NCT00066937

Brief Summary

The purpose of this study is to determine whether the combination of cognitive-behavioral treatment and nortriptyline are more effective than each treatment alone in reducing the pain and disability associated with TMD.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2002

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 8, 2003

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
9.1 years until next milestone

Results Posted

Study results publicly available

July 24, 2017

Completed
Last Updated

July 24, 2017

Status Verified

July 1, 2017

Enrollment Period

5.6 years

First QC Date

August 7, 2003

Results QC Date

April 17, 2017

Last Update Submit

July 21, 2017

Conditions

Temporomandibular Joint Disorders

Outcome Measures

Primary Outcomes (2)

  • Average Pain

    0 (no pain) to 10 (pain as bad as could be) rating of average pain during the past week; higher scores indicate greater pain

    baseline, post-treatment, 3 months, 6 months

  • Change in Pain-related Interference

    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

    baseline, post-treatment, 3 months, 6 months

Secondary Outcomes (2)

  • Worst Pain

    baseline, post-treatment, 3 months, 6 months

  • Mental Health as Assessed by the Short Form 36 Healthy Survey

    baseline, post-treatment, 3 months, 6 months

Study Arms (4)

Nortriptyline Oral Capsule/CBT

EXPERIMENTAL

Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of CBT.

Drug: Nortriptyline Oral CapsuleBehavioral: CBT

Benztropine Oral Product/CBT

EXPERIMENTAL

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.

Drug: Benztropine Oral ProductBehavioral: CBT

Nortriptyline Oral Capsule/Disease MGT

EXPERIMENTAL

Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of TMD disease management.

Drug: Nortriptyline Oral CapsuleBehavioral: Disease MGT

Benztropine Oral Product/Disease MGT

ACTIVE COMPARATOR

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.

Drug: Benztropine Oral ProductBehavioral: Disease MGT

Interventions

Nortriptyline Oral CapsuleDRUG

Nortriptyline will be titrated up from 25 mg qhs to a maximum dose of 150 mg qhs based on treatment response and side effect profile.

Nortriptyline Oral Capsule/CBTNortriptyline Oral Capsule/Disease MGT
Benztropine Oral ProductDRUG

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.

Benztropine Oral Product/CBTBenztropine Oral Product/Disease MGT
CBTBEHAVIORAL

Six in-person, individual sessions of cognitive-behavioral therapy for pain management include relaxation training, pain coping skills training, cognitive therapy for negative and dysfunctional thoughts, and diaries for monitoring relaxation, goals, and negative thinking.

Benztropine Oral Product/CBTNortriptyline Oral Capsule/CBT
Disease MGTBEHAVIORAL

Six in-person, individual sessions of temporomandibular joint disorder (TMD) disease management (MGT) that include information about the jaw and good oral habits, diet, sleep, and general stress management.

Benztropine Oral Product/Disease MGTNortriptyline Oral Capsule/Disease MGT

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>= 18 and \<= 65
  • Pain \>= 3 months duration due to temporomandibular joint disorder
  • Pain due to TMD is primary if other pain conditions present

You may not qualify if:

  • Continuous, chronic painful non-reducing disc displacement of TMJ and patient can't open mouth
  • Unstable or acute severe pain from another pain condition
  • Patient is pregnant
  • Presence of a medical condition that contraindicates nortriptyline: angle-closure glaucoma,symptomatic orthosis
  • EKG: first degree heart block or QTc \> 450 msec
  • Unstable angina or a history of a myocardial infarction within the past 3 months
  • Current treatment with an antidepressant which cannot be withdrawn
  • Current use of a medication that interacts with nortriptyline to raise blood levels, such as selective serotonin reuptake inhibitors (e.g.,paroxetine), systemic anti-fungal agents (fluconazole), antiarrhythmics (e.g., quinidine), antipsychotics (e.g., haloperidol), and antibiotics (e.g., erythromycin).
  • Presence of dementia, psychosis or other disorder of cognition that impairs ability to participate in minimal contact intervention
  • Beck Depression Inventory (BDI) score \>= 35 OR BDI Item #9 (suicide item) is scored \> 1
  • Patient has a terminal illness with a life expectancy of less than six months
  • History of arthrotomy of temporomandibular joint
  • History of allergic reaction to nortriptyline or benztropine
  • History of a therapeutic trial with nortriptyline (dose \>= 100 mg for at least 3 weeks)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland, Dental School

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Nortriptyline

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

DibenzocycloheptenesBenzocycloheptenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Results Point of Contact

Title
Jennifer Haythornthwaite
Organization
Johns Hopkins University
jhaytho1@jhmi.edu
410-550-7985

Study Officials

  • Jennifer A Haythornthwaite, Ph.D

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2003

First Posted

August 8, 2003

Study Start

November 1, 2002

Primary Completion

June 1, 2008

Study Completion

July 1, 2008

Last Updated

July 24, 2017

Results First Posted

July 24, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)