Weighted Blanket for Chronic Pain
(WB Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
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
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.
12345Is using a weighted blanket generally safe for humans?
There is no specific safety data available for weighted blankets in the provided research articles.
678910How 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.
1112131415Eligibility 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
I am 18 years old or older.
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.
+1 more
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.
+3 more
Trial 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
Participant Groups
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.
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 Clinic Near You
Research Locations NearbySelect from list below to view details:
VA San Diego Healthcare System, San Diego, CASan Diego, CA
San Francisco VA Medical Center, San Francisco, CASan Francisco, CA
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Who Is Running the Clinical Trial?
VA Office of Research and DevelopmentLead Sponsor
References
Widespread Pressure Delivered by a Weighted Blanket Reduces Chronic Pain: A Randomized Controlled Trial. [2022]Pleasant sensation is an underexplored avenue for modulation of chronic pain. Deeper pressure is perceived as pleasant and calming, and can improve sleep. Although pressure can reduce acute pain, its effect on chronic pain is poorly characterized. The current remote, double-blind, randomized controlled trial tested the hypothesis that wearing a heavy weighted blanket - providing widespread pressure to the body - relative to a light weighted blanket would reduce ratings of chronic pain, mediated by improvements in anxiety and sleep. Ninety-four adults with chronic pain were randomized to wear a 15-lb. (heavy) or 5-lb. (light) weighted blanket during a brief trial and overnight for one week. Measures of anxiety and chronic pain were collected pre- and post-intervention, and ratings of pain intensity, anxiety, and sleep were collected daily. After controlling for expectations and trait anxiety, the heavy weighted blanket produced significantly greater reductions in broad perceptions of chronic pain than the light weighted blanket (Cohen's f = .19, CI [-1.97, -.91]). This effect was stronger in individuals with high trait anxiety (P = .02). However, weighted blankets did not alter pain intensity ratings. Pain reductions were not mediated by anxiety or sleep. Given that the heavy weighted blanket was associated with greater modulation of affective versus sensory aspects of chronic pain, we propose that the observed reductions are due to interoceptive and social/affective effects of deeper pressure. Overall, we demonstrate that widespread pressure from a weighted blanket can reduce the severity of chronic pain, offering an accessible, home-based tool for chronic pain. The study purpose, targeted condition, study design, and primary and secondary outcomes were pre-registered in ClinicalTrials.gov (NCT04447885: "Weighted Blankets and Chronic Pain"). PERSPECTIVE: This randomized-controlled trial showed that a 15-lb weighted blanket produced significantly greater reductions in broad perceptions of chronic pain relative to a 5-lb weighted blanket, particularly in highly anxious individuals. These findings are relevant to patients and providers seeking home-based, nondrug therapies for chronic pain relief.
Weighted Blankets for Pain and Anxiety Relief in Acutely Injured Trauma Patients. [2023]To determine the impact of a weighted blanket on acute pain and anxiety in trauma patients, a preliminary prospective/retrospective study at a level-one trauma center (n = 24 patients) was conducted. In this study, 12 patients using weighted blankets for five consecutive days were compared to a matched retrospective cohort of 12 patients not using a blanket. The change in morphine milligram equivalents (MME) and alprazolam milligram equivalents (AME) over five days were compared. There was a significant difference of MME per day between the intervention group (mean MME change = -22.9) and matched controls (mean MME change = 6.2; p = 0.0072) by blanket use. Total MMEs in the intervention group decreased by 275.5 and in the control group increased by 75 between day 1 and day 5. There was no significant difference in AME change between groups (p = 0.3227). The majority of patients who took a post-intervention questionnaire reported less pain and less anxiety with blanket use compared to those without blanket use (78% and 56% of patients, respectively). To summarize, trauma patients in acute pain had less opioid use and reported less pain and anxiety when using a weighted blanket for five consecutive days compared to a control group who did not use a blanket.
Effectiveness of the Weighted Blanket With Psychiatric Patients in the Emergency Department: A Pilot Study. [2023]Restraint and seclusion continue to be used with patients demonstrating aggressive and violent behaviors while in the emergency department and as inpatients in behavioral health (BH) units. The use of sensory interventions such as the weighted blanket (WB) is garnering interest as alternatives to aid in managing anxiety, anger, and aggressive behaviors. Reports of the effectiveness of the WB have primarily been anecdotal, and results of research with children have been mixed. Only one study has been conducted with the WB with adults on an inpatient psychiatric unit.
Using weighted blankets in an inpatient mental health hospital to decrease anxiety. [2021]Patients who are involuntarily committed to a psychiatric facility often experience anxiety or increased anxiety in response to being placed in the institutional environment. The weighted blanket introduced a proactive treatment option. The purpose of this study was to evaluate patients' anxiety symptoms before and after weighted blanket, compared to a group that did not use a weighted blanket to control anxiety.
Weighted Blankets and Sleep Quality in Children with Autism Spectrum Disorders: A Single-Subject Design. [2021]The purpose of the study was to explore the efficacy of weighted blanket applications and sleep quality in children with autism spectrum disorder and behavioral manifestations of sensory processing deficits. Two 4-year-old participants diagnosed with autism spectrum disorder who also experienced sleep disturbances took part in a single-subject design study. Objective sleep measures and caregiver surveys were tracked for a baseline period of eight days, followed by a 14-day weighted blanket intervention and a seven-day withdrawal phase. Caregiver reports and objective data were evaluated using visual analysis and the percentage of non-overlapping data methods. The results suggest minimal changes in sleep patterns as a result of the weighted blanket intervention. The findings based on using a weighted blanket intervention were enhanced morning mood after night use and a significantly decreased time to fall asleep for participants, though they were not strong enough to recommend for clinical use. Future directions include single-subject and cohort-designed studies exploring the efficacy of weighted blankets with increasing sleep quality among children with autism.
Guidelines for case reports of adverse events related to acupuncture. [2019]Numerous case reports of adverse events of acupuncture have been published, mostly in journals which are not related to acupuncture. The authors usually have no training in acupuncture. In principle, case reports on adverse events are of value as an aid for learning. They can only achieve this effect if useful information is provided. In the case of acupuncture related adverse events and complications, basic information about the patient and the therapist as well as the treated acupuncture points and topographical regions and the needling technique are desirable. This article offers suggestions on what details should be included in a case report on adverse events related to acupuncture.
Injury and death associated with incidents reported to the patient safety net. [2009]The authors retrospectively evaluated anonymously submitted inpatient medical error reports from 8 institutions participating in the University HealthSystem Consortium Patient Safety Net (PSN) in 2004 in an attempt to focus patient safety efforts on problems that were most commonly associated with harm. Of the 25,300 incidents reported, 3381 (13.3%) were associated with adverse events (AEs), and 109 (0.4%) were associated with death. Although the most commonly reported categories of incidents associated with AEs were complications of procedure/treatment/test (29%), falls (17%), and medication errors (10%), the taxonomy of the PSN limited efforts to find specific errors in care that might be addressed by attempts to improve patient safety. Skin breakdown and falls were confirmed as presenting substantial risks to hospitalized patients, in that 59% of the incidents reported in the skin integrity category and 22% of falls resulted in AEs. The benefits and limitations of a voluntary reporting system are discussed.
Pharmacovigilance of herbal medicines: the potential contributions of ethnobotanical and ethnopharmacological studies. [2022]Typically, ethnobotanical/ethnopharmacological (EB/EP) surveys are used to describe uses, doses/dosages, sources and methods of preparation of traditional herbal medicines; their application to date in examining the adverse effects, contraindications and other safety aspects of these preparations is limited. From a pharmacovigilance perspective, numerous challenges exist in applying its existing methods to studying the safety profile of herbal medicines, particularly where used by indigenous cultures. This paper aims to contribute to the methodological aspects of EB/EP field work, and to extend the reach of pharmacovigilance, by proposing a tool comprising a list of questions that could be applied during interview and observational studies. The questions focus on the collection of information on the safety profile of traditional herbal medicines as it is embedded in traditional knowledge, as well as on identifying personal experiences (spontaneous reports) of adverse or undesirable effects associated with the use of traditional herbal medicines. Questions on the precise composition of traditional prescriptions or 'recipes', their preparation, storage, administration and dosing are also included. Strengths and limitations of the tool are discussed. From this interweaving of EB/EP and pharmacovigilance arises a concept of ethnopharmacovigilance for traditional herbal medicines: the scope of EB/EP is extended to include exploration of the potential harmful effects of medicinal plants, and the incorporation of pharmacovigilance questions into EB/EP studies provides a new opportunity for collection of 'general' traditional knowledge on the safety of traditional herbal medicines and, importantly, a conduit for collection of spontaneous reports of suspected adverse effects. Whether the proposed tool can yield data sufficiently rich and of an appropriate quality for application of EB/EP (e.g. data verification and quantitative analysis tools) and pharmacovigilance techniques (e.g. causality assessment and data mining) requires field testing.
Adverse events of massage therapy in pain-related conditions: a systematic review. [2022]Pain-related massage, important in traditional Eastern medicine, is increasingly used in the Western world. So the widening acceptance demands continual safety assessment. This review is an evaluation of the frequency and severity of adverse events (AEs) reported mainly for pain-related massage between 2003 and 2013. Relevant all-languages reports in 6 databases were identified and assessed by two coauthors. During the 11-year period, 40 reports of 138 AEs were associated with massage. Author, year of publication, country of occurrence, participant related (age, sex) or number of patients affected, the details of manual therapy, and clinician type were extracted. Disc herniation, soft tissue trauma, neurologic compromise, spinal cord injury, dissection of the vertebral arteries, and others were the main complications of massage. Spinal manipulation in massage has repeatedly been associated with serious AEs especially. Clearly, massage therapies are not totally devoid of risks. But the incidence of such events is low.
Defining adverse events in manual therapy: an exploratory qualitative analysis of the patient perspective. [2022]Rare, serious, and common, benign adverse events (AE) are associated with MT techniques. A proposed standard for defining AE in manual therapy (MT) practise has been published but it did not include the patient perspective. Research comparing clinician and patient reporting of AE demonstrates that several differences exist; for example, the reporting of objective versus subjective events. The objective of this study was to describe how patients define AE associated with MT techniques. A descriptive qualitative design was employed. Semi-structured interviews were used with a purposive sample of patients (n = 13) receiving MT, from physiotherapy, chiropractic and osteopathic practises in Ontario, Canada. The interview guide was informed by existing evidence and consultation with content and methodological experts. Interviews were audiotaped and transcribed verbatim. Date were analysed by two independent team members using thematic content analysis. A key finding was that patients defined mild, moderate and major AE by pain/symptom severity, functional impact, duration and by ruling out of alternative causes. An overarching theme identified multiple factors that influence how the AE is perceived. These concepts differ from the previously proposed framework for defining AE that did not include the patient perspective. Future processes to create standard definitions or measures should include the patient viewpoint to provide a broader, client-centred foundation.
Physical activity and exercise for chronic pain in adults: an overview of Cochrane Reviews. [2023]Chronic pain is defined as pain lasting beyond normal tissue healing time, generally taken to be 12 weeks. It contributes to disability, anxiety, depression, sleep disturbances, poor quality of life, and healthcare costs. Chronic pain has a weighted mean prevalence in adults of 20%.For many years, the treatment choice for chronic pain included recommendations for rest and inactivity. However, exercise may have specific benefits in reducing the severity of chronic pain, as well as more general benefits associated with improved overall physical and mental health, and physical functioning.Physical activity and exercise programmes are increasingly being promoted and offered in various healthcare systems, and for a variety of chronic pain conditions. It is therefore important at this stage to establish the efficacy and safety of these programmes, and furthermore to address the critical factors that determine their success or failure.
Physical activity and exercise for chronic pain in adults: an overview of Cochrane Reviews. [2023]Chronic pain is defined as pain lasting beyond normal tissue healing time, generally taken to be 12 weeks. It contributes to disability, anxiety, depression, sleep disturbances, poor quality of life, and healthcare costs. Chronic pain has a weighted mean prevalence in adults of 20%.For many years, the treatment choice for chronic pain included recommendations for rest and inactivity. However, exercise may have specific benefits in reducing the severity of chronic pain, as well as more general benefits associated with improved overall physical and mental health, and physical functioning.Physical activity and exercise programmes are increasingly being promoted and offered in various healthcare systems, and for a variety of chronic pain conditions. It is therefore important at this stage to establish the efficacy and safety of these programmes, and furthermore to address the critical factors that determine their success or failure.
Fibromyalgia pain management effectiveness from the patient perspective: a qualitative evidence synthesis. [2023]This qualitative evidence synthesis aimed to identify and integrate findings where adults with fibromyalgia discussed how they managed their pain, and their perceptions of prescribed treatments from healthcare professionals.
Acceptability and Effects of Commercially Available Activity Trackers for Chronic Pain Management Among Older African American Adults. [2022]Wearable activity trackers may facilitate walking for chronic pain management.
Physical exercise as non-pharmacological treatment of chronic pain: Why and when. [2022]Chronic pain broadly encompasses both objectively defined conditions and idiopathic conditions that lack physical findings. Despite variance in origin or pathogenesis, these conditions are similarly characterized by chronic pain, poor physical function, mobility limitations, depression, anxiety, and sleep disturbance, and they are treated alone or in combination by pharmacologic and non-pharmacologic approaches, such as physical activity (aerobic conditioning, muscle strengthening, flexibility training, and movement therapies). Physical activity improves general health, disease risk, and progression of chronic illnesses such as cardiovascular disease, type 2 diabetes, and obesity. When applied to chronic pain conditions within appropriate parameters (frequency, duration, and intensity), physical activity significantly improves pain and related symptoms. For chronic pain, strict guidelines for physical activity are lacking, but frequent movement is preferable to sedentary behavior. This gives considerable freedom in prescribing physical activity treatments, which are most successful when tailored individually, progressed slowly, and account for physical limitations, psychosocial needs, and available resources.