Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

An Evaluation of Psychological Parameters That May Influence the Outcome Following Arthroscopy and Arthroplasty for Temporomandibular Joint Surgery

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Gary F Bouloux MD, DDS, MDSc, FRACDS, FRACDS, Emory University Identifier:
First received: July 8, 2011
Last updated: October 25, 2014
Last verified: October 2014

All patients undergoing arthroscopy or arthroplasty for temporomandibular joint dysfunction will complete a psychological questionnaire prior to surgery. The 3 month outcomes including pain and function will be examined using regression analysis to identify psychological variables that may predict outcomes.

Condition Intervention
Psychological Predictors
Other: Questionnaire

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Phase 4 Study of the Influence of Psychological Factors on the Outcomes Following Arthroscopy and Arthroplasty for Temporomandibular Joint Dysfunction

Further study details as provided by Emory University:

Primary Outcome Measures:
  • Pain [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Pain will be recorded in a site specific matter (left and right TMJ) using a visual analogue scale

Secondary Outcome Measures:
  • Function [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Function will be measured using the jaw function limitation scale which will assess overall jaw and masticatory function with a short well validated questionnaire

Enrollment: 105
Study Start Date: June 2009
Estimated Study Completion Date: December 2014
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
All patients requiring arthroscopy or arthroplasty
Other: Questionnaire


Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

18 yrs


Inclusion Criteria:

  • require arthroscopy or arthroplasty

Exclusion Criteria:

  • age less than 18 yrs
  • prior surgery
  • unable to give informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01396694

United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
  More Information

No publications provided

Responsible Party: Gary F Bouloux MD, DDS, MDSc, FRACDS, FRACDS, PI, Emory University Identifier: NCT01396694     History of Changes
Other Study ID Numbers: IRB00061869
Study First Received: July 8, 2011
Last Updated: October 25, 2014
Health Authority: United States: Institutional Review Board processed this record on February 27, 2015