RCT of a Weighted Blanket to Reduce Pain in Veterans With Chronic Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development
About this trial
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
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Weighted blanket
Other interventionA blanket sewn with extra weight in it.
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: Heavy blanketExperimental treatment 1 intervention
Group B: Light blanketActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pain impact change
Pain impact (severity and interference) will be measured by the Pain, Enjoyment of Life, and General Activity (PEG) Scale
Time frame
Weeks 0, 2, 4, and 62
Sleep disturbance change
Sleep disturbance will be measured by the Insomnia Severity Index (ISI)
Time frame
Weeks 0, 2, 4, and 6Secondary outcomes
1
Pain catastrophizing
Pain catastrophizing will be measured by the Pain Catastrophizing Scale (PCS).
Time frame
Weeks 0, 2, 4, and 62
Pain medication use
Participants will be asked to self report their current pain medication use including prescribed pain medications, dose, and frequency. Prescriptions will be verified with VA electronic health records. Change in pain medications will be quantified as a percent in daily dose from baseline (if multiple pain medications are prescribed, percent change will be averaged across all pain medications). Opioids will be standardized in morphine milligram equivalents.
Time frame
Weeks 0, 2, 4, and 63
Daily Sleep Diary
This 12-item scale measures sleep efficiency and total sleep time.
Time frame
Weeks 0, 2, 4, and 6Sponsors and contacts
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Source ClinicalTrials.gov