Managing Temporomandibular Disorder (TMD) Symptoms - Full Text View

Sponsor:	University of Washington
Collaborator:	National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by:	University of Washington
ClinicalTrials.gov Identifier:	NCT00237042

Purpose

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.

Condition	Intervention
Temporomandibular Joint Disorders	Behavioral: Self Management Behavioral: Targeted Self Management Drug: 20 mcg ethinyl estradiol and 100 mcg levonorgestrel

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Hormonal Cycles in Women: Effects on TMD Pain & Symptoms

Resource links provided by NLM:

MedlinePlus related topics: Joint Disorders Menstruation Temporomandibular Joint Dysfunction

Drug Information available for: Estradiol Estradiol 3-benzoate Ethinyl estradiol Polyestradiol phosphate Depogen Estradiol dipropionate Estradiol cypionate Levonorgestrel Estradiol valerate Estradiol acetate

U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:

Characteristic Pain Intensity (Characteristic Intensity of Facial Pain) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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 [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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

Enrollment:	252
Study Start Date:	October 2005
Study Completion Date:	June 2010
Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Self Management Dental hygienist-delivered pain self-management treatment	Behavioral: Self Management 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.
Experimental: Targeted Self Management Dental hygienist-delivered pain self-management treatment with a focus on menstrual cycle-related changes in pain and other symptoms	Behavioral: Targeted Self Management 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.
Experimental: Continuous Oral Contraceptives Oral contraceptive (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months with no "spacer pills."	Drug: 20 mcg ethinyl estradiol and 100 mcg levonorgestrel Combination pill (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months. Other Name: Aviane

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

Locations

United States, Washington
University of Washington
Seattle, Washington, United States, 98195-6370

Sponsors and Collaborators

University of Washington

National Institute of Dental and Craniofacial Research (NIDCR)

Investigators

Principal Investigator:

Linda LeResche

University of Washington

More Information

No publications provided

Responsible Party:	Dr. Linda LeResche, Principal Investigator, University of Washington
ClinicalTrials.gov Identifier:	NCT00237042 History of Changes
Other Study ID Numbers:	27729-D, R01DE016212, 5R01-DE016212, NIDCR-16212
Study First Received:	October 7, 2005
Results First Received:	May 2, 2011
Last Updated:	June 10, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Washington:

Temporomandibular Disorders
TMJ Disorders

Additional relevant MeSH terms:

Joint Diseases
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Musculoskeletal Diseases
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes
Contraceptives, Oral
Levonorgestrel
Estradiol
Polyestradiol phosphate

Ethinyl Estradiol
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptives, Oral, Synthetic

ClinicalTrials.gov processed this record on February 13, 2012