This randomized controlled double-blind study was designed to evaluate the effectiveness of Pulsed Radio Frequency Energy Therapy (PRFE) in patients with temporomandibular joint arthralgia. Forty subjects, 9 males and 31 females, were enrolled in the study (age range 22 to 55 y) with the diagnosis of temporomandibular joint arthralgia according to Research Diagnostic Criteria for Temporomandibular Joint Disorders. Subjects were randomly assigned into two equal groups: (1) experimental group received PRFE using the Energex unit (Orthosonix, Inc. Tappan NJ) and (2) control group received PRFE placebo treatment using a sham device. During each treatment visit both groups received six applications (15 seconds each) applied to TMJ area and this procedure was repeated 6-times over a period of 2 weeks. Joint pain was measured by a 10-point Numerical Rating Scale (NRS). Mandibular range of motion was measured in mm. Both were recorded before and after each application. ANOVA for repeated measured analyzed four time periods pre-experimentally, visit number 4, first and second week follow-up. ANOVA for NRS scores showed that there was a main effect for pain over time (F_df=3 =8.8, P < 0.0001). The experimental group decreased significantly (mean pain=6.1 to 3.0) while there was no significant effect for time in control group F_df=3 =1.9. P > 0.05 (mean pain=5.3 to 4.2). The experimental group showed a significant increase in mouth opening over time F_df=3 =4.7, P=0.0005) mean=35.3 mm to 41.7 mm. There was no significant change in the control group for mouth opening, (F_df=3 =0.3, P > 0.05) mean=38.5 mm to 39.6 mm. Similarly right and left lateral movement showed a significant increase in the experimental but not the control group. There were no side effects during or 2 weeks after the study. The results suggest strongly that PRFE is effective in reducing and eliminating TMJ arthralgia and increasing mandibular range of motion. The results also indicate that the PRFE is a safe treatment. This study was supported by a grant from Orthosonix, Inc. Tappan, NJ.

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