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Therapist treated massage for Osteoarthritis (TOMCATT Trial)
N/A
Waitlist Available
Led By Matthew J. Bair, MD MS
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Chronic neck pain for 6 months or longer
Neck pain of at least moderate severity (NDI score greater than or equal to 10)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1,3 and 6 month outcomes
Awards & highlights
TOMCATT Trial Summary
This trial aims to study whether massage is an effective, safe, affordable, and accessible treatment for Veterans with chronic neck pain.
Eligible Conditions
- Osteoarthritis
- Chronic Pain
- Musculoskeletal Pain
- Arthritis
- Pain
- Neck Pain
TOMCATT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTOMCATT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 1,3 and 6 month outcomes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1,3 and 6 month outcomes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Neck
Secondary outcome measures
Brief pain inventory (BPI)
Medical outcomes study Veterans RAND 36 Item Health Survey (VR-36) (modified from Medical Outcomes Study SF-36)
Pain
TOMCATT Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Therapist treated massage (TT-M)Experimental Treatment1 Intervention
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.
Group II: Wait list control (WL-C)Active Control1 Intervention
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.
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,605 Previous Clinical Trials
3,305,201 Total Patients Enrolled
21 Trials studying Osteoarthritis
3,146 Patients Enrolled for Osteoarthritis
Matthew J. Bair, MD MSPrincipal InvestigatorRichard L. Roudebush VA Medical Center, Indianapolis, IN
4 Previous Clinical Trials
3,288 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are volunteers still needed for this trial?
"Affirmative. According to the information published on clinicaltrials.gov, this research project is actively seeking participants, with 366 subjects being sought at a single site since its inception on May 1st 2017 and last update on September 7th 2022."
Answered by AI
How many individuals are currently engaged in this research endeavor?
"Affirmative; records hosted on clinicaltrials.gov state that this trial is currently searching for participants. It was initiated in May 2017 and most recently updated in September 2022, aiming to enroll 366 patients from a single centre."
Answered by AI
Who else is applying?
What state do they live in?
Indiana
What site did they apply to?
Richard L. Roudebush VA Medical Center, Indianapolis, IN
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
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