Temporomandibular Joint Disorders
Conditions
Keywords
Temporomandibular Disorders, TMJ Disorders
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.
Interventions
BEHAVIORALSelf 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.
BEHAVIORALTargeted 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.
DRUG20 mcg ethinyl estradiol and 100 mcg levonorgestrel
Combination pill (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months.
Sponsors
National Institute of Dental and Craniofacial Research (NIDCR)
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Characteristic Pain Intensity (Characteristic Intensity of Facial Pain) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Pain-Related Activity Interference | 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 |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 51 |
| 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. | 47 |
| 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. | 49 |
| Total | 147 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Long Term (12 Month) Follow up | Lost to Follow-up | 11 | 9 | 9 |
| Short Term (6 Month) Follow up | Lost to Follow-up | 9 | 8 | 11 |
| Treatment | Became ineligible post-randomization | 0 | 1 | 16 |
| Treatment | Completed no treatment | 5 | 5 | 21 |
| Treatment | Moved out of state | 1 | 1 | 1 |
Baseline characteristics
| Characteristic | Continuous Oral Contraceptives | Total | Self Management | Targeted Self Management |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 49 Participants | 147 Participants | 51 Participants | 47 Participants |
| Age Continuous | 28.6 years STANDARD_DEVIATION 6.9 | 27.8 years STANDARD_DEVIATION 6.9 | 29.1 years STANDARD_DEVIATION 7.4 | 25.4 years STANDARD_DEVIATION 5.7 |
| Region of Enrollment United States | 49 participants | 147 participants | 51 participants | 47 participants |
| Sex: Female, Male Female | 49 Participants | 147 Participants | 51 Participants | 47 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 54 | 0 / 50 | 23 / 36 |
| serious Total, serious adverse events | 0 / 54 | 0 / 50 | 0 / 36 |
Outcome results
Primary
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.
Time frame: 6 months
Population: Participants with 6 month follow up data. Intention to treat analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self Management | Characteristic Pain Intensity (Characteristic Intensity of Facial Pain) | 3.1 units on a scale | Standard Deviation 1.8 |
| Targeted Self Management | Characteristic Pain Intensity (Characteristic Intensity of Facial Pain) | 2.9 units on a scale | Standard Deviation 2 |
| Continuous Oral Contraceptives | Characteristic Pain Intensity (Characteristic Intensity of Facial Pain) | 3.6 units on a scale | Standard Deviation 2.2 |
Comparison: The null hypothesis was that mean characteristic pain intensity at 6-month follow up is equal across the three groups.p-value: 0.19Regression, Linear
Primary
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.
Time frame: 12 months
Population: Participants with 12 month follow up data. Intention to treat analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self Management | Characteristic Pain Intensity (Characteristic Intensity of Facial Pain) | 2.8 Units on a scale | Standard Deviation 1.6 |
| Targeted Self Management | Characteristic Pain Intensity (Characteristic Intensity of Facial Pain) | 2.8 Units on a scale | Standard Deviation 2 |
| Continuous Oral Contraceptives | Characteristic Pain Intensity (Characteristic Intensity of Facial Pain) | 3.9 Units on a scale | Standard Deviation 1.9 |
Comparison: The null hypothesis was that mean characteristic pain intensity at 12-month follow up is equal across the three groups.p-value: 0.003Regression, Linear
Secondary
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
Time frame: 6 Months
Population: Participants with 6 month follow up data. Intention to treat analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Self Management | Number of Participants With Pain-Related Activity Interference | 21 participants |
| Targeted Self Management | Number of Participants With Pain-Related Activity Interference | 19 participants |
| Continuous Oral Contraceptives | Number of Participants With Pain-Related Activity Interference | 25 participants |
p-value: 0.27Regression, Logistic
Secondary
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
Time frame: 12 months
Population: Participants with 12 month follow up data. Intention to treat analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Self Management | Number of Participants With Pain-Related Activity Interference | 19 participants |
| Targeted Self Management | Number of Participants With Pain-Related Activity Interference | 17 participants |
| Continuous Oral Contraceptives | Number of Participants With Pain-Related Activity Interference | 30 participants |
p-value: 0.016Regression, Logistic