Managing Temporomandibular Disorder (TMD) Symptoms
This study is currently recruiting patients
Verified by National Institute of Dental and Craniofacial Research (NIDCR) April 2006
| 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 |
Behavior: Cognitive-behavioral (2 arms) and pharmacologic (1 arm) |
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, 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 Outcomes: Based on diaries: daily levels of TMD pain and severity of cyclic symptoms; global measures of TMD pain severity and pain related interference
Expected Total Enrollment:
240
Study start: October 2005;
Expected completion: December 2009
Last follow-up: June 2009;
Data entry closure: September 2009
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
-
45 Years,
Genders Eligible for Study:
Female
Criteria
Inclusion Criteria:
- New patients to the Oral Medicine Clinic, University of Washington, Seattle, WA.
- TMD pain diagnosis
- 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
Location
and Contact
Information
Please refer to this study by ClinicalTrials.gov identifier
NCT00237042
WashingtonUniversity of Washington, Seattle,
Washington,
98195-6370,
United States; Recruiting
Study chairs or principal investigators
Linda LeResche, Principal Investigator, University of Washington
More Information
Study ID Numbers:
NIDCR-16212; 5R01-DE016212
Last Updated:
June 8, 2006
Record first received:
October 7, 2005
ClinicalTrials.gov Identifier:
NCT00237042Health Authority: United States: Food and Drug Administration ClinicalTrials.gov processed this record on 2006-09-29 |
