Using weighted blankets to help veterans with chronic pain and sleep issues

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of weighted blankets on chronic pain and sleep quality in veterans. It aims to recruit veterans suffering from chronic non-cancer musculoskeletal pain and sleep disturbances, assessing the potential benefits of this low-cost sensory intervention. Participants will use weighted blankets over a specified period, and the study will evaluate changes in pain severity and sleep quality. The research is designed to provide insights into the effectiveness of weighted blankets as a complementary tool for managing chronic pain and improving sleep among veterans.

Why it matters

Who can join: the full rules

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).

Where it's running

• VA San Diego Healthcare System, San Diego, CA
  San Diego, California, United States Recruiting
• San Francisco VA Medical Center, San Francisco, CA
  San Francisco, California, United States Recruiting

Study contacts

• Principal investigator: Irina Strigo, PhD — San Francisco VA Medical Center, San Francisco, CA
• Study coordinator: Irina Strigo, PhD
• Email: irina.strigo@va.gov
• Phone: (415) 221-4810

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.