RCT of a Weighted Blanket to Reduce Pain in Veterans With Chronic Pain
- NCT ID
- NCT05963607
- Registry status
- Recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Sponsor
- VA Office of Research and Development
- Conditions
- Chronic Pain, Sleep Disturbance
Overview
ClinicalTrials.gov lists this study as Recruiting.
Enrollment: 160 participants (Estimated).
What is being studied
- Other: Weighted blanket
Who may be eligible
- Ages
- 18 Years to no maximum
- Sex
- All
- Healthy volunteers accepted
- No
ClinicalTrials.gov lists the following eligibility criteria.
Inclusion Criteria:
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 Criteria:
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).
Study locations
2 study locations are listed.
Recruiting site status is explicitly provided for 2 locations; 2 are listed as Recruiting.
Countries: United States
- California, United States: 2
Sample of listed locations
- VA San Diego Healthcare System, San Diego, CA — San Diego, California, 92161-0002, United States — Recruiting
- San Francisco VA Medical Center, San Francisco, CA — San Francisco, California, 94121-1563, United States — Recruiting
Study details
- Start date
- August 1, 2024
- Primary completion date
- April 1, 2029
- Completion date
- September 30, 2029
- First posted
- July 27, 2023
Source and update information
- Source
- ClinicalTrials.gov
- NCT ID
- NCT05963607
- Registry last updated
- August 26, 2026
- QualifiedStudies registry data refreshed
- October 2, 2026
- QualifiedStudies record fetched
- October 2, 2026
View NCT05963607 on ClinicalTrials.gov
Trial information can change. Confirm current study details with the study team or the registry.
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