Trial · NCT00066937

Comparison of Psychological and Pharmacological Treatments for Pain Due to Temporomandibular Joint Disorder (TMD)

NCT00066937, Phase 2, Completed, Johns Hopkins University; results first posted 2017-07-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Comparison of Psychological and Pharmacological Treatments for Pain Due to Temporomandibular Joint Disorder (TMD). Trials, record NCT00066937. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00066937

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Comparison of Psychological and Pharmacological Treatments for Pain Due to Temporomandibular Joint Disorder (TMD)
NCT number: NCT00066937
Status: Completed
Phases: Phase 2
Enrollment: 140 participants, actual
Lead sponsor: Johns Hopkins University
Conditions: Temporomandibular Joint Disorders
Interventions: Nortriptyline Oral Capsule, Benztropine Oral Product, CBT, Disease MGT
First posted: 2003-08-08
Last updated: 2017-07-24
Results first posted: 2017-07-24

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Average Pain	baseline, post-treatment, 3 months, 6 months	0 (no pain) to 10 (pain as bad as could be) rating of average pain during the past week; higher scores indicate greater pain
Primary	Change in Pain-related Interference	baseline, post-treatment, 3 months, 6 months	Multidimensional 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
Secondary	Worst Pain	baseline, post-treatment, 3 months, 6 months	0 (no pain) to 10 (pain as bad as could be) rating of worst pain during the past week
Secondary	Mental Health as Assessed by the Short Form 36 Healthy Survey	baseline, post-treatment, 3 months, 6 months	The 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).

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Average Pain	baseline, post-treatment, 3 months, 6 months	units on a scale	MEAN
PRIMARY	Change in Pain-related Interference	baseline, post-treatment, 3 months, 6 months	Change in scores on a scale	MEAN
SECONDARY	Worst Pain	baseline, post-treatment, 3 months, 6 months	units on a scale	MEAN
SECONDARY	Mental Health as Assessed by the Short Form 36 Healthy Survey	baseline, post-treatment, 3 months, 6 months	units on a scale	MEAN

Source ClinicalTrials.gov

Results by group60

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Average Pain	Nortriptyline Oral Capsule/CBT	baseline	4.7	Standard Deviation 2.2	units on a scale
Average Pain	Benztropine Oral Product/CBT	baseline	4.4	Standard Deviation 2.1	units on a scale
Average Pain	Nortriptyline Oral Capsule/Disease MGT	baseline	4.5	Standard Deviation 2.2	units on a scale
Average Pain	Benztropine Oral Product/Disease MGT	baseline	5.0	Standard Deviation 1.8	units on a scale
Average Pain	Nortriptyline Oral Capsule/CBT	post treatment	2.8	Standard Deviation 2.6	units on a scale
Average Pain	Benztropine Oral Product/CBT	post treatment	2.7	Standard Deviation 2.1	units on a scale
Average Pain	Nortriptyline Oral Capsule/Disease MGT	post treatment	2.0	Standard Deviation 1.4	units on a scale
Average Pain	Benztropine Oral Product/Disease MGT	post treatment	2.8	Standard Deviation 2.1	units on a scale
Average Pain	Nortriptyline Oral Capsule/CBT	3 months	2.1	Standard Deviation 1.6	units on a scale
Average Pain	Benztropine Oral Product/CBT	3 months	2.4	Standard Deviation 2.2	units on a scale

1 to 10 of 60Source ClinicalTrials.gov

See all 60 results by group

Participant flow36

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Treatment Phase	STARTED	Nortriptyline Oral Capsule/CBT	41
Treatment Phase	STARTED	Benztropine Oral Product/CBT	38
Treatment Phase	STARTED	Nortriptyline Oral Capsule/Disease MGT	37
Treatment Phase	STARTED	Benztropine Oral Product/Disease MGT	24
Treatment Phase	COMPLETED	Nortriptyline Oral Capsule/CBT	38
Treatment Phase	COMPLETED	Benztropine Oral Product/CBT	33
Treatment Phase	COMPLETED	Nortriptyline Oral Capsule/Disease MGT	26
Treatment Phase	COMPLETED	Benztropine Oral Product/Disease MGT	19
Treatment Phase	NOT COMPLETED	Nortriptyline Oral Capsule/CBT	3
Treatment Phase	NOT COMPLETED	Benztropine Oral Product/CBT	5

1 to 10 of 36Source ClinicalTrials.gov

See all 36 participant flow

Adverse events12

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	drymouth	General disorders	Nortriptyline Oral Capsule/CBT	20	41
other	drymouth	General disorders	Benztropine Oral Product/CBT	14	38
other	drymouth	General disorders	Nortriptyline Oral Capsule/Disease MGT	13	37
other	drymouth	General disorders	Benztropine Oral Product/Disease MGT	9	24
other	sedation	Nervous system disorders	Nortriptyline Oral Capsule/CBT	7	41
other	sedation	Nervous system disorders	Benztropine Oral Product/CBT	8	38
other	sedation	Nervous system disorders	Nortriptyline Oral Capsule/Disease MGT	7	37
other	sedation	Nervous system disorders	Benztropine Oral Product/Disease MGT	3	24
other	constipation	Gastrointestinal disorders	Nortriptyline Oral Capsule/CBT	10	41
other	constipation	Gastrointestinal disorders	Benztropine Oral Product/CBT	7	38

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Nortriptyline Oral Capsule/CBT	0	41
Total, all-cause mortality	Benztropine Oral Product/CBT	0	38
Total, all-cause mortality	Nortriptyline Oral Capsule/Disease MGT	0	37
Total, all-cause mortality	Benztropine Oral Product/Disease MGT	0	24
Total, other adverse events	Nortriptyline Oral Capsule/CBT	32	41
Total, other adverse events	Benztropine Oral Product/CBT	24	38
Total, other adverse events	Nortriptyline Oral Capsule/Disease MGT	21	37
Total, other adverse events	Benztropine Oral Product/Disease MGT	15	24
Total, serious adverse events	Nortriptyline Oral Capsule/CBT	0	41
Total, serious adverse events	Benztropine Oral Product/CBT	0	38

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01DE013906	Pain Management in Temporomandibular Joint Disorders	HAYTHORNTHWAITE, JENNIFER A	JOHNS HOPKINS UNIVERSITY	NATIONAL INSTITUTE OF DENTAL &CRANIOFACIAL RESEARCH	2001 to 2005

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00066937

GET https://conductscience.org/api/trials/v1/NCT00066937/results?page=2

API reference For AI assistants