NCT00067366

Brief Summary

Temporomandibular Disorder (TMD) is a widespread chronic pain condition. Successful psychosocial treatments for TMD have been developed, but the mechanisms by which these treatments achieve their effects are not well known. The goal of this project is to evaluate the possible mechanisms responsible for treatment gains in TMD treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2003

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 19, 2003

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2003

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

August 1, 2017

Status Verified

July 1, 2017

Enrollment Period

5 years

First QC Date

August 15, 2003

Last Update Submit

July 27, 2017

Conditions

Outcome Measures

Primary Outcomes (3)

  • Pain

    Multidimensional pain ratings collected in person every 3 months

    Every 3 months out to 12 months

  • Pain-related interference with functioning

    Multidimensional function ratings collected in person every 3 months

    every 3 months out to 12 months

  • Depressive symptoms

    CES-D depressive symtpoms scale administered in perosn every 3 months.

    Every 3 months out to 12 months

Study Arms (2)

Coping Skills Training

EXPERIMENTAL

manualized coping skills training delivered along with conservative care

Behavioral: Cognitive-Behavioral treatment

Standard Care

ACTIVE COMPARATOR

Attention and life counseling added to Standard conservative care

Behavioral: Attention and lifestyle counseling

Interventions

Cognitive-Behavioral skills training for chronic pain

Coping Skills Training

Attention and lifestyle counseling added to Standard Care

Standard Care

Eligibility Criteria

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

You may qualify if:

  • Complaining of chronic TM-related pain for at least 3 months
  • Positive Axis I diagnosis on the Research Diagnostic Criteria (RDC) for temporomandibular disorders (positive on at least one Group), and may have no contraindications to TMD treatment
  • Fluency in English

You may not qualify if:

  • No previous surgery for treatment of TMD pain
  • No history of rheumatoid disease
  • No extensive anatomical destruction or deterioration of the TM joint
  • Not diagnosed as having pain of neuropathic or odontogenic origin
  • Not carrying a diagnosis of psychosis
  • No current treatment for depression
  • Not taking narcotic pain medication
  • Not pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

MeSH Terms

Conditions

Temporomandibular Joint Dysfunction SyndromeFibromyalgiaFacial Pain

Condition Hierarchy (Ancestors)

Temporomandibular Joint DisordersCraniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesMyofascial Pain SyndromesStomatognathic DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mark D Litt, Ph.D.

    UConn Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 15, 2003

First Posted

August 19, 2003

Study Start

October 1, 2003

Primary Completion

October 1, 2008

Study Completion

September 1, 2011

Last Updated

August 1, 2017

Record last verified: 2017-07

Locations