Trial Outcomes & Findings for Comparison of Psychological and Pharmacological Treatments for Pain Due to Temporomandibular Joint Disorder (TMD) (NCT NCT00066937)
NCT ID: NCT00066937
Last Updated: 2017-07-24
Results Overview
0 (no pain) to 10 (pain as bad as could be) rating of average pain during the past week; higher scores indicate greater pain
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
140 participants
Primary outcome timeframe
baseline, post-treatment, 3 months, 6 months
Results posted on
2017-07-24
Participant Flow
Participant milestones
| Measure |
Nortriptyline Oral Capsule/CBT
Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of CBT.
|
Benztropine Oral Product/CBT
Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of CBT.
|
Nortriptyline Oral Capsule/Disease MGT
Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of TMD disease management.
|
Benztropine Oral Product/Disease MGT
Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of TMD disease management.
|
|---|---|---|---|---|
|
Treatment Phase
STARTED
|
41
|
38
|
37
|
24
|
|
Treatment Phase
COMPLETED
|
38
|
33
|
26
|
19
|
|
Treatment Phase
NOT COMPLETED
|
3
|
5
|
11
|
5
|
|
3 Month Follow-up
STARTED
|
38
|
33
|
26
|
19
|
|
3 Month Follow-up
COMPLETED
|
33
|
32
|
25
|
15
|
|
3 Month Follow-up
NOT COMPLETED
|
5
|
1
|
1
|
4
|
|
6 Month Follow-up
STARTED
|
33
|
32
|
25
|
15
|
|
6 Month Follow-up
COMPLETED
|
26
|
29
|
22
|
14
|
|
6 Month Follow-up
NOT COMPLETED
|
7
|
3
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Psychological and Pharmacological Treatments for Pain Due to Temporomandibular Joint Disorder (TMD)
Baseline characteristics by cohort
| Measure |
Nortriptyline Oral Capsule/CBT
n=41 Participants
Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of CBT.
|
Benztropine Oral Product/CBT
n=38 Participants
Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of CBT.
|
Nortriptyline Oral Capsule/Disease MGT
n=37 Participants
Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of TMD disease management.
|
Benztropine Oral Product/Disease MGT
n=24 Participants
Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of TMD disease management.
|
Total
n=140 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
35.7 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
38.4 years
STANDARD_DEVIATION 12.5 • n=7 Participants
|
37.2 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
33.3 years
STANDARD_DEVIATION 11.3 • n=4 Participants
|
36.4 years
STANDARD_DEVIATION 11.9 • n=21 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
105 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=5 Participants
|
38 participants
n=7 Participants
|
37 participants
n=5 Participants
|
24 participants
n=4 Participants
|
140 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: baseline, post-treatment, 3 months, 6 months0 (no pain) to 10 (pain as bad as could be) rating of average pain during the past week; higher scores indicate greater pain
Outcome measures
| Measure |
Nortriptyline Oral Capsule/CBT
n=38 Participants
Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of CBT.
|
Benztropine Oral Product/CBT
n=33 Participants
Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of CBT.
|
Nortriptyline Oral Capsule/Disease MGT
n=26 Participants
Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of TMD disease management.
|
Benztropine Oral Product/Disease MGT
n=19 Participants
Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of TMD disease management.
|
|---|---|---|---|---|
|
Average Pain
baseline
|
4.7 units on a scale
Standard Deviation 2.2
|
4.4 units on a scale
Standard Deviation 2.1
|
4.5 units on a scale
Standard Deviation 2.2
|
5.0 units on a scale
Standard Deviation 1.8
|
|
Average Pain
post treatment
|
2.8 units on a scale
Standard Deviation 2.6
|
2.7 units on a scale
Standard Deviation 2.1
|
2.0 units on a scale
Standard Deviation 1.4
|
2.8 units on a scale
Standard Deviation 2.1
|
|
Average Pain
3 months
|
2.1 units on a scale
Standard Deviation 1.6
|
2.4 units on a scale
Standard Deviation 2.2
|
2.2 units on a scale
Standard Deviation 2.1
|
2.5 units on a scale
Standard Deviation 2.1
|
|
Average Pain
6 months
|
2.0 units on a scale
Standard Deviation 1.7
|
2.0 units on a scale
Standard Deviation 2.1
|
1.4 units on a scale
Standard Deviation 1.6
|
2.2 units on a scale
Standard Deviation 2.5
|
PRIMARY outcome
Timeframe: baseline, post-treatment, 3 months, 6 monthsMultidimensional Pain Inventory: Pain interference subscale score; average score computed from 12 items rated on scale from 0=no interference to 6=extreme interference; higher scores indicate greater pain-related interference
Outcome measures
| Measure |
Nortriptyline Oral Capsule/CBT
n=38 Participants
Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of CBT.
|
Benztropine Oral Product/CBT
n=33 Participants
Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of CBT.
|
Nortriptyline Oral Capsule/Disease MGT
n=26 Participants
Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of TMD disease management.
|
Benztropine Oral Product/Disease MGT
n=19 Participants
Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of TMD disease management.
|
|---|---|---|---|---|
|
Change in Pain-related Interference
Change in score from baseline to post-treatment
|
0.9 Change in scores on a scale
Standard Deviation 0.9
|
0.5 Change in scores on a scale
Standard Deviation 0.9
|
0.5 Change in scores on a scale
Standard Deviation 0.7
|
1.0 Change in scores on a scale
Standard Deviation 0.9
|
|
Change in Pain-related Interference
Change in score from baseline to 3 months
|
0.8 Change in scores on a scale
Standard Deviation 0.9
|
0.8 Change in scores on a scale
Standard Deviation 0.9
|
1.0 Change in scores on a scale
Standard Deviation 0.9
|
1.1 Change in scores on a scale
Standard Deviation 1.2
|
|
Change in Pain-related Interference
Change in score from baseline to 6 months
|
0.8 Change in scores on a scale
Standard Deviation 0.8
|
0.7 Change in scores on a scale
Standard Deviation 1.2
|
0.7 Change in scores on a scale
Standard Deviation 0.8
|
0.8 Change in scores on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: baseline, post-treatment, 3 months, 6 months0 (no pain) to 10 (pain as bad as could be) rating of worst pain during the past week
Outcome measures
| Measure |
Nortriptyline Oral Capsule/CBT
n=38 Participants
Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of CBT.
|
Benztropine Oral Product/CBT
n=33 Participants
Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of CBT.
|
Nortriptyline Oral Capsule/Disease MGT
n=26 Participants
Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of TMD disease management.
|
Benztropine Oral Product/Disease MGT
n=19 Participants
Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of TMD disease management.
|
|---|---|---|---|---|
|
Worst Pain
baseline
|
6.7 units on a scale
Standard Deviation 2.3
|
6.1 units on a scale
Standard Deviation 2.2
|
6.3 units on a scale
Standard Deviation 2.4
|
7.2 units on a scale
Standard Deviation 1.9
|
|
Worst Pain
post-treatment
|
4.0 units on a scale
Standard Deviation 2.9
|
4.1 units on a scale
Standard Deviation 2.8
|
3.2 units on a scale
Standard Deviation 2.1
|
4.4 units on a scale
Standard Deviation 2.6
|
|
Worst Pain
3 months
|
3.6 units on a scale
Standard Deviation 2.4
|
3.3 units on a scale
Standard Deviation 2.3
|
3.4 units on a scale
Standard Deviation 2.7
|
4.1 units on a scale
Standard Deviation 2.9
|
|
Worst Pain
6 months
|
3.3 units on a scale
Standard Deviation 2.1
|
3.1 units on a scale
Standard Deviation 2.7
|
2.7 units on a scale
Standard Deviation 2.2
|
3.4 units on a scale
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: baseline, post-treatment, 3 months, 6 monthsThe Mental Health Component score from the Short Form (36) Health Survey, which is a 36-item, patient-reported survey of patient health. The mental health component score is calculated from responses to the general health, mental health, vitality, physical and emotional role limitations, and social functioning subscales, with higher scores indicating better mental health. The scale ranges from zero (equivalent to maximum disability) to 100 (no disability).
Outcome measures
| Measure |
Nortriptyline Oral Capsule/CBT
n=38 Participants
Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of CBT.
|
Benztropine Oral Product/CBT
n=33 Participants
Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of CBT.
|
Nortriptyline Oral Capsule/Disease MGT
n=26 Participants
Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of TMD disease management.
|
Benztropine Oral Product/Disease MGT
n=19 Participants
Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of TMD disease management.
|
|---|---|---|---|---|
|
Mental Health as Assessed by the Short Form 36 Healthy Survey
baseline
|
50.5 units on a scale
Standard Deviation 8.1
|
49.2 units on a scale
Standard Deviation 9.3
|
51.2 units on a scale
Standard Deviation 8.8
|
48.0 units on a scale
Standard Deviation 8.9
|
|
Mental Health as Assessed by the Short Form 36 Healthy Survey
post-treatment
|
50.8 units on a scale
Standard Deviation 10.4
|
48.4 units on a scale
Standard Deviation 8.1
|
52.6 units on a scale
Standard Deviation 10.0
|
53.3 units on a scale
Standard Deviation 10.6
|
|
Mental Health as Assessed by the Short Form 36 Healthy Survey
3 months
|
51.5 units on a scale
Standard Deviation 8.9
|
50.2 units on a scale
Standard Deviation 8.7
|
52.6 units on a scale
Standard Deviation 10.0
|
53.8 units on a scale
Standard Deviation 10.1
|
|
Mental Health as Assessed by the Short Form 36 Healthy Survey
6 months
|
52.2 units on a scale
Standard Deviation 7.8
|
53.3 units on a scale
Standard Deviation 12.8
|
52.3 units on a scale
Standard Deviation 7.2
|
53.6 units on a scale
Standard Deviation 7.3
|
Adverse Events
Nortriptyline Oral Capsule/CBT
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
Benztropine Oral Product/CBT
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Nortriptyline Oral Capsule/Disease MGT
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Benztropine Oral Product/Disease MGT
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nortriptyline Oral Capsule/CBT
n=41 participants at risk
Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of CBT.
|
Benztropine Oral Product/CBT
n=38 participants at risk
Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of CBT.
|
Nortriptyline Oral Capsule/Disease MGT
n=37 participants at risk
Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of TMD disease management.
|
Benztropine Oral Product/Disease MGT
n=24 participants at risk
Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of TMD disease management.
|
|---|---|---|---|---|
|
General disorders
drymouth
|
48.8%
20/41 • Adverse event data were collected weekly during the treatment phase, then at 3- and 6-months
|
36.8%
14/38 • Adverse event data were collected weekly during the treatment phase, then at 3- and 6-months
|
35.1%
13/37 • Adverse event data were collected weekly during the treatment phase, then at 3- and 6-months
|
37.5%
9/24 • Adverse event data were collected weekly during the treatment phase, then at 3- and 6-months
|
|
Nervous system disorders
sedation
|
17.1%
7/41 • Adverse event data were collected weekly during the treatment phase, then at 3- and 6-months
|
21.1%
8/38 • Adverse event data were collected weekly during the treatment phase, then at 3- and 6-months
|
18.9%
7/37 • Adverse event data were collected weekly during the treatment phase, then at 3- and 6-months
|
12.5%
3/24 • Adverse event data were collected weekly during the treatment phase, then at 3- and 6-months
|
|
Gastrointestinal disorders
constipation
|
24.4%
10/41 • Adverse event data were collected weekly during the treatment phase, then at 3- and 6-months
|
18.4%
7/38 • Adverse event data were collected weekly during the treatment phase, then at 3- and 6-months
|
24.3%
9/37 • Adverse event data were collected weekly during the treatment phase, then at 3- and 6-months
|
16.7%
4/24 • Adverse event data were collected weekly during the treatment phase, then at 3- and 6-months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place