Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
National Institute of Dental and Craniofacial Research (NIDCR) |
---|---|
Information provided by: | National Institute of Dental and Craniofacial Research (NIDCR) |
ClinicalTrials.gov Identifier: | NCT00237042 |
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.
Condition | Intervention |
---|---|
Temporomandibular Joint Disorders |
Behavioral: Cognitive-behavioral (2 arms) and pharmacologic (1 arm) |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Hormonal Cycles in Women: Effects on TMD Pain & Symptoms |
Estimated Enrollment: | 240 |
Study Start Date: | October 2005 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
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:
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Linda LeResche, DR | 206-616-6049 | leresche@u.washington.edu |
Contact: Judith Turner, DR | 206-543-3997 | jturner@u.washington.edu |
United States, Washington | |
University of Washington | Recruiting |
Seattle, Washington, United States, 98195-6370 | |
Contact: Linda LeResche 206-616-6049 leresche@u.washington.edu | |
Contact: Judith Turner, DR 206-543-3997 jturner@u.washington.edu | |
Principal Investigator: Linda LeResche |
Principal Investigator: | Linda LeResche | University of Washington |
Responsible Party: | University of Washington ( Dr. Linda LeResche, Principal Investigator ) |
Study ID Numbers: | NIDCR-16212, 5R01-DE016212 |
Study First Received: | October 7, 2005 |
Last Updated: | May 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00237042 |
Health Authority: | United States: Food and Drug Administration |
Temporomandibular Disorders TMJ Disorders |
Temporomandibular Joint Disorders Muscular Diseases Musculoskeletal Diseases Temporomandibular Joint Dysfunction Syndrome Myofascial Pain Syndromes |
Fibromyalgia Craniomandibular Disorders Joint Diseases Pain Stomatognathic Diseases |
Mandibular Diseases Pathologic Processes Disease Jaw Diseases |