Trial Outcomes & Findings for Managing Temporomandibular Disorder (TMD) Symptoms (NCT NCT00237042)
NCT ID: NCT00237042
Last Updated: 2011-07-11
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
252 participants
Primary outcome timeframe
6 months
Results posted on
2011-07-11
Participant Flow
Recruited 10/05-06/09. Study participants were recruited from patients seeking care at the University of Washington Orofacial Pain Clinic and by advertising.
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.
Participant milestones
| Measure |
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.
|
|---|---|---|---|
|
Treatment
STARTED
|
60
|
57
|
74
|
|
Treatment
COMPLETED
|
54
|
50
|
36
|
|
Treatment
NOT COMPLETED
|
6
|
7
|
38
|
|
Short Term (6 Month) Follow up
STARTED
|
59
|
55
|
57
|
|
Short Term (6 Month) Follow up
COMPLETED
|
50
|
47
|
46
|
|
Short Term (6 Month) Follow up
NOT COMPLETED
|
9
|
8
|
11
|
|
Long Term (12 Month) Follow up
STARTED
|
59
|
55
|
57
|
|
Long Term (12 Month) Follow up
COMPLETED
|
48
|
46
|
48
|
|
Long Term (12 Month) Follow up
NOT COMPLETED
|
11
|
9
|
9
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|---|
|
Treatment
Became ineligible post-randomization
|
0
|
1
|
16
|
|
Treatment
Moved out of state
|
1
|
1
|
1
|
|
Treatment
Completed no treatment
|
5
|
5
|
21
|
|
Short Term (6 Month) Follow up
Lost to Follow-up
|
9
|
8
|
11
|
|
Long Term (12 Month) Follow up
Lost to Follow-up
|
11
|
9
|
9
|
Baseline Characteristics
Managing Temporomandibular Disorder (TMD) Symptoms
Baseline characteristics by cohort
| Measure |
Self Management
n=51 Participants
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
n=47 Participants
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
n=49 Participants
20 mcg ethinyl estradiol and 100 mcg levonorgestrel Combination pill (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months.
|
Total
n=147 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
51 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
147 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age Continuous
|
29.1 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
25.4 years
STANDARD_DEVIATION 5.7 • n=7 Participants
|
28.6 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
27.8 years
STANDARD_DEVIATION 6.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
147 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
51 participants
n=5 Participants
|
47 participants
n=7 Participants
|
49 participants
n=5 Participants
|
147 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Participants with 6 month follow up data. Intention to treat analysis.
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.
Outcome measures
| Measure |
Self Management
n=50 Participants
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
n=47 Participants
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
n=46 Participants
20 mcg ethinyl estradiol and 100 mcg levonorgestrel Combination pill (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months.
|
|---|---|---|---|
|
Characteristic Pain Intensity (Characteristic Intensity of Facial Pain)
|
3.1 units on a scale
Standard Deviation 1.8
|
2.9 units on a scale
Standard Deviation 2.0
|
3.6 units on a scale
Standard Deviation 2.2
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Participants with 12 month follow up data. Intention to treat analysis.
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.
Outcome measures
| Measure |
Self Management
n=48 Participants
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
n=46 Participants
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
n=48 Participants
20 mcg ethinyl estradiol and 100 mcg levonorgestrel Combination pill (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months.
|
|---|---|---|---|
|
Characteristic Pain Intensity (Characteristic Intensity of Facial Pain)
|
2.8 Units on a scale
Standard Deviation 1.6
|
2.8 Units on a scale
Standard Deviation 2.0
|
3.9 Units on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: Participants with 6 month follow up data. Intention to treat analysis.
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
Outcome measures
| Measure |
Self Management
n=50 Participants
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
n=47 Participants
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
n=46 Participants
20 mcg ethinyl estradiol and 100 mcg levonorgestrel Combination pill (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months.
|
|---|---|---|---|
|
Number of Participants With Pain-Related Activity Interference
|
21 participants
|
19 participants
|
25 participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Participants with 12 month follow up data. Intention to treat analysis.
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
Outcome measures
| Measure |
Self Management
n=48 Participants
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
n=46 Participants
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
n=48 Participants
20 mcg ethinyl estradiol and 100 mcg levonorgestrel Combination pill (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months.
|
|---|---|---|---|
|
Number of Participants With Pain-Related Activity Interference
|
19 participants
|
17 participants
|
30 participants
|
Adverse Events
Self Management
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Targeted Self Management
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Continuous Oral Contraceptives
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Self Management
n=54 participants at risk
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
n=50 participants at risk
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
n=36 participants at risk
20 mcg ethinyl estradiol and 100 mcg levonorgestrel Combination pill (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/54 • Treatment period (6 months, all groups) and 2 months after treatment for continuous oral contraceptive group.
Subjects in the continuous oral contraceptive group were told to report any problems to the nurse practitioner.
|
0.00%
0/50 • Treatment period (6 months, all groups) and 2 months after treatment for continuous oral contraceptive group.
Subjects in the continuous oral contraceptive group were told to report any problems to the nurse practitioner.
|
8.3%
3/36 • Number of events 3 • Treatment period (6 months, all groups) and 2 months after treatment for continuous oral contraceptive group.
Subjects in the continuous oral contraceptive group were told to report any problems to the nurse practitioner.
|
|
Reproductive system and breast disorders
Breakthrough bleeding
|
0.00%
0/54 • Treatment period (6 months, all groups) and 2 months after treatment for continuous oral contraceptive group.
Subjects in the continuous oral contraceptive group were told to report any problems to the nurse practitioner.
|
0.00%
0/50 • Treatment period (6 months, all groups) and 2 months after treatment for continuous oral contraceptive group.
Subjects in the continuous oral contraceptive group were told to report any problems to the nurse practitioner.
|
47.2%
17/36 • Number of events 20 • Treatment period (6 months, all groups) and 2 months after treatment for continuous oral contraceptive group.
Subjects in the continuous oral contraceptive group were told to report any problems to the nurse practitioner.
|
|
Reproductive system and breast disorders
Breast tenderness
|
0.00%
0/54 • Treatment period (6 months, all groups) and 2 months after treatment for continuous oral contraceptive group.
Subjects in the continuous oral contraceptive group were told to report any problems to the nurse practitioner.
|
0.00%
0/50 • Treatment period (6 months, all groups) and 2 months after treatment for continuous oral contraceptive group.
Subjects in the continuous oral contraceptive group were told to report any problems to the nurse practitioner.
|
8.3%
3/36 • Number of events 3 • Treatment period (6 months, all groups) and 2 months after treatment for continuous oral contraceptive group.
Subjects in the continuous oral contraceptive group were told to report any problems to the nurse practitioner.
|
|
Reproductive system and breast disorders
Cramping
|
0.00%
0/54 • Treatment period (6 months, all groups) and 2 months after treatment for continuous oral contraceptive group.
Subjects in the continuous oral contraceptive group were told to report any problems to the nurse practitioner.
|
0.00%
0/50 • Treatment period (6 months, all groups) and 2 months after treatment for continuous oral contraceptive group.
Subjects in the continuous oral contraceptive group were told to report any problems to the nurse practitioner.
|
5.6%
2/36 • Number of events 2 • Treatment period (6 months, all groups) and 2 months after treatment for continuous oral contraceptive group.
Subjects in the continuous oral contraceptive group were told to report any problems to the nurse practitioner.
|
|
Nervous system disorders
Headaches
|
0.00%
0/54 • Treatment period (6 months, all groups) and 2 months after treatment for continuous oral contraceptive group.
Subjects in the continuous oral contraceptive group were told to report any problems to the nurse practitioner.
|
0.00%
0/50 • Treatment period (6 months, all groups) and 2 months after treatment for continuous oral contraceptive group.
Subjects in the continuous oral contraceptive group were told to report any problems to the nurse practitioner.
|
8.3%
3/36 • Number of events 3 • Treatment period (6 months, all groups) and 2 months after treatment for continuous oral contraceptive group.
Subjects in the continuous oral contraceptive group were told to report any problems to the nurse practitioner.
|
|
General disorders
Moodiness/increased emotionality
|
0.00%
0/54 • Treatment period (6 months, all groups) and 2 months after treatment for continuous oral contraceptive group.
Subjects in the continuous oral contraceptive group were told to report any problems to the nurse practitioner.
|
0.00%
0/50 • Treatment period (6 months, all groups) and 2 months after treatment for continuous oral contraceptive group.
Subjects in the continuous oral contraceptive group were told to report any problems to the nurse practitioner.
|
8.3%
3/36 • Number of events 3 • Treatment period (6 months, all groups) and 2 months after treatment for continuous oral contraceptive group.
Subjects in the continuous oral contraceptive group were told to report any problems to the nurse practitioner.
|
|
General disorders
Weight gain
|
0.00%
0/54 • Treatment period (6 months, all groups) and 2 months after treatment for continuous oral contraceptive group.
Subjects in the continuous oral contraceptive group were told to report any problems to the nurse practitioner.
|
0.00%
0/50 • Treatment period (6 months, all groups) and 2 months after treatment for continuous oral contraceptive group.
Subjects in the continuous oral contraceptive group were told to report any problems to the nurse practitioner.
|
5.6%
2/36 • Number of events 2 • Treatment period (6 months, all groups) and 2 months after treatment for continuous oral contraceptive group.
Subjects in the continuous oral contraceptive group were told to report any problems to the nurse practitioner.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place