13. CONTINUOUS LOW-LEVEL HEAT THERAPY IS MORE EFFECTIVE THAN IBUPROFEN OR ACETAMINOPHEN FOR TREATING LOW BACK PAIN. SF Nadler, D.O.1, DJ Steiner, M.D.2, M.S., GN Erasala, M.S.3, DA Hengehold, M.S.3, RT Hinkle, B.S.3, MB Goodale, B.S.3, SB Abeln, B.S.3, KW Weingand, D.V.M., Ph.D.3 Introduction: Low-back pain (LBP) is commonly self-treated with over-the-counter (OTC) ibuprofen and acetaminophen. Clinical practice guidelines in the United States have advocated the use of these nonprescription medications along with the use of self-administered topical heat therapy at home in the initial management of acute LBP. The goal of treatment is to allow for early return to normal activities. Unfortunately, thermotherapy usually requires the individual to remain immobile during use, restricting activity. A wearable source of topical heat was created to provide the benefits of thermo-therapy while allowing for the maintenance of normal daily activities. The purpose of this study was to compare the efficacy of oral OTC analgesics to continuous low-level heatwrap therapy for the treatment of acute muscular LBP. Methods and Materials: The study was a prospective, randomized, controlled, single (investigator) blind trial incorporating 2 days of treatment at 11 clinical test sites in the United States. Three hundred seventy-one subjects (18-55 years old) with acute muscular LBP were stratified by gender and baseline pain intensity, then randomly assigned to one of five groups: heated back wrap (n=113), oral ibuprofen (1200 mg/day; n=106), oral acetaminophen (4000 mg/day; n=113) for the evaluation of efficacy, or oral placebo (n=20), or an unheated back wrap (n=19) for the purposes of blinding. Of these, 354 were evaluable for the primary efficacy analysis, day 1 mean pain relief. Secondary variables included extended pain relief (days 3 & 4), trunk flexibility (days 2 & 4), muscle stiffness (day 1), and Roland Morris disability (days 2 & 4). Results: Day 1 pain relief for the heatwrap group (mean 2.00) was significantly higher than for ibuprofen (1.51, p=0.0007) and acetaminophen (1.32, p=0.0001). After the treatment was stopped, extended pain relief (day 3-4) for the heatwrap (mean 2.61) was significantly higher than for ibuprofen (1.68, p=0.0001) and acetaminophen (1.95, p=0.0009). Lateral trunk flexibility was significantly improved for the heatwrap on day 2 (p=0.009 versus acetaminophen, p=0.001 versus ibuprofen) and on day 4 (p=0.05 versus acetaminophen, p=0.007 versus ibuprofen). Muscle stiffness reduction on day 1 for the heatwrap (mean=16.3) was significantly greater than for acetaminophen (mean=10.5, p=0.001). Disability was reduced with heatwrap therapy as compared to ibuprofen (p=0.009) on day 2, and compared to both ibuprofen (p=0.0001) and acetaminophen (p=0.0007) on day 4. Discussion: Continuous low level heatwrap therapy was shown to provide superior therapeutic benefits in the treatment of acute LBP when compared to the maximum recommended nonprescription dosages of the most commonly utilized oral analgesics. These findings may be the result of increased muscle relaxation, connective tissue elasticity, blood flow, and tissue healing potential provided through the combination of physical support and continuous low-level topical heat. Heatwrap therapy is a new therapeutic strategy that allows painful subjects to maintain normal activities during treatment and may offer superior therapeutic benefits over oral analgesics.

24. CONTINUOUS LOW-LEVEL TOPICAL HEAT THERAPY IS EFFECTIVE FOR TREATING LOW BACK PAIN. KW Weingand, GN Erasala, DA Hengehold, MB Goodale, DJ Steinerf, SF Nadler*; The Procter & Gamble Company, Mason, OH; fResearch Testing Laboratories, Great Neck, NY; *New Jersey Medical School, Newark, NJ. The objective of this randomized, controlled, single-blind, parallel study was to determine the efficacy of continuous low-level heat therapy in subjects with acute muscular low back pain. Subjects with moderate or greater pain intensity were enrolled. Subjects were stratified by gender and baseline pain intensity, then randomly assigned to one of four treatments: H= heated back wrap (n=95), PBO= oral placebo (n=96), IBU= oral ibuprofen (n=12) or U= unheated back wrap (n=16). Back wraps were worn for 8 hours daily on 3 consecutive days. IBU was dosed 400 mg t.i.d. (1200 mg/day). Treatment response was assessed by measuring pain relief, muscle stiffness, trunk range of motion and Roland Morris disability. Primary and secondary analyses determined that, H when compared to PBO, provided significant increases in day 1 mean pain relief (1.76 vs. 1.05; p = 0.0001) and trunk range of motion (17.3 vs. 15.9 cm; p = 0.004) and decreases in muscle stiffness (43.1 vs. 47.6; p = 0.008) and disability (22% vs. 31%, day3 ; p = 0.0002). Additional analyses showed that, H was superior to U (2.13 vs. 1.46; p = 0.018) and IBU (2.13 vs. 1.30; p = 0.008) in providing greater pain relief during the 3 day treatment period. The therapeutic benefits were evident during both the 3 day treatment period as well as during the 2 day follow-up period. Continuous low-level heat therapy was shown to be clinically effective for treating acute muscular low back pain as evidenced by significant improvements in all efficacy variables.

26. CONTINUOUS LOW-LEVEL TOPICAL HEAT THERAPY IS EFFECTIVE FOR TREATING LOW BACK PAIN. KW Weingand, GN Erasala, DA Hengehold, MB Goodale, DJ Steinerf, SF Nadler*; The Procter & Gamble Company, Mason, OH, USA; fResearch Testing Laboratories, Great Neck, NY, USA; *New Jersey Medical School, Newark, NJ, USA. Aims: The objective of this randomized, controlled, single-blind, parallel study was to determine the efficacy of continuous low-level heatwrap therapy in subjects with acute muscular low back pain. Methods: Subjects with moderate or greater pain intensity were enrolled. Subjects were stratified by gender and baseline pain intensity, then randomly assigned to one of four treatments: H= heated back wrap (n=95), PBO= oral placebo (n=96), IBU= oral ibuprofen (n=12) or U= unheated back wrap (n=16). Back wraps were worn for 8 hours daily on 3 consecutive days. IBU was dosed 400 mg t.i.d. (1200 mg/day). Treatment response was assessed by measuring pain relief, muscle stiffness, trunk range of motion and Roland Morris disability. Results: Primary and secondary analyses determined that, H when compared to PBO, provided significant increases in day 1 mean pain relief (1.76 vs. 1.05; p = 0.0001) [Figure 1] and trunk range of motion (17.3 vs. 15.9 cm; p = 0.004) and decreases in muscle stiffness (43.1 vs. 47.6; p = 0.008) and disability (22% vs. 31%, day3 ; p = 0.0002). Additional analyses showed that, H was superior to U (2.13 vs. 1.46; p = 0.018) and IBU (2.13 vs. 1.30; p = 0.008) in providing greater pain relief during the 3 day treatment period. The therapeutic benefits were evident during both the 3 day treatment period as well as during the 2 day follow-up period. Conclusions: Continuous low-level heatwrap therapy was shown to be clinically effective for treating acute muscular low back pain as evidenced by significant improvements in all efficacy variables.

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