Managing Temporomandibular Disorder (TMD) Symptoms

Not Applicable

Completed

• Conditions: Temporomandibular Joint Disorders
• Interventions: Drug: 20 mcg ethinyl estradiol and 100 mcg levonorgestrel; Behavioral: Self Management; Behavioral: Targeted Self Management

• Registration Number: NCT00237042
• Lead Sponsor: University of Washington

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.

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2005-10-07
• Study First Submitted QC: 2005-10-07
• Study First Posted: 2005-10-12
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Results First Submitted: 2011-05-02
• Status Verified: 2011-06
• Results First Submitted QC: 2011-06-10
• Last Update Submitted: 2011-06-10
• Results First Posted: 2011-07-11
• Last Update Posted: 2011-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 252

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous Oral Contraceptives	20 mcg ethinyl estradiol and 100 mcg levonorgestrel	Oral contraceptive (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months with no "spacer pills."
Self Management	Self Management	Dental hygienist-delivered pain self-management treatment
Targeted Self Management	Targeted Self Management	Dental hygienist-delivered pain self-management treatment with a focus on menstrual cycle-related changes in pain and other symptoms

Primary Outcome Measures

Name	Time	Method
Characteristic Pain Intensity (Characteristic Intensity of Facial Pain)	12 months	Average of 0-10 ratings of current facial pain, average facial pain in the last month and worst facial pain in the last month, where 0 is no pain and 10 is pain as bad as could be. For the combined outcome, the minimum score is 0 and maximum is 10, with 0 being better (no pain) and 10 being the worst outcome.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Pain-Related Activity Interference	12 months	Degree to which pain interferes with: daily activities, work and household activities, recreational activities (mean of 3 0-10 ratings); dichotomized as presence/absence of pain-related activity interference

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States