Effect of comorbid migraine on propranolol efficacy for painful TMD in a randomized controlled trial.

INTRODUCTION: The migraine-preventive drug propranolol is efficacious in reducing pain from temporomandibular disorder, suggesting potential modifying or mediating effects of comorbid migraine. METHODS: In this randomized controlled trial, myofascial temporomandibular disorder patients were treated with propranolol or placebo for 9 weeks. The primary endpoint was change in a facial pain index derived from daily symptom diaries. Linear and logistic regression models tested for a migraine × treatment-group interaction in reducing facial pain index. Counterfactual models explored changes in headache impact and heart rate as mediators of propranolol's efficacy. RESULTS: Propranolol's efficacy in reducing facial pain index was greater among the 104 migraineurs than the 95 non-migraineurs: For example, for the binary ≥ 30% reduction in facial pain index, odds ratios were 3.3 (95% confidence limits: 1.4, 8.1) versus 1.3 (0.5, 3.2), respectively, although the interaction was statistically non-significant (p = 0.139). Cumulative response curves confirmed greater efficacy for migraineurs than non-migraineurs (differences in area under the curve 26% and 6%, respectively; p = 0.081). While 9% of the treatment effect was mediated by reduced headache impact, 46% was mediated by reduced heart rate. CONCLUSIONS: Propranolol was more efficacious in reducing temporomandibular disorder pain among migraineurs than non-migraineurs, with more of the effect mediated by reduced heart rate than by reduced headache impact. STUDY IDENTIFICATION AND REGISTRATION: SOPPRANO; NCT02437383; https://clinicaltrials.gov/ct2/show/NCT02437383.

Efficacy and safety of propranolol for treatment of temporomandibular disorder pain: a randomized, placebo-controlled clinical trial.

Propranolol is a nonselective beta-adrenergic receptor antagonist. A multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 2b trial enrolled participants aged 18 to 65 years with temporomandibular disorder myalgia to evaluate efficacy and safety of propranolol compared with placebo in reducing facial pain. Participants were randomized 1:1 to either extended-release propranolol hydrochloride (60 mg, BID) or placebo. The primary endpoint was change in facial pain index (FPI = facial pain intensity multiplied by facial pain duration, divided by 100). Efficacy was analyzed as a mean change in FPI from randomization to week 9 and as the proportion of participants with ≥30% or ≥50% reductions in FPI at week 9. Regression models tested for treatment-group differences adjusting for study site, sex, race, and FPI at randomization. Of 299 participants screened, 200 were randomized; 199 had at least one postrandomization FPI measurement and were included in intention-to-treat analysis. At week 9, model-adjusted reductions in mean FPI did not differ significantly between treatment groups (-1.8, 95% CL: -6.2, 2.6; P = 0.41). However, the proportion with a ≥30% reduction in FPI was significantly greater for propranolol (69.0%) than placebo (52.6%), and the associated number-needed-to-treat was 6.1 (P = 0.03). Propranolol was likewise efficacious for a ≥50% reduction in FPI (number-needed-to-treat = 6.1, P = 0.03). Adverse event rates were similar between treatment groups, except for more frequent fatigue, dizziness, and sleep disorder in the propranolol group. Propranolol was not different from placebo in reducing mean FPI but was efficacious in achieving ≥30% and ≥50% FPI reductions after 9 weeks of treatment among temporomandibular disorder participants.

A Comparison of Technique Errors using Two Radiographic Intra-oral Receptor-holding Devices.

PURPOSE: Technological advances in intra-oral receptors have resulted in film-holding devices that may or may not be interchangeable with photostimulable phosphor receptors. This study evaluated the number and types of technique errors that occurred when using PSP receptors with a standard film-holding device and a dual PSP/film-designed device. METHODS: The Rinn XCP-ORA® (Standard) and the Rinn Flip-Ray® PA device (Test) were compared using rectangular collimation. DenOptix® imaging plates (sizes 1 and 2) were used as receptors. Fourteen periapical (10-size 2 and 4-size 1) projections were exposed per full mouth series on each Dental X-ray Teaching and Training Replica with both devices. Five Dental X-ray Teaching and Training Replicas were exposed by 3 experienced radiographers. Data were analyzed using a paired t-test to determine differences in the performance scores between the 2 devices. Technique errors (receptor placement, vertical angulation, horizontal angulation and cone centering) were reported using frequencies. An experienced evaluator critiqued each projection. RESULTS: A total of 15 full mouth series (210 projections) were taken per device. The mean performance scores per device were 88.4 (standard device) and 88.1 (test device) and were not statistically different (p=0.88). Cone centering errors were the most common error observed in both the standard (36%) and test (43%) devices. Receptor placement errors occurred when using the standard (12%) and test (9%) devices. Vertical and horizontal errors were <2% for both devices. CONCLUSION: Devices designed for use with film may be used interchangeably with photostimulable phosphor receptors. Some difference was noticed between devices regarding error type and occurrence.