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Managing Temporomandibular Disorder (TMD) Symptoms
This study is currently recruiting participants.
Verified by National Institute of Dental and Craniofacial Research (NIDCR), May 2008
Sponsored by: National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by: National Institute of Dental and Craniofacial Research (NIDCR)
ClinicalTrials.gov Identifier: NCT00237042
  Purpose

The purpose of this study is to determine, in a population seeking treatment at a University-based clinic (University of Washington, Seattle, WA), what factors contribute to the cyclicity of TMD pain and symptoms in women, and also to see what treatments are most effective in relieving TMD pain and symptoms.


Condition Intervention
Temporomandibular Joint Disorders
Behavioral: Cognitive-behavioral (2 arms) and pharmacologic (1 arm)

MedlinePlus related topics: Joint Disorders Temporomandibular Joint Dysfunction
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study
Official Title: Hormonal Cycles in Women: Effects on TMD Pain & Symptoms

Further study details as provided by National Institute of Dental and Craniofacial Research (NIDCR):

Primary Outcome Measures:
  • Characteristic Pain Intensity [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain-Related Interference [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: October 2005
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Cognitive-behavioral (2 arms) and pharmacologic (1 arm)
    Factors contributing to the cyclicity of TMD pain and symptoms in women.
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

Contacts
Contact: Linda LeResche, DR 206-616-6049 leresche@u.washington.edu
Contact: Judith Turner, DR 206-543-3997 jturner@u.washington.edu

Locations
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195-6370
Contact: Linda LeResche     206-616-6049     leresche@u.washington.edu    
Contact: Judith Turner, DR     206-543-3997     jturner@u.washington.edu    
Principal Investigator: Linda LeResche            
Sponsors and Collaborators
Investigators
Principal Investigator: Linda LeResche University of Washington
  More Information

Responsible Party: University of Washington ( Dr. Linda LeResche, Principal Investigator )
Study ID Numbers: NIDCR-16212, 5R01-DE016212
Study First Received: October 7, 2005
Last Updated: May 14, 2008
ClinicalTrials.gov Identifier: NCT00237042  
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Dental and Craniofacial Research (NIDCR):
Temporomandibular Disorders
TMJ Disorders

Study placed in the following topic categories:
Temporomandibular Joint Disorders
Muscular Diseases
Musculoskeletal Diseases
Temporomandibular Joint Dysfunction Syndrome
Myofascial Pain Syndromes
Fibromyalgia
Craniomandibular Disorders
Joint Diseases
Pain
Stomatognathic Diseases

Additional relevant MeSH terms:
Mandibular Diseases
Pathologic Processes
Disease
Jaw Diseases

ClinicalTrials.gov processed this record on January 16, 2009