Ignite Creation Date:
2024-05-06 @ 7:19 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05963607
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2023-07-18
Brief Title:
RCT of a Weighted Blanket to Reduce Pain in Veterans With Chronic Pain
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
RCT of a Weighted Blanket to Reduce Pain in Veterans With Chronic Pain
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WB
Brief Summary:
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
Detailed Description:
Chronic pain is a major health concern for returning Veterans15 and is associated with decreases in quality of life16 increased opioid usemisuse and self-injury1718 and significant emotional toll on the patient and medical provider19 The management of pain is a high priority for the Veterans Administration VA20 and VA primary care providers21 In addition chronic pain is highly comorbid with significant disturbance in sleep22 and sleep fragmentation and poor sleep in turn are associated with increases in pain sensitivity and pain interference2324 Decreasing sleep disturbance among Veterans with chronic pain therefore has the potential to greatly reduce pain22 ultimately improving quality of life
Sensory interventions may offer effective low-cost complementary tools for chronic pain and sleep disturbance in Veterans Deep pressure is pleasant and calming25 and reduces acute pain8 and anxiety25 in healthy adults 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 in individuals with Cohens d 1911 and without12 psychiatric disorders as well as significant reductions in anxiety and sympathetic arousal26 Tm nlphe investigators have demonstrated that 1-week of overnight WB use can also reduce chronic pain severityinterference27 However effects and mechanisms of longer WB use have not been examined in individuals with pain and sleep disturbance The investigators posit that pressure from a WB reduces pain and anxiety while falling asleep and sleeping decreasing sleep fragmentation and sleep disturbance overnight and in turn decreasing pain and pain catastrophizing The investigators therefore propose a randomized controlled trial examining the effects of WBs on pain and sleep quality in Veterans
The two objectives of this CSRD Merit Review are to determine whether in Veterans with musculoskeletal chronic pain and sleep disturbance a heavy WB versus light control blanket will reduce pain impact severityinterference and sleep disturbance and whether improvements in sleep mediate such reductions in pain 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 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 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 Our central hypothesis is that although both study arms will be associated with positive clinical outcomes deeper pressure from the WB will be associated with significantly greater reductions in pain impact and sleep disturbance with improvements in sleep mediating reductions in pain The investigators will examine the following aims
Aim1 Compare the efficacy of a WB versus control blanket on pain in Veterans with musculoskeletal chronic pain and sleep disturbance Hypothesis 1a Pain impact severity and interference measured by the Pain Enjoyment of Life and General Activity PEG Scale28 primary outcome and pain catastrophizing Pain Catastrophizing Scale PCS29 will show significantly greater improvement in a group of Veterans with chronic pain over 6 weeks from nightly use of a 15-lb versus 3-lb blanket Hypothesis 1b Veterans with chronic pain using the 15-lb versus 3-lb blanket will show significantly greater reductions in pain medication use Exploratory Hypothesis 1c Pain impact of 15 vs 3-lb blanket will remain higher 12-weeks after randomization
Aim2 Compare the efficacy of a WB versus control blanket on sleep disturbance in Veterans with musculoskeletal chronic pain and sleep disturbance Hypothesis 2a Veterans using the 15-lb versus 3-lb blanket will show significantly greater improvement in sleep disturbance Insomnia Severity Index ISI30 primary outcome measure and sleep efficiency and total sleep time Daily Sleep Diary3132 over 6 weeks of use of a 15-lb versus 3-lb blanket Exploratory Hypothesis 2b Veterans using the 15-lb versus 3-lb blanket will show increased sleep efficiency and total sleep time measured by actigraphy after six weeks of use
Aim3 Examine the mediation effect of sleep on pain Hypothesis 3a Decreases in sleep disturbance Insomnia Severity Index ISI30 will mediate reductions in pain impact PEG28 over the 6-week intervention Exploratory Hypothesis 3b Improvements in sleep efficiency actigraphy will mediate reductions in PEG pain
Our expected outcomes are to identify the effects of a WB on chronic pain and sleep disturbance and the relationship between these clinical factors The proposed research findings will have a positive impact by providing evidence for effects on chronic pain and sleep disturbance for this novel accessible and fully remote intervention Study results will inform both future research and treatment of chronic pain
Sensory interventions may offer effective low-cost complementary tools for chronic pain and sleep disturbance in Veterans Deep pressure is pleasant and calming25 and reduces acute pain8 and anxiety25 in healthy adults 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 in individuals with Cohens d 1911 and without12 psychiatric disorders as well as significant reductions in anxiety and sympathetic arousal26 Tm nlphe investigators have demonstrated that 1-week of overnight WB use can also reduce chronic pain severityinterference27 However effects and mechanisms of longer WB use have not been examined in individuals with pain and sleep disturbance The investigators posit that pressure from a WB reduces pain and anxiety while falling asleep and sleeping decreasing sleep fragmentation and sleep disturbance overnight and in turn decreasing pain and pain catastrophizing The investigators therefore propose a randomized controlled trial examining the effects of WBs on pain and sleep quality in Veterans
The two objectives of this CSRD Merit Review are to determine whether in Veterans with musculoskeletal chronic pain and sleep disturbance a heavy WB versus light control blanket will reduce pain impact severityinterference and sleep disturbance and whether improvements in sleep mediate such reductions in pain 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 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 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 Our central hypothesis is that although both study arms will be associated with positive clinical outcomes deeper pressure from the WB will be associated with significantly greater reductions in pain impact and sleep disturbance with improvements in sleep mediating reductions in pain The investigators will examine the following aims
Aim1 Compare the efficacy of a WB versus control blanket on pain in Veterans with musculoskeletal chronic pain and sleep disturbance Hypothesis 1a Pain impact severity and interference measured by the Pain Enjoyment of Life and General Activity PEG Scale28 primary outcome and pain catastrophizing Pain Catastrophizing Scale PCS29 will show significantly greater improvement in a group of Veterans with chronic pain over 6 weeks from nightly use of a 15-lb versus 3-lb blanket Hypothesis 1b Veterans with chronic pain using the 15-lb versus 3-lb blanket will show significantly greater reductions in pain medication use Exploratory Hypothesis 1c Pain impact of 15 vs 3-lb blanket will remain higher 12-weeks after randomization
Aim2 Compare the efficacy of a WB versus control blanket on sleep disturbance in Veterans with musculoskeletal chronic pain and sleep disturbance Hypothesis 2a Veterans using the 15-lb versus 3-lb blanket will show significantly greater improvement in sleep disturbance Insomnia Severity Index ISI30 primary outcome measure and sleep efficiency and total sleep time Daily Sleep Diary3132 over 6 weeks of use of a 15-lb versus 3-lb blanket Exploratory Hypothesis 2b Veterans using the 15-lb versus 3-lb blanket will show increased sleep efficiency and total sleep time measured by actigraphy after six weeks of use
Aim3 Examine the mediation effect of sleep on pain Hypothesis 3a Decreases in sleep disturbance Insomnia Severity Index ISI30 will mediate reductions in pain impact PEG28 over the 6-week intervention Exploratory Hypothesis 3b Improvements in sleep efficiency actigraphy will mediate reductions in PEG pain
Our expected outcomes are to identify the effects of a WB on chronic pain and sleep disturbance and the relationship between these clinical factors The proposed research findings will have a positive impact by providing evidence for effects on chronic pain and sleep disturbance for this novel accessible and fully remote intervention Study results will inform both future research and treatment of chronic pain
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| I01CX002591 | NIH | None | httpsreporternihgovquickSearchI01CX002591 |