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Managing Temporomandibular Disorder (TMD) Symptoms

Primary Purpose

Temporomandibular Joint Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Self Management
Targeted Self Management
20 mcg ethinyl estradiol and 100 mcg levonorgestrel
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Joint Disorders focused on measuring Temporomandibular Disorders, TMJ Disorders

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Self Management

Targeted Self Management

Continuous Oral Contraceptives

Arm Description

Dental hygienist-delivered pain self-management treatment

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Number of Participants With Pain-Related Activity Interference
Degree to which pain interferes with: daily activities, work and household activities, recreational activities (mean of 3 0-10 ratings); dichotomized as presence/absence of pain-related activity interference
Number of Participants With Pain-Related Activity Interference
Degree to which pain interferes with: daily activities, work and household activities, recreational activities (mean of 3 0-10 ratings); dichotomized as presence/absence of pain-related activity interference

Full Information

First Posted
October 7, 2005
Last Updated
June 10, 2011
Sponsor
University of Washington
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
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1. Study Identification

Unique Protocol Identification Number
NCT00237042
Brief Title
Managing Temporomandibular Disorder (TMD) Symptoms
Official Title
Hormonal Cycles in Women: Effects on TMD Pain & Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Washington
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Disorders
Keywords
Temporomandibular Disorders, TMJ Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
252 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Self Management
Arm Type
Active Comparator
Arm Description
Dental hygienist-delivered pain self-management treatment
Arm Title
Targeted Self Management
Arm Type
Experimental
Arm Description
Dental hygienist-delivered pain self-management treatment with a focus on menstrual cycle-related changes in pain and other symptoms
Arm Title
Continuous Oral Contraceptives
Arm Type
Experimental
Arm Description
Oral contraceptive (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months with no "spacer pills."
Intervention Type
Behavioral
Intervention Name(s)
Self Management
Intervention Description
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
Intervention Name(s)
Targeted Self Management
Intervention Description
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
Drug
Intervention Name(s)
20 mcg ethinyl estradiol and 100 mcg levonorgestrel
Other Intervention Name(s)
Aviane
Intervention Description
Combination pill (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months.
Primary Outcome Measure Information:
Title
Characteristic Pain Intensity (Characteristic Intensity of Facial Pain)
Description
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.
Time Frame
6 months
Title
Characteristic Pain Intensity (Characteristic Intensity of Facial Pain)
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Number of Participants With Pain-Related Activity Interference
Description
Degree to which pain interferes with: daily activities, work and household activities, recreational activities (mean of 3 0-10 ratings); dichotomized as presence/absence of pain-related activity interference
Time Frame
6 Months
Title
Number of Participants With Pain-Related Activity Interference
Description
Degree to which pain interferes with: daily activities, work and household activities, recreational activities (mean of 3 0-10 ratings); dichotomized as presence/absence of pain-related activity interference
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda LeResche
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195-6370
Country
United States

12. IPD Sharing Statement

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Managing Temporomandibular Disorder (TMD) Symptoms

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