Status:
RECRUITING
RCT of a Weighted Blanket to Reduce Pain in Veterans With Chronic Pain
Lead Sponsor:
VA Office of Research and Development
Conditions:
Chronic Pain
Sleep Disturbance
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Chronic pain is a major health concern for returning Veterans and is associated with decreases in quality of life. In addition, chronic pain is often accompanied by significant disturbance in sleep. S...
Detailed Description
Chronic pain is a major health concern for returning Veterans15 and is associated with decreases in quality of life16, increased opioid use/misuse and self-injury17,18, and significant emotional toll ...
Eligibility Criteria
Inclusion
- The inclusion/exclusion criteria are designed to be as inclusive as possible and to reflect the heterogeneity of "real-world" Veterans referred to usual care, to maximize generalizability:
- VA-enrolled
- All genders, ages 18 and older
- chronic non-cancer musculoskeletal pain diagnosis on 2 clinical visits for at least 6 months (ICD codes for chronic pain), and a score of 3 on the numerical pain rating scale from 0-10 over the past week
- sleep disturbance measured by a score \>= 11 on the ISI.
Exclusion
- Exclusion criteria: Exclusion criteria include only those factors that contraindicate usual treatment for chronic pain, that prevent the Veteran from benefiting from study treatments, or that may interfere with the mechanisms under study:
- Serious or untreated mental illness (e.g., psychosis; PTSD will not be excluded),
- other psychosocial instability (e.g., homelessness), or
- suicidal/homicidal ideation/prior attempt within the past 3 years by the Mini-International Neuropsychiatric Interview (MINI)19;
- evidence of opioid use disorder by chart review, or a Current Opioid Misuse Measure (COMM20) score of 9 or both;
- major medical conditions or medical counterindications to use of a 15-lb WB (e.g., self-reported or documented current pregnancy;
- claustrophobia;
- spinal cord injury;
- inability to safely lift 15lb);
- obstructive sleep apnea if untreated, OR STOP-BANG score in "high-risk" category; and
- currently sleeping with a special blanket (such as weighted or cooling blanket).
- Those receiving mental health or other pain treatment will be excluded if there are changes to treatment (either therapy or medications) in the 3 months prior to enrollment or anticipated during the 2-month trial (self-report, confirmed as possible in electronic health record).
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2029
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT05963607
Start Date
August 1 2024
End Date
September 30 2029
Last Update
July 30 2025
Active Locations (3)
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1
VA San Diego Healthcare System, San Diego, CA
San Diego, California, United States, 92161-0002
2
VA San Diego Healthcare System, San Diego, CA
San Diego, California, United States, 92161-0002
3
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, United States, 94121-1563