At a glance
ClinicalIndex Comparison Record- ✓Confirmed TMD pain diagnosis from enrollment exam at University of Washington
- ✓Menstruates on a regular basis
- ✓Not planning pregnancy in next 6 months
- ✕History of drug or alcohol abuse
- ✕Current smoker aged 35 or older at any time during study
- ✕Lives >1 hour driving distance from University of Washington Seattle campus
- ✕Psychiatric disability
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Hormonal Cycles in Women: Effects on TMD Pain & Symptoms
In Brief
A clinical study evaluating Self Management, Targeted Self Management, and 1 other intervention for Temporomandibular Joint Disorders. Completed, enrolled 252 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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 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.
Combination pill (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months.