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Trial record 5 of 15 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
Enrollment 252

Recruitment Details 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 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.
Arm/Group Title Self Management Targeted Self Management Continuous Oral Contraceptives
Hide Arm/Group 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. 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. 20 mcg ethinyl estradiol and 100 mcg levonorgestrel Combination pill (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months.
Period Title: Treatment
Started 60 57 74
Completed 54 50 36
Not Completed 6 7 38
Reason Not Completed
Became ineligible post-randomization             0             1             16
Moved out of state             1             1             1
Completed no treatment             5             5             21
Period Title: Short Term (6 Month) Follow up
Started 59 [1] 55 [1] 57 [1]
Completed 50 47 46
Not Completed 9 8 11
Reason Not Completed
Lost to Follow-up             9             8             11
[1]
Greater than number completing treatment: intent to treat analysis
Period Title: Long Term (12 Month) Follow up
Started 59 [1] 55 [1] 57 [1]
Completed 48 46 48
Not Completed 11 9 9
Reason Not Completed
Lost to Follow-up             11             9             9
[1]
Greater than number completing treatment: intent to treat analysis
Arm/Group Title Self Management Targeted Self Management Continuous Oral Contraceptives Total
Hide Arm/Group 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. 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. 20 mcg ethinyl estradiol and 100 mcg levonorgestrel Combination pill (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months. Total of all reporting groups
Overall Number of Baseline Participants 51 47 49 147
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 47 participants 49 participants 147 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
51
 100.0%
47
 100.0%
49
 100.0%
147
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 51 participants 47 participants 49 participants 147 participants
29.1  (7.4) 25.4  (5.7) 28.6  (6.9) 27.8  (6.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 47 participants 49 participants 147 participants
Female
51
 100.0%
47
 100.0%
49
 100.0%
147
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 51 participants 47 participants 49 participants 147 participants
51 47 49 147
1.Primary Outcome
Title Characteristic Pain Intensity (Characteristic Intensity of Facial Pain)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with 6 month follow up data. Intention to treat analysis.
Arm/Group Title Self Management Targeted Self Management Continuous Oral Contraceptives
Hide Arm/Group 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.
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.
20 mcg ethinyl estradiol and 100 mcg levonorgestrel Combination pill (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months.
Overall Number of Participants Analyzed 50 47 46
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.1  (1.8) 2.9  (2.0) 3.6  (2.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Self Management, Targeted Self Management, Continuous Oral Contraceptives
Comments The null hypothesis was that mean characteristic pain intensity at 6-month follow up is equal across the three groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.19
Comments [Not Specified]
Method Regression, Linear
Comments Linear regression was used to compare group means at follow up, adjusted for baseline values of the outcome variable.
2.Primary Outcome
Title Characteristic Pain Intensity (Characteristic Intensity of Facial Pain)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with 12 month follow up data. Intention to treat analysis.
Arm/Group Title Self Management Targeted Self Management Continuous Oral Contraceptives
Hide Arm/Group 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.
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.
20 mcg ethinyl estradiol and 100 mcg levonorgestrel Combination pill (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months.
Overall Number of Participants Analyzed 48 46 48
Mean (Standard Deviation)
Unit of Measure: Units on a scale
2.8  (1.6) 2.8  (2.0) 3.9  (1.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Self Management, Targeted Self Management, Continuous Oral Contraceptives
Comments The null hypothesis was that mean characteristic pain intensity at 12-month follow up is equal across the three groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Regression, Linear
Comments Group means compared with linear regression adjusted for baseline values. Adjusted difference: -1.0 between SMT and COCT, -1.0 between TSMT and COCT.
3.Secondary Outcome
Title Number of Participants With Pain-Related Activity Interference
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with 6 month follow up data. Intention to treat analysis.
Arm/Group Title Self Management Targeted Self Management Continuous Oral Contraceptives
Hide Arm/Group 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.
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.
20 mcg ethinyl estradiol and 100 mcg levonorgestrel Combination pill (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months.
Overall Number of Participants Analyzed 50 47 46
Measure Type: Number
Unit of Measure: participants
21 19 25
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Self Management, Targeted Self Management, Continuous Oral Contraceptives
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.27
Comments [Not Specified]
Method Regression, Logistic
Comments Adjusted for baseline value of the outcome variable
4.Secondary Outcome
Title Number of Participants With Pain-Related Activity Interference
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with 12 month follow up data. Intention to treat analysis.
Arm/Group Title Self Management Targeted Self Management Continuous Oral Contraceptives
Hide Arm/Group 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.
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.
20 mcg ethinyl estradiol and 100 mcg levonorgestrel Combination pill (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months.
Overall Number of Participants Analyzed 48 46 48
Measure Type: Number
Unit of Measure: participants
19 17 30
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Self Management, Targeted Self Management, Continuous Oral Contraceptives
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.016
Comments [Not Specified]
Method Regression, Logistic
Comments Adjusted for baseline value of the outcome variable
Time Frame Treatment period (6 months, all groups) and 2 months after treatment for continuous oral contraceptive group.
Adverse Event Reporting Description Subjects in the continuous oral contraceptive group were told to report any problems to the nurse practitioner.
 
Arm/Group Title Self Management Targeted Self Management Continuous Oral Contraceptives
Hide Arm/Group 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. 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. 20 mcg ethinyl estradiol and 100 mcg levonorgestrel Combination pill (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months.
All-Cause Mortality
Self Management Targeted Self Management Continuous Oral Contraceptives
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Self Management Targeted Self Management Continuous Oral Contraceptives
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/54 (0.00%)      0/50 (0.00%)      0/36 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Self Management Targeted Self Management Continuous Oral Contraceptives
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/54 (0.00%)      0/50 (0.00%)      23/36 (63.89%)    
General disorders       
Moodiness/increased emotionality *  0/54 (0.00%)  0 0/50 (0.00%)  0 3/36 (8.33%)  3
Weight gain * [1]  0/54 (0.00%)  0 0/50 (0.00%)  0 2/36 (5.56%)  2
Nervous system disorders       
Headaches * [1]  0/54 (0.00%)  0 0/50 (0.00%)  0 3/36 (8.33%)  3
Reproductive system and breast disorders       
Breakthrough bleeding * [2]  0/54 (0.00%)  0 0/50 (0.00%)  0 17/36 (47.22%)  20
Breast tenderness * [1]  0/54 (0.00%)  0 0/50 (0.00%)  0 3/36 (8.33%)  3
Cramping * [1]  0/54 (0.00%)  0 0/50 (0.00%)  0 2/36 (5.56%)  2
Skin and subcutaneous tissue disorders       
Acne * [3]  0/54 (0.00%)  0 0/50 (0.00%)  0 3/36 (8.33%)  3
*
Indicates events were collected by non-systematic assessment
[1]
Expected event with use of oral contraceptives
[2]
Expected event with onset of use of continuous oral contraceptives
[3]
Expected adverse event with use of oral contraceptives
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
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