Clinical trial NCT00237042: Managing Temporomandibular Disorder (TMD) Symptoms
Official title: Hormonal Cycles in Women: Effects on TMD Pain & Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Joint Disorders
Keywords: Temporomandibular Disorders
TMJ Disorders
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2005-10-12
Enrollment: 252
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Characteristic Pain Intensity (Characteristic Intensity of Facial Pain)
timeFrame: 6 months
measure: Characteristic Pain Intensity (Characteristic Intensity of Facial Pain)
timeFrame: 12 months
Secondary outcomes:
measure: Number of Participants With Pain-Related Activity Interference
timeFrame: 6 Months
measure: Number of Participants With Pain-Related Activity Interference
timeFrame: 12 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Linda LeResche
role: PRINCIPAL_INVESTIGATOR
References: