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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