Managing Temporomandibular Disorder (TMD) Symptoms
Hormonal Cycles in Women: Effects on TMD Pain & Symptoms
4 other identifiers
interventional
252
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2005
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 7, 2005
CompletedFirst Posted
Study publicly available on registry
October 12, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedResults Posted
Study results publicly available
July 11, 2011
CompletedJuly 11, 2011
June 1, 2011
4.7 years
October 7, 2005
May 2, 2011
June 10, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Characteristic Pain Intensity (Characteristic Intensity of Facial Pain)
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.
6 months
Characteristic Pain Intensity (Characteristic Intensity of Facial Pain)
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.
12 months
Secondary Outcomes (2)
Number of Participants With Pain-Related Activity Interference
6 Months
Number of Participants With Pain-Related Activity Interference
12 months
Study Arms (3)
Self Management
ACTIVE COMPARATORDental hygienist-delivered pain self-management treatment
Targeted Self Management
EXPERIMENTALDental hygienist-delivered pain self-management treatment with a focus on menstrual cycle-related changes in pain and other symptoms
Continuous Oral Contraceptives
EXPERIMENTALOral contraceptive (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months with no "spacer pills."
Interventions
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.
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.
Combination pill (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Washington
Seattle, Washington, 98195-6370, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Judith Turner
- Organization
- University of Washington
Study Officials
- PRINCIPAL INVESTIGATOR
Linda LeResche
University of Washington
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 7, 2005
First Posted
October 12, 2005
Study Start
October 1, 2005
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
July 11, 2011
Results First Posted
July 11, 2011
Record last verified: 2011-06