Managing Temporomandibular Disorder (TMD) Symptoms
This study has been completed.
Sponsor:
University of Washington
Collaborator:
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00237042
First received: October 7, 2005
Last updated: June 10, 2011
Last verified: June 2011
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Temporomandibular Joint Disorders |
Behavioral: Self Management Behavioral: Targeted Self Management Drug: 20 mcg ethinyl estradiol and 100 mcg levonorgestrel |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Hormonal Cycles in Women: Effects on TMD Pain & Symptoms |
Resource links provided by NLM:
Drug Information available for:
Estradiol
Ethinyl Estradiol
Estradiol cypionate
Levonorgestrel
Estradiol valerate
Estradiol acetate
Estradiol hemihydrate
U.S. FDA Resources
Further study details as provided by University of Washington:
Primary Outcome Measures:
- Characteristic Pain Intensity (Characteristic Intensity of Facial Pain) [ Time Frame: 6 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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:
- Number of Participants With Pain-Related Activity Interference [ Time Frame: 6 Months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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
| Enrollment: | 252 |
| Study Start Date: | October 2005 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00237042
Locations
| United States, Washington | |
| University of Washington | |
| Seattle, Washington, United States, 98195-6370 | |
Sponsors and Collaborators
University of Washington
Investigators
| Principal Investigator: | Linda LeResche | University of Washington |
More Information
No publications provided
| Responsible Party: | Dr. Linda LeResche, Principal Investigator, University of Washington |
| ClinicalTrials.gov Identifier: | NCT00237042 History of Changes |
| Other Study ID Numbers: | 27729-D, R01DE016212, 5R01-DE016212, NIDCR-16212 |
| Study First Received: | October 7, 2005 |
| Results First Received: | May 2, 2011 |
| Last Updated: | June 10, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Washington:
|
Temporomandibular Disorders TMJ Disorders |
Additional relevant MeSH terms:
|
Joint Diseases Temporomandibular Joint Disorders Temporomandibular Joint Dysfunction Syndrome Musculoskeletal Diseases Craniomandibular Disorders Mandibular Diseases Jaw Diseases Muscular Diseases Stomatognathic Diseases Myofascial Pain Syndromes Contraceptives, Oral Levonorgestrel Estradiol Polyestradiol phosphate |
Ethinyl Estradiol Estradiol valerate Estradiol 3-benzoate Estradiol 17 beta-cypionate Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptives, Oral, Synthetic |
ClinicalTrials.gov processed this record on May 16, 2013