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Trial record 5 of 14 for:    Temporomandibular Joint Disorders | NIH

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

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition: Temporomandibular Joint Disorders
Interventions: Behavioral: Self Management
Behavioral: Targeted Self Management
Drug: 20 mcg ethinyl estradiol and 100 mcg levonorgestrel

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruited 10/05-06/09. Study participants were recruited from patients seeking care at the University of Washington Orofacial Pain Clinic and by advertising.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Run-in period: Study participants completed daily diaries of pain and other symptoms for one menstrual cycle prior to randomization. Only participants who returned completed diaries for at least 85% of the requested days were eligible for randomization. 191/252 enrolled subjects were randomized.

Reporting Groups
  Description
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.
Targeted Self Management Self management as described for the first arm. 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.
Continuous Oral Contraceptives 20 mcg ethinyl estradiol and 100 mcg levonorgestrel Combination pill (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months.

Participant Flow for 3 periods

Period 1:   Treatment
    Self Management   Targeted Self Management   Continuous Oral Contraceptives
STARTED   60   57   74 
COMPLETED   54   50   36 
NOT COMPLETED   6   7   38 
Became ineligible post-randomization                0                1                16 
Moved out of state                1                1                1 
Completed no treatment                5                5                21 

Period 2:   Short Term (6 Month) Follow up
    Self Management   Targeted Self Management   Continuous Oral Contraceptives
STARTED   59 [1]   55 [1]   57 [1] 
COMPLETED   50   47   46 
NOT COMPLETED   9   8   11 
Lost to Follow-up                9                8                11 
[1] Greater than number completing treatment: intent to treat analysis

Period 3:   Long Term (12 Month) Follow up
    Self Management   Targeted Self Management   Continuous Oral Contraceptives
STARTED   59 [1]   55 [1]   57 [1] 
COMPLETED   48   46   48 
NOT COMPLETED   11   9   9 
Lost to Follow-up                11                9                9 
[1] Greater than number completing treatment: intent to treat analysis



  Baseline Characteristics


  Outcome Measures

1.  Primary:   Characteristic Pain Intensity (Characteristic Intensity of Facial Pain)   [ Time Frame: 6 months ]

2.  Primary:   Characteristic Pain Intensity (Characteristic Intensity of Facial Pain)   [ Time Frame: 12 months ]

3.  Secondary:   Number of Participants With Pain-Related Activity Interference   [ Time Frame: 6 Months ]

4.  Secondary:   Number of Participants With Pain-Related Activity Interference   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Judith Turner
Organization: University of Washington
phone: 206-543-3997
e-mail: jturner@u.washington.edu



Responsible Party: Dr. Linda LeResche, Principal Investigator, University of Washington
ClinicalTrials.gov Identifier: NCT00237042     History of Changes
Other Study ID Numbers: 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) )
First Submitted: October 7, 2005
First Posted: October 12, 2005
Results First Submitted: May 2, 2011
Results First Posted: July 11, 2011
Last Update Posted: July 11, 2011