NCT05963607 RCT of a Weighted Blanket to Reduce Pain in Veterans With Chronic Pain
| NCT ID | NCT05963607 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Office of Research and Development |
| Condition | Chronic Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2029-04-01 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 160 participants in total. It began in 2024-08-01 with a primary completion date of 2029-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. Sensory interventions may offer effective, low-cost complementary tools for chronic pain and sleep disturbance in Veterans. Weighted Blankets (WB)- blankets sewn with weighted material inside to provide widespread pressure to the body- are a low-cost wellness product used for anxiety and sleep. WBs have demonstrated large reductions in insomnia, and the investigators have also shown that they can reduce the severity of chronic pain. However, effects and mechanisms of longer WB use have not been examined in individuals with pain and sleep disturbance. The investigators therefore propose a randomized controlled trial examining the effects of WBs on pain and sleep quality in Veterans. the investigators will recruit Veterans with chronic pain and sleep disturbance from the VA San Diego Healthcare System (VASDHS) and VA San Francisco Healthcare System (VASFHS) and randomize 160 Veterans to receive either a light (3-lb; N = 80) or heavy (15-lb; N = 80) blanket. The investigators will remotely collect measures of pain (primary), pain catastrophizing, and pain medication use, as well as sleep disturbance (primary) and sleep efficiency and total sleep time over 6 weeks of overnight home use of the assigned blanket. The investigators will also explore physiological effects of WBs on sleep quality using actigraphy (exploratory) in VASDHS participants. Ecological momentary assessment (EMA) methods will be deployed via smartphone to capture study adherence.
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).
Contact & Investigator
Irina Strigo, PhD
PRINCIPAL INVESTIGATOR
San Francisco VA Medical Center, San Francisco, CA
Frequently Asked Questions
Who can join the NCT05963607 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05963607 currently recruiting?
Yes, NCT05963607 is actively recruiting participants. Contact the research team at irina.strigo@va.gov for enrollment information.
Where is the NCT05963607 trial being conducted?
This trial is being conducted at San Diego, United States, San Francisco, United States.
Who is sponsoring the NCT05963607 clinical trial?
NCT05963607 is sponsored by VA Office of Research and Development. The principal investigator is Irina Strigo, PhD at San Francisco VA Medical Center, San Francisco, CA. The trial plans to enroll 160 participants.
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