Managing Temporomandibular Disorder (TMD) Symptoms

NCT ID: NCT00237042

Last Updated: 2011-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 252 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2010-06-30

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.

Conditions

Temporomandibular Joint Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Self Management

Dental hygienist-delivered pain self-management treatment

Group Type: ACTIVE_COMPARATOR

Self Management

Intervention Type: BEHAVIORAL

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.

Targeted Self Management

Dental hygienist-delivered pain self-management treatment with a focus on menstrual cycle-related changes in pain and other symptoms

Group Type: EXPERIMENTAL

Targeted Self Management

Intervention Type: BEHAVIORAL

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.

Continuous Oral Contraceptives

Oral contraceptive (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months with no "spacer pills."

Group Type: EXPERIMENTAL

20 mcg ethinyl estradiol and 100 mcg levonorgestrel

Intervention Type: DRUG

Combination pill (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

20 mcg ethinyl estradiol and 100 mcg levonorgestrel

Combination pill (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months.

Intervention Type: DRUG

Other Intervention Names

Aviane

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Dental and Craniofacial Research (NIDCR)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

University of Washington

Principal Investigators

Linda LeResche

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington

Seattle, Washington, United States

Countries

United States

Other Identifiers

R01DE016212

Identifier Type: NIH

Identifier Source: secondary_id

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5R01DE016212

Identifier Type: NIH

Identifier Source: secondary_id

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NIDCR-16212

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

27729-D

Identifier Type: -

Identifier Source: org_study_id