Chronic Musculoskeletal PainSCIMITARNCT07217821
Stepped-Care Intervention of Music and Imagery to Assess Relief (SCIMITAR) Trial
A study testing Stepped-care in people with Chronic Musculoskeletal Pain and Veterans, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 1 site in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Musculoskeletal Pain, Veterans, Music Therapy
- What is being tested?
- Stepped-care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2023to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Veterans Health Indiana
Indianapolis, Indiana, 46202
Matthew J Bair, MD, 317-988-2058, Matthew.Bair@va.gov
Barry Barker, MS, 765-238-0855, Barry.Barker@va.gov
About this study
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.
Read the 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.
- Conditions
- Chronic Musculoskeletal Pain, Veterans, Music Therapy
- Being tested
- Stepped-care
- Keywords
- chronic pain, veterans, musculoskeletal pain, music therapy, clinical trial
- Medical subject headings
- Chronic Pain, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stepped-careBehavioural
Also called Stepped-care music therapy
Music listening in Step 1 and Music and imagery in step 2
| Study group | Role | What they receive |
|---|---|---|
| Stepped-care | Experimental | Step 1, Music Listening (ML): a music therapist will meet with the Veteran once to identify: musical tastes, preferences and activities. From this meeting a playlist will be compiled for the Veteran to listen to during the 4-week treatment period (step 1). Participants will be asked to listen to music for a minimum of 15 minutes per day at least 4 days per week.
Step 2, Music Imagery (MI): Participants who move to step 2 will receive 8 weekly MI sessions over 8-10 weeks. The 8-session protocol has two stages. Stage 1 (sessions 1-4) is focused on learning to use music and imagery for self-regulation. Stage 2 (sessions 5-8) focuses on identifying and deepening inner resources and learning how to utilize them for self-care. Imagery is used during both stages, but becomes a central focus during Stage 2. Receives: Behavioral: Stepped-care |
| Waitlist control | No intervention | Wait-list Control: Following the 6-month outcome assessment, participants in the wait-list control arm will be offered abbreviated treatment of 3 sessions with a music therapist (one session to introduce ML with the option to receive 2 additional MI sessions). Participants will also be offered a referral to music therapy services. Participants in the wait-list control arm (and stepped-care group) may receive other pain treatments such as analgesics and non-pharmacological options (e.g., physical therapy) for their chronic MSK pain. The wait-list control arm will provide an untreated comparison to stepped-care and music therapy to assess outcomes during the same trial period, while still offering participants music therapy at study end if desired. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Pain Inventory - Pain Interference
Assesses how pain interferes with 7 activities of daily living
Measured: baseline, 1, 3, and 6 months
Secondary outcomes (8)
Numeric rating scale
Assess pain severity
Measured: baseline, 1, 3, and 6 months
Patient Global Impression of Change
Assess treatment response
Measured: 1, 3, and 6 months
PROMIS Sleep Scale
Assesses quality of sleep
Measured: baseline, 1, 3, and 6 months
GAD-7 Anxiety
Assesses anxiety symptoms
Measured: baseline, 1, 3, and 6 months
PHQ-9 Depression
Assesses depression symptoms
Measured: baseline, 1, 3, and 6 months
PC PTSD Screen
Screens for PTSD
Measured: baseline, 1, 3, and 6 months
Perceived Stress Scale
Assesses stress
Measured: baseline, 1, 3, and 6 months
Mood regulation (B-MMR)
Assesses ability to regulate mood
Measured: baseline, 1, 3, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2025
- Study start30 Aug 2023
- Primary completion31 Jan 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Musculoskeletal PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana Institute for Medical Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07217821
- Sponsor's protocol ID
- 1903704-22-C-22
- Other IDs
- 66974
- Acronym
- SCIMITAR
- Status last verified
- Sep 2025
- First submitted
- 15 Oct 2025
- Last updated
- 16 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will discuss with potential collaborators on a case-by-case basis.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stepped-Care Intervention of Music and Imagery to Assess Relief (SCIMITAR) Trial
- ClinicalTrials.gov ID
- NCT07217821
- Acronym / sponsor ID
- SCIMITAR / 1903704-22-C-22
- Conditions
- Chronic Musculoskeletal Pain, Veterans, Music Therapy
- Keywords
- chronic pain, veterans, musculoskeletal pain, music therapy, clinical trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military MedicineUniversity, hospital or other
- Collaborators
- Indiana Institute for Medical Research
- Study start
- 30 Aug 2023 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 16 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Stepped-care | Experimental | Behavioral: Stepped-careStep 1, Music Listening (ML): a music therapist will meet with the Veteran once to identify: musical tastes, preferences and activities. From this meeting a playlist will be compiled for the Veteran to listen to during the 4-week treatment period (step 1). Participants will be asked to listen to music for a minimum of 15 minutes per day at least 4 days per week. Step 2, Music Imagery (MI): Participants who move to step 2 will receive 8 weekly MI sessions over 8-10 weeks. The 8-session protocol has two stages. Stage 1 (sessions 1-4) is focused on learning to use music and imagery for self-regulation. Stage 2 (sessions 5-8) focuses on identifying and deepening inner resources and learning how to utilize them for self-care. Imagery is used during both stages, but becomes a central focus during Stage 2. |
| Waitlist control | No intervention | –Wait-list Control: Following the 6-month outcome assessment, participants in the wait-list control arm will be offered abbreviated treatment of 3 sessions with a music therapist (one session to introduce ML with the option to receive 2 additional MI sessions). Participants will also be offered a referral to music therapy services. Participants in the wait-list control arm (and stepped-care group) may receive other pain treatments such as analgesics and non-pharmacological options (e.g., physical therapy) for their chronic MSK pain. The wait-list control arm will provide an untreated comparison to stepped-care and music therapy to assess outcomes during the same trial period, while still offering participants music therapy at study end if desired. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stepped-careAlso: Stepped-care music therapyMusic listening in Step 1 and Music and imagery in step 2 | Behavioural | Stepped-care |
Primary outcome
Brief Pain Inventory - Pain Interference
Time frame: baseline, 1, 3, and 6 months
Assesses how pain interferes with 7 activities of daily living
8 secondary outcomes
Numeric rating scale
Time frame: baseline, 1, 3, and 6 months
Patient Global Impression of Change
Time frame: 1, 3, and 6 months
PROMIS Sleep Scale
Time frame: baseline, 1, 3, and 6 months
GAD-7 Anxiety
Time frame: baseline, 1, 3, and 6 months
PHQ-9 Depression
Time frame: baseline, 1, 3, and 6 months
PC PTSD Screen
Time frame: baseline, 1, 3, and 6 months
Perceived Stress Scale
Time frame: baseline, 1, 3, and 6 months
Mood regulation (B-MMR)
Time frame: baseline, 1, 3, and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2025.
- Individual participant dataSharing planned: Undecided. We will discuss with potential collaborators on a case-by-case basis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stepped-care in people with Chronic Musculoskeletal Pain and Veterans, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara M Kass, MD (240-463-2600, skass@hjf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Pain Inventory - Pain Interference (time frame: baseline, 1, 3, and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2025; AzTrials last refreshed its copy on 8 Nov 2026.