Temporomandibular Joint DisordersNCT00237042
Managing Temporomandibular Disorder (TMD) Symptoms
A study testing Self Management, Targeted Self Management and 20 mcg ethinyl estradiol and 100 mcg levonorgestrel in people with Temporomandibular Joint Disorders, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Temporomandibular Joint Disorders
- What is being tested?
- Self Management, Targeted Self Management and 20 mcg ethinyl estradiol and 100 mcg levonorgestrel
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Jun 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington
Seattle, Washington, 98195-6370
About this study
Official title: Hormonal Cycles in Women: Effects on TMD Pain & Symptoms
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.
Read the 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.
- Conditions
- Temporomandibular Joint Disorders
- Being tested
- Self Management, Targeted Self Management, 20 mcg ethinyl estradiol and 100 mcg levonorgestrel
- Keywords
- Temporomandibular Disorders, TMJ Disorders
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self ManagementBehavioural
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 ManagementBehavioural
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.
20 mcg ethinyl estradiol and 100 mcg levonorgestrelDrug
Also called Aviane
Combination pill (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Self Management | Active comparator | Dental hygienist-delivered pain self-management treatment Receives: Behavioral: Self Management |
| Targeted Self Management | Experimental | Dental hygienist-delivered pain self-management treatment with a focus on menstrual cycle-related changes in pain and other symptoms Receives: Behavioral: Targeted Self Management |
| Continuous Oral Contraceptives | Experimental | Oral contraceptive (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months with no "spacer pills." Receives: Drug: 20 mcg ethinyl estradiol and 100 mcg levonorgestrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
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.
Measured: 12 months
Secondary outcomes (2)
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
Measured: 6 Months
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study startOct 2005
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Temporomandibular Joint DisordersStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Investigators
- Linda LeResche, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00237042
- Sponsor's protocol ID
- 27729-D
- Other IDs
- R01DE016212, 5R01DE016212, NIDCR-16212
- Status last verified
- Jun 2011
- First submitted
- 7 Oct 2005
- Last updated
- 11 Jul 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hormonal Cycles in Women: Effects on TMD Pain & Symptoms
- ClinicalTrials.gov ID
- NCT00237042
- Acronym / sponsor ID
- 27729-D
- Conditions
- Temporomandibular Joint Disorders
- Keywords
- Temporomandibular Disorders, TMJ Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- Oct 2005
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 12 Oct 2005 (estimated)
- Results
- Posted 11 Jul 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Self Management | Active comparator | Behavioral: Self ManagementDental hygienist-delivered pain self-management treatment |
| Targeted Self Management | Experimental | Behavioral: Targeted Self ManagementDental hygienist-delivered pain self-management treatment with a focus on menstrual cycle-related changes in pain and other symptoms |
| Continuous Oral Contraceptives | Experimental | Drug: 20 mcg ethinyl estradiol and 100 mcg levonorgestrelOral contraceptive (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months with no "spacer pills." |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self ManagementTwo 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. | Behavioural | Self Management |
| Targeted Self ManagementSelf 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. | Behavioural | Targeted Self Management |
| 20 mcg ethinyl estradiol and 100 mcg levonorgestrelAlso: AvianeCombination pill (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months. | Drug | Continuous Oral Contraceptives |
Primary outcome
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.
2 secondary outcomes
Number of Participants With Pain-Related Activity Interference
Time frame: 6 Months
Number of Participants With Pain-Related Activity Interference
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda LeResche principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self Management, Targeted Self Management and 20 mcg ethinyl estradiol and 100 mcg levonorgestrel in people with Temporomandibular Joint Disorders, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characteristic Pain Intensity (Characteristic Intensity of Facial Pain) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2011.