RCT of a Weighted Blanket to Reduce Pain in Veterans With Chronic Pain

NCT05963607 | Recruiting

• 2 other identifiers: NURP-005-22FI01CX002591
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Pain; Sleep Disturbance

Keywords

chronic pain; sleep; weighted blanket; mood

Outcome Measures

Primary Outcomes (2)

• Pain impact change

  Pain impact (severity and interference) will be measured by the Pain, Enjoyment of Life, and General Activity (PEG) Scale

  Weeks 0, 2, 4, and 6

• Sleep disturbance change

  Sleep disturbance will be measured by the Insomnia Severity Index (ISI)

  Weeks 0, 2, 4, and 6

Secondary Outcomes (3)

• Pain catastrophizing

  Weeks 0, 2, 4, and 6

• Pain medication use

  Weeks 0, 2, 4, and 6

• Daily Sleep Diary

  Weeks 0, 2, 4, and 6

Study Arms (2)

Heavy blanket

EXPERIMENTAL

Wear heavy blanket overnight for 6 weeks

Other: Weighted blanket

Light blanket

ACTIVE COMPARATOR

Wear light blanket overnight for 6 weeks

Other: Weighted blanket

Interventions

Weighted blanket OTHER

A blanket sewn with extra weight in it.

Heavy blanket; Light blanket

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

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

MeSH Terms

Conditions

Chronic Pain; Parasomnias

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Irina Strigo, PhD

  San Francisco VA Medical Center, San Francisco, CA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Irina Strigo, PhD

CONTACT

(415) 221-4810; irina.strigo@va.gov

Matthew R Herbert, PhD

CONTACT

(858) 642-3944; matthew.herbert2@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be masked to study group to the extent possible (blanket weights are self-evident). Data will be collected online/remotely with no interaction from the study team except for study reminders or technical assistance.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Randomized controlled study with two study arms.

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: July 27, 2023
• Study Start: August 1, 2024
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): September 30, 2029
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)