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Managing Temporomandibular Disorder (TMD) Symptoms

Information source: University of Washington
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Temporomandibular Joint Disorders

Intervention: Self Management (Behavioral); Targeted Self Management (Behavioral); 20 mcg ethinyl estradiol and 100 mcg levonorgestrel (Drug)

Phase: N/A

Status: Completed

Sponsored by: University of Washington

Official(s) and/or principal investigator(s):
Linda LeResche, Principal Investigator, Affiliation: University of Washington

Summary

The purpose of this study is to determine whether treatments targeted to the hormonal factors and the cyclicity of TMD symptoms associated with the menstrual cycle are more effective in relieving TMD pain and symptoms than standard self management treatment.

Clinical Details

Official title: Hormonal Cycles in Women: Effects on TMD Pain & Symptoms

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome:

Characteristic Pain Intensity (Characteristic Intensity of Facial Pain)

Characteristic Pain Intensity (Characteristic Intensity of Facial Pain)

Secondary outcome:

Number of Participants With Pain-Related Activity Interference

Number of Participants With Pain-Related Activity Interference

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.

Criteria:

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

Locations and Contacts

University of Washington, Seattle, Washington 98195-6370, United States
Additional Information

Starting date: October 2005
Last updated: June 10, 2011

Page last updated: August 23, 2015

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