Managing Temporomandibular Disorder (TMD) Symptoms

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Temporomandibular Joint Disorders

Intervention / Treatment
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* Behavioral: Self Management
* Behavioral: Targeted Self Management
* Drug: 20 mcg ethinyl estradiol and 100 mcg levonorgestrel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Self Management<br>Dental hygienist-delivered pain self-management treatment | Behavioral: Self Management<br>* Two 1.5-hour in-person sessions and 6 10-15-minute telephone calls delivered by a dental hygienist, trained and supervised by a clinical psychologist. Structured, manual-based treatment based on standard cognitive-behavioral pain therapies and self-management interventions for chronic TMD pain. Sessions included education about the biopsychosocial model of chronic pain, TMD etiology and treatments, and the rationale for self-management; relaxation and stress management training; discussion of the role of stress and emotions as potential factors exacerbating and maintaining TMD symptoms; instruction and practice in self-monitoring of symptoms to identify factors that might be helpful to modify through self-care methods; practice of dentist-prescribed self-care treatments; and discussion of strategies to maintain gains and prevent relapse.<br>|
| Experimental: Targeted Self Management<br>Dental hygienist-delivered pain self-management treatment with a focus on menstrual cycle-related changes in pain and other symptoms | Behavioral: Targeted Self Management<br>* Self management as described above. However, the intervention also included education about the potential effects of hormones on TMD pain, instructions to monitor the association of pain and other symptoms with menstrual cycle changes, and planning for times in participants' menstrual cycles when symptoms might increase. Participant contacts were timed according to each participant's menstrual cycle.<br>|
| Experimental: Continuous Oral Contraceptives<br>Oral contraceptive (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months with no spacer pills. | Drug: 20 mcg ethinyl estradiol and 100 mcg levonorgestrel<br>* Combination pill (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months.<br>* Other names: Aviane;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characteristic Pain Intensity (Characteristic Intensity of Facial Pain) | 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. | 6 months | 
| Characteristic Pain Intensity (Characteristic Intensity of Facial Pain) | 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Pain-Related Activity Interference | 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 | 6 Months | 
| Number of Participants With Pain-Related Activity Interference | 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 | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Temporomandibular Disorders, TMJ Disorders