1. OVERNIGHT TREATMENT WITH CONTINUOUS LOW LEVEL TOPICAL HEAT THERAPY PROVIDES EFFECTIVE RELIEF OF LOW BACK PAIN. Susan B. Abeln, R.Ph.; Kurt W. Weingand Ph.D, Geetha N. Erasala, M.S., David A. Hengehold, M.S., Peggy W. Barnes R.N., Deborah J. Steiner, M.D f, The Procter & Gamble Company, Mason, OH; fResearch Testing Laboratories, Great Neck, NY. Objective: To determine the clinical efficacy and safety of the overnight use of continuous low-level heat wrap therapy in subjects with acute muscular low back pain. Setting: New York Design: Randomized, controlled, single-blind, parallel, clinical study. Participants: Seventy-six adult subjects with acute muscular low back pain of moderate or greater intensity completed the study. Subjects were stratified by gender and baseline pain intensity, then randomly assigned to one of four treatments: heated back wrap (n=33), oral placebo (n=34), oral ibuprofen; 400 mg (n=4) or unheated back wrap (n=5). Back wraps were worn for 8 hours per night on 3 consecutive nights. Oral treatments were administered once a night on 3 consecutive nights. Treatment response was assessed by subjective measures of pain relief, muscle stiffness, and objective trunk range of motion, Roland Morris disability, sleep onset difficulty and sleep quality. The skin quality was assessed as a measure of safety. Results: Heat therapy compared to placebo provided significant increases in mean 3 day morning pain relief (2.75 vs. 1.45; p = 0.00005) and trunk range of motion (20 vs. 17 cm ; p = 0.001) and decreases in muscle stiffness (36.3 vs. 47.9; p = 0.0008) and disability (15% vs. 24% ; p = 0.005). These therapeutic benefits were evident both during the 3 day treatment period as well as during the 2 day follow-up period. Conclusion: Continuous low-level heat therapy overnight was shown to be clinically effective for treating acute low back pain. In addition, heat therapy improved subjective sleep quality and reduced sleep onset difficulty. The effect of heat therapy on the skin during overnight use was minimal and comparable to daytime use.

3. THE USE OF CONTINUOUS TOPICAL HEAT IN THE TREATMENT OF DYSMENORRHEA. Mark D. Akin, M.D., HealthQuest Therapy & Research Institute, Inc., Austin, TX., Kurt W. Weingand, Ph.D., D.V.M., David A. Hengehold, M.S., Mary Beth Goodale, B.S., Robert T. Hinkle, B.S., The Procter and Gamble Company, Mason, OH, Roger P. Smith, M.D., The University of Missouri-Kansas City, Truman Medical Center, Kansas City, MO Objective: To assess the efficacy of the traditional modality of topical heat for the treatment of menstrual pain as compared to oral ibuprofen and placebo treatments. Study Design: A randomized, placebo-controlled (double dummy), parallel pilot study. Materials and Methods: At the start of menstrual pain, subjects were asked to wear an abdominal wrap (heated and unheated) for approximately 12 consecutive hours per day and to take oral medication (placebo or ibuprofen 400 mg) 3 times daily, approximately 6 hours apart. This therapy continued for 2 consecutive days. Pain intensity and pain relief were recorded at 17 time points during the study period (as prompted by a timer). Results: Eighty-four women ages 21 to 50 years of age met inclusion/exclusion criteria and enrolled, were randomized to 4 treatment groups; 81 subjects began and completed the study protocol. Over the 2 days of study, significantly greater pain relief was detected in the heat/placebo tablet group (mean=3.27, p<0.001) and the no heat/ibuprofen group (mean=3.07, p=0.001) versus the no heat/placebo tablet group (mean=1.95). Although not statistically significant, greater pain relief was observed for the combination heat/ibuprofen group (mean=3.55) versus the no heat/ibuprofen group (p=0.096). The heat/placebo group had statistically higher pain relief at the start of both the second (p=0.002) and third days of treatment (p<0.001) versus no heat/placebo. Conclusions: In this study, the application of continuous topical heat therapy performed as well or better than ibuprofen for the treatment of dysmenorrhea. Additionally, evidence for a carry-over effect of heat therapy was seen that supports the theory that heat therapy acts through a different (but completely independent) mechanism (gate control) than ibuprofen therapy.

4. THE EFFECT OF TOPICAL HEAT TREATMENT ON TRAPEZIUS MUSCLE BLOOD FLOW USING POWER DOPPLER ULTRASOUND. Erasala GN*, Rubin JM, Tuthill TA, Fowlkes JB, de Dreu SE, Hengehold DA*, Weingand KW*; Department of Radiology, University of Michigan, Ann Arbor, MI, USA and *The Procter & Gamble Company, Health Care Research Center, Mason, OH, USA. PURPOSE: To evaluate the effect of topical heat treatment on trapezius muscle vascularity (blood volume) using power Doppler ultrasound. METHODS AND MATERIALS: A temperature-controlled, heating pad (Lauda Clear-view, model MD12-BDLCM, Brinkman Instruments, Inc.) was used to heat the upper back region (mid-trapezius muscles) of six healthy volunteers. The three heating pad-skin interface temperatures tested were 38oC, 40oC and 42oC. The trapezius was chosen over other large muscles because its broad flat shape makes ultrasound sampling easy. In addition, its size, location, and proximity to the overlying skin makes it ideal for assessing vascularity using ultrasound. The changes in vascularity were measured at 18 sites in the trapezius muscles (from just below the skin surface to a depth of approximately 3 cm depending on the thickness of the muscle) pre- and 30 minutes post-heat treatment at each visit using power Doppler ultrasound (GE Logiq 700 ultrasound scanner). ANALYSES: Analysis was performed using a modification of the program, Matlab (The Mathworks, Natick, MA). A log transformation was applied to normalize the data. Mean percent change from baseline scores were calculated by subject and treatment period and analyzed using an analysis of variance for a three period crossover design. One-tailed t-tests were used to test for percent increases in vascularity from baseline. The different temperature groups were also compared using t-tests. RESULTS: Vascularity of the trapezius muscles increased 27% (p= 0.250), 77% (p=0.036), and 104% (p=0.011) with heating pad-skin interface treatment temperatures of 38oC, 40oC and 42oC respectively when compared to pre-treatment baseline measurements. CONCLUSIONS: This preliminary study indicates that topical heat treatment for 30 minutes increases the amount of vascularity in the underlying trapezius muscle up to approximately three centimeters below the surface of the skin. This increased vascularity is likely the result of increased muscle tissue blood flow and may contribute to the analgesic and muscle relaxation effects of topical heat therapy.

6. CONTINUOUS, LOW-LEVEL HEAT USE IN PROFESSIONAL BASEBALL: RESULTS OF A USAGE STUDY. Miller R*, Biggerstaff K^, Lynn Gf, Abeln Sy, Goodale MBy, Williams Dy, Weingand Ky: *The Detroit Tigers, Detroit, MI; ^The Pittsburgh Pirates, Pittsburgh, PA; fThe Cincinnati Reds, Cincinnati, OH; yThe Procter & Gamble Health Sciences Institute, Cincinnati, OH. Modalities are commonly used in the treatment of athletic injuries, with little data supporting the effects on injury outcomes and performance available for consideration when selecting treatment regimens. The objective of this study was to evaluate the usage, therapeutic benefits and outcomes associated with the use of a wearable therapeutic heatwrap providing at least 8 hours of continuous, low-level topical heat in a population of professional baseball players during spring training. Information was collected from a total of 32 athletes and 6 certified athletic trainers over a six week period. The results indicated that the heatwrap provided therapeutic benefits by reducing pain affect (unpleasantness) by 25%, reducing muscle stiffness by 25% and increasing the ability to move by 25% when compared to pre-treatment levels. The level of pain relief provided by the heatwrap (mean score 2.25) was consistent with mean scores from three randomized, controlled clinical trials conducted in a non-athletic populations treated with the same type of heatwrap therapy (range 1.8-2.6). Pain relief increased with duration of use. The extent of pain relief was also associated with specific usage occasions and was greatest when used during warm-up, post-game, during sleep and while traveling. Improved outcomes were observed, including easier warm-up and improved recovery from injury, and the overall acceptance of heatwrap therapy was high among both the athletes and the trainers who participated in the study. Continuous, low-level heatwrap therapy has a unique role in baseball sports medicine, and may provide therapeutic benefits for athletes competing in other sports as well.

Some abstracts referenced above (cont)

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