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Managing Temporomandibular Disorder (TMD) Symptoms
This study is currently recruiting participants.
Study NCT00237042   Information provided by National Institute of Dental and Craniofacial Research (NIDCR)
First Received: October 7, 2005   Last Updated: May 14, 2008   History of Changes

October 7, 2005
May 14, 2008
October 2005
December 2009   (final data collection date for primary outcome measure)
Characteristic Pain Intensity [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • Based on diaries:
  • Daily levels of TMD pain and severity of cyclic symptoms. Global measures of TMD pain severity and pain related interference.
Complete list of historical versions of study NCT00237042 on ClinicalTrials.gov Archive Site
Pain-Related Interference [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
Same as current
 
Managing Temporomandibular Disorder (TMD) Symptoms
Hormonal Cycles in Women: Effects on TMD Pain & Symptoms

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.

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.
 
Interventional
Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study
Temporomandibular Joint Disorders
Behavioral: Cognitive-behavioral (2 arms) and pharmacologic (1 arm)
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
240
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Female
18 Years to 45 Years
No
Contact: Linda LeResche, DR 206-616-6049 leresche@u.washington.edu
Contact: Judith Turner, DR 206-543-3997 jturner@u.washington.edu
United States
 
NCT00237042
Dr. Linda LeResche, Principal Investigator, University of Washington
NIDCR-16212, 5R01-DE016212
National Institute of Dental and Craniofacial Research (NIDCR)
 
Principal Investigator: Linda LeResche University of Washington
National Institute of Dental and Craniofacial Research (NIDCR)
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP