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Behavioural Intervention
Weighted Blanket for Chronic Pain (WB Trial)
Phase 2
Waitlist Available
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 0, 2, 4, and 6
Awards & highlights
WB Trial 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.Check my eligibility
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.See study design
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.
WB Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had chronic pain for over 6 months and my pain level has been at least 3 out of 10.
WB Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weeks 0, 2, 4, and 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 0, 2, 4, and 6
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pain impact change
Sleep disturbance change
Secondary outcome measures
Daily Sleep Diary
Pain catastrophizing
Pain medication use
WB 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
1,609 Previous Clinical Trials
3,306,293 Total Patients Enrolled
39 Trials studying Chronic Pain
4,597 Patients Enrolled for Chronic Pain
Laura K Case, PhDPrincipal InvestigatorVA San Diego Healthcare System, San Diego, CA
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My mental health or pain treatment has been stable for the last 3 months and will remain so during the trial.I have untreated sleep apnea or a high STOP-BANG score.You are currently using a special blanket like a heavy or cooling blanket while sleeping.I am 18 years old or older.You have a serious untreated mental illness or unstable living situation, or have had thoughts of harming yourself or someone else in the past 3 years.You have a sleep problem that is severe, measured by a score of 11 or higher on the ISI (Insomnia Severity Index).I have had chronic pain for over 6 months and my pain level has been at least 3 out of 10.Your medical records show that you have a problem with using opioid drugs, or you scored 9 or more on a test that shows you may have a problem with using opioid drugs.I do not have any health issues preventing me from safely lifting 15 pounds.
Research Study Groups:
This trial has the following groups:- Group 1: Heavy blanket
- Group 2: Light blanket
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent can utilization of Heavy blanket be detrimental to human health?
"There has been some evidence of Heavy blanket's safety, which earned it a score of 2 out of 3. However, efficacy is yet to be proven in clinical trials."
Answered by AI
Is this trial actively seeking participants?
"Clinicaltrials.gov confirms that this study, which was initially posted on April 1st 2024 and last updated in July of 2023, is no longer actively recruiting patients. Nonetheless, there are 697 other clinical trials around the world seeking candidates now."
Answered by AI
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