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Behavioural Intervention

Weighted Blanket for Chronic Pain (WB Trial)

N/A
Recruiting
Led By Laura K Case, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Be older than 18 years old
Must not have
Obstructive sleep apnea if untreated, OR STOP-BANG score in "high-risk" category
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 0, 2, 4, and 6
Awards & highlights

Summary

This trial studies how weighted blankets can reduce chronic pain & sleep disturbance in Veterans, which may improve quality of life.

Who is the study for?
This trial is for Veterans enrolled in VA, both male and female, aged 18 or older with chronic non-cancer musculoskeletal pain diagnosed over at least 6 months and experiencing sleep disturbances. Participants must not have serious mental illness, opioid use disorder, major medical conditions that prevent using a heavy blanket, untreated obstructive sleep apnea, or be using special blankets already.
What is being tested?
The study tests the impact of weighted blankets on pain reduction and sleep quality in Veterans with chronic pain. It randomly assigns participants to use either a light (3-lb) or heavy (15-lb) blanket over six weeks while tracking their pain levels, medication use, and sleep patterns through remote monitoring and smartphone assessments.
What are the potential side effects?
There are minimal expected side effects from using weighted blankets; however individuals may experience discomfort due to the weight of the blanket if they have certain physical limitations or preferences regarding bedding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had chronic pain for over 6 months and my pain level has been at least 3 out of 10.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have untreated sleep apnea or a high STOP-BANG score.
Select...
I do not have any health issues preventing me from safely lifting 15 pounds.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 0, 2, 4, and 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 0, 2, 4, and 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pain impact change
Sleep disturbance change
Secondary study objectives
Daily Sleep Diary
Pain catastrophizing
Pain medication use

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Heavy blanketExperimental Treatment1 Intervention
Wear heavy blanket overnight for 6 weeks
Group II: Light blanketActive Control1 Intervention
Wear light blanket overnight for 6 weeks

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,647 Previous Clinical Trials
3,359,910 Total Patients Enrolled
41 Trials studying Chronic Pain
5,021 Patients Enrolled for Chronic Pain
Laura K Case, PhDPrincipal InvestigatorVA San Diego Healthcare System, San Diego, CA

Media Library

Weighted Blanket (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05963607 — N/A
Chronic Pain Research Study Groups: Heavy blanket, Light blanket
Chronic Pain Clinical Trial 2023: Weighted Blanket Highlights & Side Effects. Trial Name: NCT05963607 — N/A
Weighted Blanket (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05963607 — N/A
~107 spots leftby Apr 2029
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