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

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

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.

Baseline Measures

	Self Management	Targeted Self Management	Continuous Oral Contraceptives	Total
Number of Participants   [units: participants]	51	47	49	147
Age   [units: participants]
<=18 years	0	0	0	0
Between 18 and 65 years	51	47	49	147
>=65 years	0	0	0	0
Age   [units: years] Mean ± Standard Deviation	29.1  ± 7.4	25.4  ± 5.7	28.6  ± 6.9	27.8  ± 6.9
Gender   [units: participants]
Female	51	47	49	147
Male	0	0	0	0
Region of Enrollment   [units: participants]
United States	51	47	49	147

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 ]