RCT of a Weighted Blanket to Reduce Pain in Veterans with Chronic Pain

Chronic pain is a major health concern for returning Veterans and is associated with decreases in quality of life. The management of pain, including non-drug approaches, is a high priority for the Veterans Administration (VA) and VA primary care providers. The long-term goal is to determine the efficacy and mechanism of

clinically useful interventions for chronic pain. Sensory interventions such as widespread pressure may be one effective approach. In addition to published studies documenting significant effects on anxiety and sleep, our preliminary data suggest that a Weighted Blanket (WB) is a feasible, low-cost complementary intervention for

chronic pain. In direct response to the CSR&D priority research area “Pain mechanisms and treatments including alternatives to opioids,” the overall objectives in this application are to determine whether in Veterans with chronic pain and sleep disturbance, a heavy WB versus light control blanket will reduce (i)

musculoskeletal chronic pain and (ii) sleep disturbance, and (iii) whether improvements in sleep mediate reductions in pain. Our central hypothesis is that although both study arms will be associated with positive clinical outcomes, deeper pressure will be associated with greater reductions in pain impact and sleep

disturbance, with changes in sleep mediating changes in pain. The rationale for this project is that determining the impact of WBs on chronic pain and sleep disturbance is expected to offer novel insights into the efficacy and mechanism of WBs, informing both mechanistic studies and clinical treatment. Guided by published and

strong preliminary data, our central hypothesis will be tested by pursuing three specific aims: 1) Compare the efficacy of a WB and control blanket on chronic pain in Veterans with musculoskeletal chronic pain and sleep disturbance; 2) Compare the efficacy of a WB and control blanket on sleep disturbance in Veterans with

musculoskeletal chronic pain and sleep disturbance; and 3) Examine the mediation effects of sleep on chronic pain. This will be accomplished by recruiting Veterans with musculoskeletal chronic pain and sleep disturbance and randomizing 160 Veterans to receive either a heavy (15-lb) or light (3-lb; control) blanket. We will collect

measures of pain impact (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 either blanket. Ecological momentary assessment (EMA) methods will be deployed via smartphone to capture study adherence. The

research proposed here is innovative, because it: 1) leverages recent research on the affective and sensory effects of deep pressure; 2) tests novel effects of an established intervention for sleep and anxiety; and 3) utilizes a remote intervention implemented passively during sleep, reducing participant time and effort. The

research proposed in this project is significant since it will identify effects of a low-cost, accessible intervention that has a high potential to improve chronic pain and sleep disturbance in this difficult to treat population. These innovations are expected to open new horizons in both research and treatment of chronic pain.