IADR Abstract Archives
Randomized Clinical Trial of Duloxetine for TMJD Pain
Objectives: Temporomandibular Joint Disorder (TMJD) is a major cause of chronic craniofacial pain. Several studies have shown a link between TMJD and fibromyalgia, and the association of widespread pain and generalized alterations in pain processing suggests that these disorders may share a common pathophysiology. Duloxetine, an antidepressant that increases 5-HT and NE-mediated neurotransmission has been FDA-approved for treatment of chronic pain. The purpose of this study was to evaluate the effect of duloxetine on TMJD pain.
Methods: This study was a double blind, placebo-controlled, parallel groups prospective study to evaluate the analgesic effect of 60 mg duloxetine taken daily in comparison to matching placebo for a 6-week period using the primary outcome measure of change in spontaneous facial pain. Case classification was established using the modified RDC-TMD. Adverse effects, co-morbid conditions, and a variety of other assessments were recorded.
Results: A total of 90 subjects were evaluated. The median age for all study participants was 39 years. Pain ratings were reported as moderate in both groups at baseline; these ratings decreased to mild in the drug group but remained at moderate in the placebo group at the end of the study. Similarly, current pain, as measured by BPI, decreased over time in the drug group but not in the placebo group. These changes followed the same pattern observed with the VAS, but the difference did not achieve statistical significance (p = 0.08). Headache was the most frequently reported co-existing pain condition by all the subjects (58.9%), followed by osteoarthritis (5.7%), and fibromyalgia (1.1%). The most commonly reported adverse effects were headache, nausea, vomiting, loss of appetite, and sleep disturbance. Adverse events occurred more frequently in the drug group at the beginning of treatment.
Conclusions: In comparison to a matching placebo, daily duloxetine treatment over 6 weeks was well-tolerated and reduced spontaneous facial pain. Our findings suggest that duloxetine may offer a safe and effective therapy for patients with painful TMJD conditions.
Methods: This study was a double blind, placebo-controlled, parallel groups prospective study to evaluate the analgesic effect of 60 mg duloxetine taken daily in comparison to matching placebo for a 6-week period using the primary outcome measure of change in spontaneous facial pain. Case classification was established using the modified RDC-TMD. Adverse effects, co-morbid conditions, and a variety of other assessments were recorded.
Results: A total of 90 subjects were evaluated. The median age for all study participants was 39 years. Pain ratings were reported as moderate in both groups at baseline; these ratings decreased to mild in the drug group but remained at moderate in the placebo group at the end of the study. Similarly, current pain, as measured by BPI, decreased over time in the drug group but not in the placebo group. These changes followed the same pattern observed with the VAS, but the difference did not achieve statistical significance (p = 0.08). Headache was the most frequently reported co-existing pain condition by all the subjects (58.9%), followed by osteoarthritis (5.7%), and fibromyalgia (1.1%). The most commonly reported adverse effects were headache, nausea, vomiting, loss of appetite, and sleep disturbance. Adverse events occurred more frequently in the drug group at the beginning of treatment.
Conclusions: In comparison to a matching placebo, daily duloxetine treatment over 6 weeks was well-tolerated and reduced spontaneous facial pain. Our findings suggest that duloxetine may offer a safe and effective therapy for patients with painful TMJD conditions.