Managing Temporomandibular Disorder (TMD) Symptoms
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|ClinicalTrials.gov Identifier: NCT00237042|
Recruitment Status : Completed
First Posted : October 12, 2005
Results First Posted : July 11, 2011
Last Update Posted : July 11, 2011
|Condition or disease||Intervention/treatment|
|Temporomandibular Joint Disorders||Behavioral: Self Management Behavioral: Targeted Self Management Drug: 20 mcg ethinyl estradiol and 100 mcg levonorgestrel|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||252 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Hormonal Cycles in Women: Effects on TMD Pain & Symptoms|
|Study Start Date :||October 2005|
|Primary Completion Date :||June 2010|
|Study Completion Date :||June 2010|
Active Comparator: Self Management
Dental hygienist-delivered pain self-management treatment
Behavioral: Self Management
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.
Experimental: Targeted Self Management
Dental hygienist-delivered pain self-management treatment with a focus on menstrual cycle-related changes in pain and other symptoms
Behavioral: Targeted Self Management
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.
Experimental: Continuous Oral Contraceptives
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
Combination pill (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months.
Other Name: Aviane
- Characteristic Pain Intensity (Characteristic Intensity of Facial Pain) [ Time Frame: 6 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.
- Characteristic Pain Intensity (Characteristic Intensity of Facial Pain) [ Time Frame: 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.
- Number of Participants With Pain-Related Activity Interference [ Time Frame: 6 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
- Number of Participants With Pain-Related Activity Interference [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00237042
|United States, Washington|
|University of Washington|
|Seattle, Washington, United States, 98195-6370|
|Principal Investigator:||Linda LeResche||University of Washington|