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Trial record 3 of 16 for:    Temporomandibular Joint Disorders | NIH

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

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ClinicalTrials.gov Identifier: NCT00066937
Recruitment Status : Completed
First Posted : August 8, 2003
Results First Posted : July 24, 2017
Last Update Posted : July 24, 2017
Sponsor:
Collaborator:
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE August 7, 2003
First Posted Date  ICMJE August 8, 2003
Results First Submitted Date April 17, 2017
Results First Posted Date July 24, 2017
Last Update Posted Date July 24, 2017
Study Start Date  ICMJE November 2002
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 21, 2017)
  • Average Pain [ Time Frame: 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
  • Change in Pain-related Interference [ Time Frame: 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
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00066937 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2017)
  • Worst Pain [ Time Frame: 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
  • Mental Health as Assessed by the Short Form 36 Healthy Survey [ Time Frame: 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).
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Psychological and Pharmacological Treatments for Pain Due to Temporomandibular Joint Disorder (TMD)
Official Title  ICMJE Pain Management in Temporomandibular Joint Disorders
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.
Detailed Description This is a randomized, controlled trial evaluating pharmacological (nortriptyline vs. active placebo - benztropine) and psychological (cognitive-behavioral therapy vs. disease education) treatments for pain and disability due to temporomandibular joint disorder (TMD). Patients 18 to 65 years old meeting RDC criteria for TMD and other eligibility criteria complete a 3-week baseline monitoring phase prior to randomization. Active treatment consists of weekly visits for 8 week, then maintenance treatment for 6 months. Outcome measures include pain, physical and psychosocial function and are assessed at post-treatment, 3-months, and 6-months
Study Type  ICMJE Interventional
Study Phase Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Temporomandibular Joint Disorders
Intervention  ICMJE
  • Drug: Nortriptyline Oral Capsule
    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.
  • Drug: Benztropine Oral Product
    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.
  • Behavioral: CBT
    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.
  • Behavioral: Disease MGT
    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.
Study Arms
  • Experimental: Nortriptyline Oral Capsule/CBT
    Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of CBT.
    Interventions:
    • Drug: Nortriptyline Oral Capsule
    • Behavioral: CBT
  • Experimental: 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.
    Interventions:
    • Drug: Benztropine Oral Product
    • Behavioral: CBT
  • Experimental: 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.
    Interventions:
    • Drug: Nortriptyline Oral Capsule
    • Behavioral: Disease MGT
  • Active Comparator: 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.
    Interventions:
    • Drug: Benztropine Oral Product
    • Behavioral: Disease MGT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 21, 2017)
140
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
214
Actual Study Completion Date July 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion:

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

Exclusion:

  • 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00066937
Other Study ID Numbers  ICMJE RPN 00-03-21-02
R01DE013906 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE National Institute of Dental and Craniofacial Research (NIDCR)
Investigators  ICMJE
Principal Investigator: Jennifer A Haythornthwaite, Ph.D Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP