NCT03100539|CompletedResultsDMC
Trial Outcomes for Massage: Caregiver-Assisted vs. Therapist-Treated
TOMCATT
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Sponsor study identifier
interventional
395
1 country
1
Study Start
May 1, 2017
Actual (reported)Primary Completion
February 28, 2023
Actual (reported)Study Completion
February 28, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 28, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 6, 2017
Actual (reported)April 4, 2017
Actual (reported)May 1, 2017
Actual (reported)February 28, 2023
Actual (reported)February 28, 2023
Actual (reported)September 20, 2024
Actual (reported)Neck Disability Index
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."
Baseline
Neck Disability Index
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."
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.
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.
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.
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, 46202-2803, United States
Munk N, Daggy JK, Evans E, Kline M, Slaven JE, Laws B, Foote T, Matthias MS, Bair MJ. Therapist-Delivered Versus Care Ally-Assisted Massage for Veterans With Chronic Neck Pain: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Sep 27;11(9):e38950. doi: 10.2196/38950.
Munk N, Daggy JK, Slaven JE, Foote T, Garner M, Evans E, Laws BV, Matthias MS, Bair MJ. Therapist delivered massage for Veterans with chronic neck pain: a randomized control trial. Pain Med. 2026 Feb 1;27(2):160-169. doi: 10.1093/pm/pnaf118.
Matthew J. Bair, MD MS
Richard L. Roudebush VA Medical Center, Indianapolis, IN
395 participants (actual enrollment reported by the registry).
First Submitted
March 6, 2017
First Posted
April 4, 2017
Study Start
May 1, 2017
Actual (reported)Acupuncture Approaches for Chronic Pain
1 Month
Neck Disability Index
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."
3 Month
Neck Disability Index
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."
6 Month
Brief Pain Inventory (BPI)
Baseline
Medical Outcomes Study Veterans RAND 36 Item Health Survey (VR-36) (Modified From Medical Outcomes Study SF-36)
Baseline
Brief Pain Inventory (BPI)
1 Month
Brief Pain Inventory (BPI)
3 Month
Brief Pain Inventory (BPI)
6 Month
CA-M consisted of in-person training for veteran/care-ally dyads to learn a standardized 30-minue massage routine, instructional DVD, and printed treatment manual. Participants were to complete three care ally-assisted massage sessions weekly for 12-weeks.
CA-M consisted of in-person training for veteran/care-ally dyads to learn a standardized 30-minue massage routine, instructional DVD, and printed treatment manual. Participants were to complete three care ally-assisted massage sessions weekly for 12-weeks.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Munk N, Daggy JK, Slaven JE, Evans E, Foote T, Laws BV, Matthias MS, Bair MJ. Care ally-assisted massage for Veterans with chronic neck pain: TOMCATT results. Contemp Clin Trials. 2024 Jul;142:107561. doi: 10.1016/j.cct.2024.107561. Epub 2024 May 3.
Primary Completion
February 28, 2023
Actual (reported)Study Completion
February 28, 2023
Actual (reported)Last Updated
September 20, 2024
Results First Posted
September 20, 2024
Record last verified: 2024-08
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Source: ClinicalTrials.gov.
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