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New treatment option for Chronic Pain
Official title RCT of a Weighted Blanket to Reduce Pain in Veterans With Chronic Pain
ClinicalTrials.gov ID: NCT05963607
What this study is testing
- What it's testing
- 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.
- Time commitment: about 6 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The inclusion/
You likely can't join if
- are designed to be as inclusive as possible and to reflect the heterogeneity of "real-world" Veterans referred to usual care, to maximize...
- 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...
- sleep disturbance measured by a score \>= 11 on the ISI. Exclusion Criteria: Exclusion criteria: Exclusion criteria include only those factors that...
- Serious or untreated mental illness (e.g., psychosis; PTSD will not be excluded),
See the full eligibility criteria
- The inclusion/
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- San Diego, California, United States
- San Francisco, California, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Diego, California, United States; San Francisco, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.