Weighted Blanket for Chronic Pain

(WB Trial)

Recruiting at 1 trial location

Overseen By Irina Strigo, 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

Trial Summary

What is the purpose of this trial?

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. Sensory interventions may offer effective, low-cost complementary tools for chronic pain and sleep disturbance in Veterans. Weighted Blankets (WB)- blankets sewn with weighted material inside to provide widespread pressure to the body- are a low-cost wellness product used for anxiety and sleep. WBs have demonstrated large reductions in insomnia, and the investigators have also shown that they can reduce the severity of chronic pain. However, effects and mechanisms of longer WB use have not been examined in individuals with pain and sleep disturbance. The investigators therefore propose a randomized controlled trial examining the effects of WBs on pain and sleep quality in Veterans. the investigators will recruit Veterans with chronic pain and sleep disturbance from the VA San Diego Healthcare System (VASDHS) and VA San Francisco Healthcare System (VASFHS) and randomize 160 Veterans to receive either a light (3-lb; N = 80) or heavy (15-lb; N = 80) blanket. The investigators will remotely collect measures of pain (primary), pain catastrophizing, and pain medication use, as well as sleep disturbance (primary) and sleep efficiency and total sleep time over 6 weeks of overnight home use of the assigned blanket. The investigators will also explore physiological effects of WBs on sleep quality using actigraphy (exploratory) in VASDHS participants. Ecological momentary assessment (EMA) methods will be deployed via smartphone to capture study adherence.

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 data supports the effectiveness of the treatment Weighted Blanket for chronic pain?

Research shows that using a heavy weighted blanket can reduce the severity of chronic pain, especially in people with high anxiety. This effect is thought to be due to the calming pressure the blanket provides, which can help improve mood and reduce pain perception. ^{1 2 3 4 5}

Is using a weighted blanket generally safe for humans?

There is no specific safety data available for weighted blankets in the provided research articles. ^{6 7 8 9 10}

How is the weighted blanket treatment different from other treatments for chronic pain?

The weighted blanket treatment is unique because it uses deep pressure stimulation, which can provide a calming effect and improve sleep, unlike traditional treatments that often focus on medication or physical activity. This approach is non-invasive and can be used at home, offering a comforting alternative for managing chronic pain. ^{11 12 13 14 15}

Research Team

Laura K Case, PhD

Principal Investigator

VA San Diego Healthcare System, San Diego, CA

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Widespread Pressure Delivered by a Weighted Blanket Reduces Chronic Pain: A Randomized Controlled Trial. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Weighted Blankets for Pain and Anxiety Relief in Acutely Injured Trauma Patients. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of the Weighted Blanket With Psychiatric Patients in the Emergency Department: A Pilot Study. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Using weighted blankets in an inpatient mental health hospital to decrease anxiety. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Weighted Blankets and Sleep Quality in Children with Autism Spectrum Disorders: A Single-Subject Design. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Guidelines for case reports of adverse events related to acupuncture. [2019]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Injury and death associated with incidents reported to the patient safety net. [2009]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Pharmacovigilance of herbal medicines: the potential contributions of ethnobotanical and ethnopharmacological studies. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Adverse events of massage therapy in pain-related conditions: a systematic review. [2022]

10. Scotland pubmed.ncbi.nlm.nih.gov

Defining adverse events in manual therapy: an exploratory qualitative analysis of the patient perspective. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Physical activity and exercise for chronic pain in adults: an overview of Cochrane Reviews. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Physical activity and exercise for chronic pain in adults: an overview of Cochrane Reviews. [2023]

13. England pubmed.ncbi.nlm.nih.gov

Fibromyalgia pain management effectiveness from the patient perspective: a qualitative evidence synthesis. [2023]

14. England pubmed.ncbi.nlm.nih.gov

Acceptability and Effects of Commercially Available Activity Trackers for Chronic Pain Management Among Older African American Adults. [2022]

15. Netherlands pubmed.ncbi.nlm.nih.gov

Physical exercise as non-pharmacological treatment of chronic pain: Why and when. [2022]