Weighted Blanket for Chronic Pain

(WB Trial)

Recruiting at 1 trial location

Overseen By Matthew R Herbert, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must not be taking: Opioids

Disqualifiers: Serious mental illness, Homelessness, Opioid use disorder, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how weighted blankets can assist Veterans with chronic pain and sleep problems. Researchers aim to determine if using a light or heavy blanket at night can enhance pain levels and sleep quality. Veterans with non-cancer musculoskeletal pain and sleep issues for at least six months may qualify. Participants will use the blankets at home for six weeks, and the study will monitor changes in their pain and sleep. As an unphased trial, this study provides Veterans with a unique opportunity to explore a non-drug approach to improving their well-being.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if there have been changes to your mental health or pain treatment, including medications, in the 3 months before the trial or if changes are expected during the 2-month trial.

What prior data suggests that weighted blankets are safe for Veterans with chronic pain and sleep disturbance?

Research has shown that weighted blankets might safely help manage chronic pain. In some studies, people using a 15-pound weighted blanket reported feeling less pain, suggesting that the blankets might make pain easier to handle.

Regarding safety, weighted blankets are generally well-tolerated. One study found that they can also alleviate anxiety and improve sleep without causing harm. Thus, these blankets could be a low-risk option for those seeking better sleep and pain reduction. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for chronic pain that often rely on medications like opioids or NSAIDs, the weighted blanket provides a non-pharmacological approach. Researchers are excited about this method because it uses deep pressure stimulation, which can help reduce anxiety and improve sleep quality—both important factors in managing chronic pain. Additionally, this approach avoids potential side effects associated with long-term medication use, offering a safer alternative for individuals seeking relief.

What evidence suggests that weighted blankets are effective for chronic pain and sleep disturbance?

Research has shown that weighted blankets can help reduce chronic pain. In this trial, participants will use either a heavy blanket or a light blanket overnight for six weeks. One study found that a 15-pound weighted blanket reduced chronic pain more effectively than lighter blankets. Another study showed that heavier blankets provided more pain relief than lighter ones. The pressure from a weighted blanket is believed to ease pain and improve sleep quality. These findings suggest that using a weighted blanket might effectively manage chronic pain and sleep problems. ^{1 2 3 4 6}

Who Is on the Research Team?

Irina Strigo, PhD

Principal Investigator

San Francisco VA Medical Center, San Francisco, CA

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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.

VA-enrolled

Exclusion 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use either a heavy (15-lb) or light (3-lb) weighted blanket overnight for 6 weeks to assess effects on pain and sleep quality.

6 weeks

Remote monitoring with smartphone-based ecological momentary assessment

Follow-up

Participants are monitored for sustained effects on pain and sleep quality after the treatment phase.

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Weighted Blanket

Trial Overview 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.

How Is the Trial Designed?

Group I: Heavy blanket Experimental Treatment 1 Intervention

Wear heavy blanket overnight for 6 weeks

Group II: Light blanket Active Control 1 Intervention

Wear light blanket overnight for 6 weeks

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

A systematic review of 21 studies involving 37,143 participants found that physical activity and exercise can lead to small-to-moderate improvements in pain severity and physical function for adults with chronic pain, although results were inconsistent across different interventions.

The evidence quality was low due to small sample sizes and short follow-up periods, but the interventions were generally safe, with few adverse events reported, primarily mild soreness or muscle pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity and exercise for chronic pain in adults: an overview of Cochrane Reviews. Geneen, LJ., Moore, RA., Clarke, C., et al.[2023]

In a study involving 94 adults with chronic pain, using a 15-lb weighted blanket significantly reduced perceptions of chronic pain compared to a 5-lb blanket, especially in individuals with high anxiety levels.

The pain reduction was not linked to changes in pain intensity ratings or improvements in anxiety and sleep, suggesting that the benefits may stem from the calming effects of deeper pressure rather than direct pain relief mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Widespread Pressure Delivered by a Weighted Blanket Reduces Chronic Pain: A Randomized Controlled Trial. Baumgartner, JN., Quintana, D., Leija, L., et al.[2022]

Case reports of adverse events related to acupuncture are often published in non-acupuncture journals by authors lacking acupuncture training, which may limit their usefulness for learning and improving practice.

To enhance the value of these case reports, it is important to include detailed information about the patient, therapist, acupuncture points treated, and the needling technique used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guidelines for case reports of adverse events related to acupuncture. Peuker, E., Filler, T.[2019]

A systematic review of 21 studies involving 37,143 participants found that physical activity and exercise can lead to small-to-moderate improvements in pain severity and physical function for adults with chronic pain, although results were inconsistent across different interventions.

The evidence suggests that exercise has few adverse effects, with most reported issues being mild soreness or muscle pain that subsided after a few weeks, indicating that exercise can be a safe option for managing chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity and exercise for chronic pain in adults: an overview of Cochrane Reviews. Geneen, LJ., Moore, RA., Clarke, C., et al.[2023]

Patients with fibromyalgia often feel frustrated with pain management due to provider stigma and mixed effectiveness of prescribed medications, leading them to feel like 'walking chemists' with little relief.

Combining cognitive-behavioral therapy with physical exercise may enhance treatment effectiveness, while natural therapies offer short-term benefits but can be costly, highlighting the need for personalized pain management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fibromyalgia pain management effectiveness from the patient perspective: a qualitative evidence synthesis. Climent-Sanz, C., Hamilton, KR., Martínez-Navarro, O., et al.[2023]

A pilot study involving 51 older adults with chronic pain found that over 90% rated the Fitbit Zip™ tracker as easy to use, although some faced technical challenges.

Despite high satisfaction and adherence rates for reporting daily steps, the use of the tracker did not lead to significant improvements in physical functioning or walking compared to the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability and Effects of Commercially Available Activity Trackers for Chronic Pain Management Among Older African American Adults. Janevic, MR., Shute, V., Murphy, SL., et al.[2022]

Physical activity is beneficial for individuals with chronic pain, improving not only pain levels but also related symptoms like mobility, depression, and anxiety, when tailored to individual needs.

While there are no strict guidelines for physical activity in chronic pain management, frequent movement is encouraged over sedentary behavior, allowing for flexible and personalized treatment plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical exercise as non-pharmacological treatment of chronic pain: Why and when. Ambrose, KR., Golightly, YM.[2022]

In a study of 24 trauma patients, those using weighted blankets for five days significantly reduced their opioid use (morphine milligram equivalents) by an average of 275.5, while the control group actually increased their use by 75.

Patients using weighted blankets reported less pain (78%) and anxiety (56%) compared to those who did not use the blankets, suggesting that weighted blankets may be an effective non-pharmacological intervention for managing acute pain and anxiety in trauma patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weighted Blankets for Pain and Anxiety Relief in Acutely Injured Trauma Patients. Warner, SM., Tannenbaum, SL., Pathan, S., et al.[2023]

The study found that using weighted blankets significantly reduced anxiety symptoms in psychiatric patients, as evidenced by lower scores on the STAI: Y-6 inventory and decreased pulse rates after a 20-minute intervention.

This approach offers a safe and effective alternative to traditional anxiety management methods, such as medications and physical restraints, highlighting its potential for improving patient-centered care in mental health settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using weighted blankets in an inpatient mental health hospital to decrease anxiety. Becklund, AL., Rapp-McCall, L., Nudo, J.[2021]

This paper proposes a new tool for ethnobotanical and ethnopharmacological studies that focuses on gathering information about the safety profile of traditional herbal medicines, including adverse effects and personal experiences from users.

The concept of 'ethnopharmacovigilance' is introduced, which combines traditional knowledge with pharmacovigilance to enhance the understanding of the safety of herbal medicines, although the effectiveness of this tool will need to be tested in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacovigilance of herbal medicines: the potential contributions of ethnobotanical and ethnopharmacological studies. Rodrigues, E., Barnes, J.[2022]

Patients define adverse events (AEs) from manual therapy (MT) based on pain severity, functional impact, duration, and the exclusion of other causes, highlighting a more nuanced understanding of AEs than previously recognized.

The study emphasizes the importance of incorporating patient perspectives in defining AEs in MT practices, suggesting that current frameworks may overlook critical aspects of patient experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining adverse events in manual therapy: an exploratory qualitative analysis of the patient perspective. Carlesso, LC., Cairney, J., Dolovich, L., et al.[2022]

In a pilot study involving 15 adult patients in an emergency department, the use of a 15-pound weighted blanket (WB) showed greater reductions in anxiety and anger compared to groups that did not use the blanket.

While all groups experienced decreased anxiety and anger, the small sample size limited the ability to draw significant conclusions about the effectiveness of the WB as a therapeutic intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of the Weighted Blanket With Psychiatric Patients in the Emergency Department: A Pilot Study. Dickson, DA., Gantt, L., Swanson, M.[2023]

In a study involving two 4-year-old children with autism spectrum disorder, the use of weighted blankets resulted in improved morning mood and a reduced time to fall asleep, although overall changes in sleep patterns were minimal.

Despite some positive effects, the results were not strong enough to recommend weighted blankets for clinical use, indicating the need for further research with larger participant groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weighted Blankets and Sleep Quality in Children with Autism Spectrum Disorders: A Single-Subject Design. Gee, BM., Lloyd, K., Sutton, J., et al.[2021]

Out of 25,300 medical error reports analyzed from 8 hospitals, 13.3% were linked to adverse events, highlighting significant safety concerns in inpatient care.

The most frequent types of incidents leading to harm included complications from procedures (29%), falls (17%), and medication errors (10%), with skin breakdown and falls posing substantial risks, as they resulted in adverse events in 59% and 22% of cases, respectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Injury and death associated with incidents reported to the patient safety net. Reid, M., Estacio, R., Albert, R.[2009]

A review of 40 reports from 2003 to 2013 identified 138 adverse events (AEs) related to pain-related massage, highlighting that while serious complications like disc herniation and spinal cord injury can occur, the overall incidence of these events is low.

The findings suggest that although massage therapies carry some risks, particularly with spinal manipulation, they are generally considered safe when performed by qualified practitioners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events of massage therapy in pain-related conditions: a systematic review. Yin, P., Gao, N., Wu, J., et al.[2022]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S1526590021003138

Widespread Pressure Delivered by a Weighted Blanket ... This randomized-controlled trial showed that a 15-lb weighted blanket produced significantly greater reductions in broad perceptions of chronic pain.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11056563/

The effect of weighted blankets on sleep and related disorders A randomized controlled trial showed that heavier-weighted blankets produced a greater alleviation in widespread chronic pain than the lighter- ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04447885

NCT04447885 | Weighted Blankets and Chronic Pain The purpose of the study is to test whether the use of weighted blankets can change the experience of chronic pain and to examine if social, psychological, or ...

4. jpain.org jpain.org/article/S1526-5900(21)00313-8/fulltext

Widespread Pressure Delivered by a Weighted Blanket ... Highlights. A 15-lb weighted blanket reduced aspects of chronic pain more than a 5-lb weighted blanket. The heavier weighted blanket was more ...

5. discoveryjournals.org discoveryjournals.org/medicalscience/current_issue/v28/n154/e155ms3477.pdf?

Weighted blanket – a successful therapeutic tool or solely ... The heavy-weighted blanket use led to significantly greater decreases in broad perceptions of chronic pain compared with the light- weighted blanket use.

6. sciencedirect.com sciencedirect.com/science/article/pii/S096522992400092X

Safety and effectiveness of weighted blankets for symptom ... Weighted blankets may be a safe and effective add-on treatment for managing common symptoms such as anxiety, insomnia, depression, and fatigue among psychiatric ...