Psychological PredictorsNCT01396694
An Evaluation of Psychological Parameters That May Influence the Outcome Following Arthroscopy and Arthroplasty for Temporomandibular Joint Surgery
An observational study of Psychological Predictors, run by Emory University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Psychological Predictors
- What is being tested?
- Questionnaire
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 18 yrs
Who may be able to join
- require arthroscopy or arthroplasty
Who cannot join
- age less than 18 yrs
- prior surgery
- unable to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 4 Study of the Influence of Psychological Factors on the Outcomes Following Arthroscopy and Arthroplasty for Temporomandibular Joint Dysfunction
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.
- Conditions
- Psychological Predictors
- Being tested
- Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Questionnaire
| Study group | Role | What they receive |
|---|---|---|
| all | All patients requiring arthroscopy or arthroplasty Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Pain will be recorded in a site specific matter (left and right TMJ) using a visual analogue scale
Measured: 3 months
Secondary outcomes (1)
Function
Function will be measured using the jaw function limitation scale which will assess overall jaw and masticatory function with a short well validated questionnaire
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2011 (estimated)
- Study startJun 2009
- Primary completionDec 2012
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological PredictorsStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gary F Bouloux MD, DDS, MDSc, FRACDS, FRACDS, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01396694
- Sponsor's protocol ID
- IRB00061869
- Status last verified
- Feb 2016
- First submitted
- 8 Jul 2011
- Last updated
- 17 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of the Influence of Psychological Factors on the Outcomes Following Arthroscopy and Arthroplasty for Temporomandibular Joint Dysfunction
- ClinicalTrials.gov ID
- NCT01396694
- Acronym / sponsor ID
- IRB00061869
- Conditions
- Psychological Predictors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 19 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| all | – | Other: QuestionnaireAll patients requiring arthroscopy or arthroplasty |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 18 yrs
Key inclusion criteria (1 listed)
- require arthroscopy or arthroplasty
Key exclusion criteria (3 listed)
- age less than 18 yrs
- prior surgery
- unable to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireQuestionnaire | Other | all |
Primary outcome
Pain
Time frame: 3 months
Pain will be recorded in a site specific matter (left and right TMJ) using a visual analogue scale
1 secondary outcome
Function
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychological Predictors, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2016.