Chronic Musculoskeletal Pain, Music Therapy, Veterans
Conditions
Keywords
chronic pain, veterans, musculoskeletal pain, music therapy, clinical trial
Brief summary
Th Stepped-Care Intervention of Music and Imagery to Assess Relief (SCIMITAR) Trial. SCIMITAR builds on our pilot study, the Feasibility and Acceptability of Music Imagery and Listening Interventions for Analgesia (FAMILIA), which demonstrated that telehealth delivery of music listening (ML) and music imagery (MI) interventions is feasible and acceptable to Veterans with chronic musculoskeletal pain. SCIMITAR leverages what we learned from FAMILIA into a fully powered trial, harnessing the benefits of sequential ML and MI into a stepped-care, music therapy intervention via telehealth for Veterans needing relief from pain.
Detailed description
More than 100 million Americans have chronic pain. Chronic pain affects 40%-70% of Veterans and is a leading cause of disability, with a substantial negative impact on millions of veterans' lives. Chronic pain is frequently accompanied by psychological comorbidity that adds to patient suffering and complicates treatment. Veterans with pain and PTSD demonstrate greater pain, depression, and healthcare utilization, and patients with comorbid pain and depression have worse outcomes than patients with pain or depression alone. Musculoskeletal (MSK) pain conditions are widespread, accounting for two-thirds of all clinical visits for pain. There is a pressing need to provide effective, non-pharmacological treatment to Veterans with chronic MSK pain. To improve pain-related outcomes, the VA recommends an integrative and stepped-care approach to pain management, including non-pharmacological treatments. The SCIMITAR Trial is a 2-arm, parallel group, randomized controlled trial. After providing informed consent and completing their baseline assessment, participants will be randomized in a 1:1 allocation ratio to a stepped-care music intervention or waitlist control. The study population will include 180 Veterans with chronic MSK pain.
Interventions
BEHAVIORALStepped-care
Music listening in Step 1 and Music and imagery in step 2
Sponsors
Indiana Institute for Medical Research
Henry M. Jackson Foundation for the Advancement of Military Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessors are blinded to study arm allocation
Intervention model description
The SCIMITAR Trial is a 2-arm, parallel-group, randomized controlled trial. Participants will be randomized in a 1:1 allocation ratio to a stepped-care music intervention or a waitlist control.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* musculoskeletal pain in the low back, cervical spine, or extremities (hips, knees, or shoulders) for ≥ 3 months * at least moderate pain severity, defined as a PEG score ≥ 4 on a 0 (no pain) to 10 (worst pain) * access to computer, tablet, or smartphone * ability to pass a technology assessment
Exclusion criteria
* Past month hospitalization for medical or psychiatric illness * housing insecurity * suicidal ideation with current intent/plan * hearing or cognitive impairment that may interfere with music listening or abstract thinking needed for imagery work * currently receiving music therapy services
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brief Pain Inventory - Pain Interference | baseline, 1, 3, and 6 months | Assesses how pain interferes with 7 activities of daily living |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Global Impression of Change | 1, 3, and 6 months | Assess treatment response |
| PROMIS Sleep Scale | baseline, 1, 3, and 6 months | Assesses quality of sleep |
| GAD-7 Anxiety | baseline, 1, 3, and 6 months | Assesses anxiety symptoms |
| Numeric rating scale | baseline, 1, 3, and 6 months | Assess pain severity |
| PC PTSD Screen | baseline, 1, 3, and 6 months | Screens for PTSD |
| Perceived Stress Scale | baseline, 1, 3, and 6 months | Assesses stress |
| Mood regulation (B-MMR) | baseline, 1, 3, and 6 months | Assesses ability to regulate mood |
| PHQ-9 Depression | baseline, 1, 3, and 6 months | Assesses depression symptoms |
Countries
United States
Contacts
Primary ContactSara M Kass, MD
Backup ContactMarianne Spevak, BSHS
Outcome results
None listed