| October 7, 2005 |
| May 14, 2008 |
| October 2005 |
| December 2009 (final data collection date for primary outcome measure) |
| Characteristic Pain Intensity [ Time Frame: 12 Months ] [ Designated as safety issue: No ] |
- Based on diaries:
- Daily levels of TMD pain and severity of cyclic symptoms. Global measures of TMD pain severity and pain related interference.
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| Complete list of historical versions of study NCT00237042 on ClinicalTrials.gov Archive Site |
| Pain-Related Interference [ Time Frame: 12 Months ] [ Designated as safety issue: No ] |
| Same as current |
| |
| Managing Temporomandibular Disorder (TMD) Symptoms |
| Hormonal Cycles in Women: Effects on TMD Pain & Symptoms |
The purpose of this study is to determine, in a population seeking treatment at a University-based clinic (University of Washington, Seattle, WA), what factors contribute to the cyclicity of TMD pain and symptoms in women, and also to see what treatments are most effective in relieving TMD pain and symptoms. |
Temporomandibular disorders (TMD) are a group of painful conditions involving the muscles of mastication and the temporomandibular joint. These pain problems are about twice as common in women as in men in the community, and prevalence peaks during the reproductive years. The etiology of TMD pain is unknown, but psychological stress, depression and the presence of other somatic complaints have been shown to influence the course of these disorders. Prior research suggests that female reproductive hormones may also influence TMD pain. Specifically, normally cycling women with TMD experience rising levels of TMD pain pre-menstrually during a time of precipitous drop in estrogen and show peak TMD pain during menses. Interestingly, a secondary peak of TMD pain occurs at about the time of ovulation, another phase corresponding to rapid estrogen change. These data demonstrate a systematic relationship between levels of TMD pain and phases of the menstrual cycle. The proposed clinical trial will manipulate the behavioral and hormonal factors that are hypothesized to influence TMD pain, comparing the effects of:
- a continuous oral contraceptive intervention designed to suppress menses and stabilize the hormonal environment;
- a self-management intervention focused on and timed to the chronobiology of TMD symptoms across the menstrual cycle; and
- a usual self-management intervention not timed to biological events. The aims of this clinical trial are to shed light on the mechanisms underlying the cyclic nature of TMD pain and symptoms in women, as well as to determine which treatment modality results in the greatest improvement in TMD pain and symptoms.
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| Interventional |
| Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study |
| Temporomandibular Joint Disorders |
| Behavioral: Cognitive-behavioral (2 arms) and pharmacologic (1 arm) |
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| Recruiting |
| 240 |
| December 2009 |
| December 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- TMD Pain Diagnosis as determined by enrollment exam at the University of Washington
- Menstruate on a regular basis
- Not planning to become pregnant during the next 6 months
Exclusion Criteria:
- Drug or alcohol abuse
- Current smoker and 35 years of age at any time during the study
- Live further than 1 hour driving distance from the University of Washington, Seattle campus
- Psychiatric disability
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| Female |
| 18 Years to 45 Years |
| No |
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| United States |
| |
| NCT00237042 |
| Dr. Linda LeResche, Principal Investigator, University of Washington |
| NIDCR-16212, 5R01-DE016212 |
| National Institute of Dental and Craniofacial Research (NIDCR) |
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| Principal Investigator: |
Linda LeResche |
University of Washington |
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| National Institute of Dental and Craniofacial Research (NIDCR) |
| May 2008 |