Abstract
PURPOSE: Two previous independent double-blind randomized studies demonstrated that thermal neuromodulation using high temperature pulsed heat reduced pain in subjects with chronic low back pain. The present study examined the effects of high temperature pulsed heat via an experimental device in a real-world In-Home Use Trial (IHUT) over a sixty-day period. MATERIALS AND METHODS: This in-home study recruited 34 subjects with chronic low back pain, provided them with an experimental device that delivered treatment session of high temperature pulsed heat up to 45°C, and followed them for eight weeks. Subjects were allowed to use the device as needed. Primary outcome was pain rating as measured by the 11-point Numeric Pain Scale at baseline, four and eight weeks of treatment. The secondary outcome measures were the interference with daily living components of the Brief Pain Inventory at baseline versus eight weeks of treatment. RESULTS: Thirty-two subjects completed the study. Pain levels were 5.81 at baseline, 2.79 at four weeks and 2.25 at eight weeks. All changes in pain levels between baseline and four weeks, baseline, and eight weeks and between four and eight weeks were statistically significant (p < 0.05). At eight weeks, the seven components of pain interference with activities of daily living and pain interference with walking were statistically reduced (P < 0.05). About 72% of subjects reported a single 30-minute treatment session produced over 3 hours of pain relief. CONCLUSION: An eight-week in-home trial of high-temperature thermal modulation devices produced significant reductions in pain and pain interference with activities of daily living, an important measure of function. Efforts were made to control and reduce study contamination. This study provides important initial data for long-term outcome studies of thermal neuromodulation using high temperature pulsed heat to treat low back pain and to improve subject function and demonstrated that individuals with chronic pain can effectively self-manage pain.