training workshop
    • An instructional DVD recording to reinforce concepts taught during the in-person training session
    • 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 giver-assisted massage sessions (30 minutes each) every week at home for the 3-month intervention period. To standardize delivery and facilitate reproducibility of CG-M, the content and general structure of the caregiver-delivered massage routine is established and will be taught during the training workshop

    Other Name: CA-M
  • 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
Study Arms  ICMJE
  • Active Comparator: Care giver treatment arm (CG-M)

    The caregiver -assisted massage (CG-M) intervention will consist of 3 treatment components:

    • An in-person training workshop
    • An instructional DVD recording to reinforce concepts taught during the in-person training session
    • 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 giver-assisted massage sessions (30 minutes each) every week at home for the 3-month intervention period. To standardize delivery and facilitate reproducibility of CG-M, the content and general structure of the caregiver-delivered massage routine is established and will be taught during the training workshop.
    Intervention: Other: Care giver 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.
    Intervention: Other: Therapist treated massage
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 28, 2017)
468
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 30, 2021
Estimated Primary Completion Date October 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Matthew Kline, BS (317) 988-3838 matthew.Kline@va.gov
Contact: Erica D Evans, BA (317) 988-3476 erica.evans2@va.gov
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03100539
Other Study ID Numbers  ICMJE IIR 15-333
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Matthew J. Bair, MD MS Richard L. Roudebush VA Medical Center, Indianapolis, IN
PRS Account VA Office of Research and Development
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP