N/A N=392 Randomized Single-blind Treatment

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

Neck Pain · Chronic Pain · Pain · Arthritis · Musculoskeletal Pain

Bottom Line

View on ClinicalTrials.gov: NCT03100539 ↗

Enrolled (actual)

392

Serious AEs

4.9%

Results posted

Sep 2024

Primary outcome: Primary: Neck Disability Index — 20.3; 20.5; 18.3 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Therapist treated massage (Other); Care ally assisted massage (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: VA Office of Research and Development
Primary completion: Feb 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Neck Disability Index	18.5; 21.6; 14.9	—
PRIMARY Neck Disability Index	18.5; 21.6; 14.9	—
PRIMARY Neck Disability Index	18.5; 21.6; 14.9	—
PRIMARY Neck Disability Index	18.5; 21.6; 14.9	—
SECONDARY Brief Pain Inventory (BPI)	4.7; 5.7; 4.5	—
SECONDARY Medical Outcomes Study Veterans RAND 36 Item Health Survey (VR-36) (Modified From Medical Outcomes Study SF-36)	45.8; 43.4; 49.7	—
SECONDARY Brief Pain Inventory (BPI)	4.7; 5.7; 4.5	—
SECONDARY Brief Pain Inventory (BPI)	4.7; 5.7; 4.5	—
SECONDARY Brief Pain Inventory (BPI)	4.7; 5.7; 4.5	—
SECONDARY Medical Outcomes Study Veterans RAND 36 Item Health Survey (VR-36) (Modified From Medical Outcomes Study SF-36)	45.8; 43.4; 49.7	—
SECONDARY Medical Outcomes Study Veterans RAND 36 Item Health Survey (VR-36) (Modified From Medical Outcomes Study SF-36)	45.8; 43.4; 49.7	—
SECONDARY Medical Outcomes Study Veterans RAND 36 Item Health Survey (VR-36) (Modified From Medical Outcomes Study SF-36)	45.8; 43.4; 49.7	—

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.

Eligibility 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 10)

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03100539). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.