The Effect of Topical Theraflex^® in the Treatment of Masseter Muscle and the Temporomandibular Joint Pain

Objective: This double blind study was designed to evaluate the effectiveness of the topical cream, Theraflex in patients with masseter muscle and TMJ pain. Methods: One hundred two subjects were solicited in order of appearance,from patients seeking treatment at a TMJ Center. Five males and 47 females volunteered. They all presented with a diagnosis of temporomandibular joint pain and masseter pain according to Research Diagnostic Criteria for Temporomandibular Disorders. Patients were assigned randomly to two equal groups: (1) experimental, using Theraflex cream (NaBob/Rx San Mateo California) and (2) control, using a placebo cream. After a preliminary pain rating, patients applied ¼ teaspoon of the cream to the afflicted masseter muscle(s) or over the jaw joint(s). After 7 minutes they rated their pain levels. This procedure was repeated twice daily over a period of two weeks. Masseter muscle pain and TMJ pain were measured with a 10-point Numerical Graphic Rating Scale. Results: A Two-way (Mixed AB) Factorial Analysis of Variance was conducted to evaluate pain level over the four time periods for both groups. At baseline, the mean for the Theraflex (5.09) and the placebo (4.25) showed no significance (p>0.10). The analysis indicated a significant main effect in reduction of pain during the time periods (F df=3=7.43, p=0.0002). There was a decrease in pain in the Theraflex group (mean=5.09 to 3.7, p>0.02) while there was no significant effect (F df=1 =3.38, p=0.10) for the placebo group (mean=4.25 to 3.11, p<0.10). There was evidence of minor side effects such as skin irritation (rash) and/or burning on the site of the application in four subjects (2 in experimental group and 2 in the placebo). Conclusion: The data suggest strongly that Theraflex topical cream is safe and effective for reducing pain in the masseter muscle and temporomandibular joint.