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Managing Temporomandibular Disorder (TMD) Symptoms

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ClinicalTrials.gov Identifier: NCT00237042
Recruitment Status : Completed
First Posted : October 12, 2005
Results First Posted : July 11, 2011
Last Update Posted : July 11, 2011
Sponsor:
Collaborator:
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by:
University of Washington

Tracking Information
First Submitted Date  ICMJE October 7, 2005
First Posted Date  ICMJE October 12, 2005
Results First Submitted Date  ICMJE May 2, 2011
Results First Posted Date  ICMJE July 11, 2011
Last Update Posted Date July 11, 2011
Study Start Date  ICMJE October 2005
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2011)
  • Characteristic Pain Intensity (Characteristic Intensity of Facial Pain) [ Time Frame: 6 months ]
    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 ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 7, 2005)
  • Based on diaries:
  • Daily levels of TMD pain and severity of cyclic symptoms. Global measures of TMD pain severity and pain related interference.
Change History Complete list of historical versions of study NCT00237042 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2011)
  • Number of Participants With Pain-Related Activity Interference [ Time Frame: 6 Months ]
    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 ]
    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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Managing Temporomandibular Disorder (TMD) Symptoms
Official Title  ICMJE Hormonal Cycles in Women: Effects on TMD Pain & Symptoms
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Temporomandibular Joint Disorders
Intervention  ICMJE
  • 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.
  • 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.
  • 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
Study Arms  ICMJE
  • Active Comparator: Self Management
    Dental hygienist-delivered pain self-management treatment
    Intervention: Behavioral: Self Management
  • Experimental: Targeted Self Management
    Dental hygienist-delivered pain self-management treatment with a focus on menstrual cycle-related changes in pain and other symptoms
    Intervention: Behavioral: Targeted Self Management
  • Experimental: Continuous Oral Contraceptives
    Oral contraceptive (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months with no "spacer pills."
    Intervention: Drug: 20 mcg ethinyl estradiol and 100 mcg levonorgestrel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 10, 2011)
252
Original Enrollment  ICMJE
 (submitted: October 7, 2005)
240
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00237042
Other Study ID Numbers  ICMJE 27729-D
R01DE016212 ( U.S. NIH Grant/Contract )
5R01DE016212 ( U.S. NIH Grant/Contract )
NIDCR-16212 ( Other Grant/Funding Number: National Institute of Dental and Craniofacial Research (NIDCR) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Linda LeResche, Principal Investigator, University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE National Institute of Dental and Craniofacial Research (NIDCR)
Investigators  ICMJE
Principal Investigator: Linda LeResche University of Washington
PRS Account University of Washington
Verification Date June 2011

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