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NCT03100539 · ClinicalTrials.gov registry record · NA
Trial Outcomes for Massage: Caregiver-Assisted vs. Therapist-Treated
A NA study of Pain and Chronic Pain, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 395
- Enrollment target
- 1
- Study location
NCT03100539: Completed NA study of Pain and Chronic Pain, sponsored by VA Office of Research and Development.
NCT03100539 is a NA study of Pain and Chronic Pain that has completed, run by VA Office of Research and Development. The registered enrollment target is 395 participants, above the 303-participant average among 374 other Pain trials with a reported enrollment target (30% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03100539, a NA study of Pain and Chronic Pain, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 395 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- OTHER Therapist treated massage
- OTHER Care ally assisted massage
Study Locations (1)
Indiana
- Richard L. Roudebush VA Medical Center, Indianapolis, IN - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 395 participants |
| Start Date | 2017-05-01 |
| Est. Completion | 2023-02-28 |
| Phase | NA |
What the finished NCT03100539 record still lists
NCT03100539 is an interventional study that assigns participants to a tested intervention. The registered 395 participants enrollment target is mid-sized for trials with a published cap, above the 303-participant average among 374 other Pain trials with a reported enrollment target (30% higher).
The record links to 6 conditions, with Pain appearing as the primary indexed condition, and to 2 interventions - of which Therapist treated massage is the first listed.
NCT03100539 reports a single indexed study location in Indiana.
Frequently Asked Questions
What is clinical trial NCT03100539 about?
NCT03100539 is a clinical study titled "Trial Outcomes for Massage: Caregiver-Assisted vs. Therapist-Treated". 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 prio...
What is the current status of trial NCT03100539?
This trial is currently completed. It is a NA study. The enrollment target is 395 participants. The study started on 2017-05-01. Estimated completion is 2023-02-28.
What conditions does trial NCT03100539 study?
This clinical trial studies the following conditions: Pain, Chronic Pain, Osteoarthritis, Arthritis, Musculoskeletal Pain.
What interventions are being tested in trial NCT03100539?
The interventions under investigation include: Therapist treated massage (OTHER), Care ally assisted massage (OTHER).
Who is sponsoring clinical trial NCT03100539?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03100539 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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