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A Single-Arm Pilot Study Investigating Weighted Blanket Use for Chronic Pain

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Chronic pain is a common condition that can affect sleep, daily functioning, and overall quality of life. Many individuals living with chronic pain seek non-medication approaches to help manage their symptoms. Weighted blankets are commonly used to promote relaxation and comfort during sleep, but there is limited research examining their potential role in supporting people with chronic pain. This pilot study will explore the experiences of adults with chronic pain who use a weighted blanket during sleep. The study aims to better understand whether nightly use of a weighted blanket may be associated with changes in pain, sleep, and daily functioning. Findings from this study will help inform future research on non-medication approaches to managing chronic pain. Approximately 44 adults with chronic pain will participate in the study. Participation will last about five weeks. After completing a virtual enrollment visit and baseline questionnaires, participants will receive a weighted blanket sized to approximately 10 percent of their body weight. Participants will first complete a 7-day adjustment period using the blanket while sleeping. If they tolerate the blanket and use it nightly during this period, they will continue into a 4-week study phase in which they will use the weighted blanket each night. During the study, participants will complete brief online surveys about their experiences and adherence to using the blanket. Pain and quality-of-life questionnaires will be completed at multiple time points, including at the start and end of the study. Participants will also provide feedback about their experience using the weighted blanket. Results from this pilot study will help researchers better understand how weighted blankets may be used by adults with chronic pain and may help guide the design of future studies evaluating non-pharmacologic approaches to pain management.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age: Male and non-pregnant female adult participants must 18 years of age or older

• Duration of pain: at least 3 months

• Average Pain Intensity over the past week: ≥3/10 NRS

• Safely able to lift a weighted blanket that is 10% of the participant's self-reported body weight (10-25 lbs.) without assistance.

• Willing to sleep with a weighted blanket (10-25 lbs.) for a total of 35 (7 days for Run-In/Adjustment + 28 days of trial).

• Willing to maintain current dietary patterns, activity level, and stable body weight for the duration of the study.

• Willing to undergo study procedures, including completion of online questionnaires and surveys, and attend virtual study visits.

• Informed Consent: Participants must be able to provide informed consent and comply with the study procedure.

• Able to speak, read, and understand English.

• Able to access WIFI to attend virtual visits and complete study surveys.

Locations
United States
Oregon
National University of Natural Medicine
RECRUITING
Portland
Contact Information
Primary
Carina Staab, DC, MEd
cstaab@nunm.edu
503-552-1862
Backup
Tara Hansen, BA, BS
EMBRACEStudy@nunm.edu
Time Frame
Start Date: 2026-05-27
Estimated Completion Date: 2026-09-15
Participants
Target number of participants: 44
Treatments
Experimental: Weighted Blanket Nightly Use for Chronic Pain
Participants will receive a weighted blanket sized to approximately 10 percent of their body weight and will be instructed to use the blanket nightly during sleep. The study includes a 7-day run-in adjustment period followed by a 4-week intervention period. The run-in period allows participants to become accustomed to the blanket and assess tolerability. Participants who tolerate the blanket will continue using it nightly for the 4-week study phase. Participants will complete questionnaires at baseline, after the run-in period, and at the end of the study, along with brief weekly surveys to report adherence and experiences using the weighted blanket.
Related Therapeutic Areas
Sponsors
Leads: National University of Natural Medicine

This content was sourced from clinicaltrials.gov