- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01475630
Physical Therapy for Temporomandibular Joint (TMJ) Closed Lock
November 21, 2011 updated by: prof.dr. Antoon De Laat, KU Leuven
Randomised Controlled Trial on Physical Therapy PT) for TMJ Closed Lock
The aim of the present study was to investigate the effect of Physical Therapy (PT) on pain and mandibular function in patients with anterior disc displacement without reduction (ADD-R) or "closed lock" of the TMJ and this in a randomized controlled trial design.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study evaluated the effect of extra, technical PT over the traditional information on the benign nature of the disease and the advice to refrain from overuse or misuse of the masticatory system as in parafunctions.
Study Type
Interventional
Enrollment (Actual)
49
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Leuven, Belgium, B-3000
- univ hospital sint Rafael, KULeuven
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- All patients were recruited from the Oral Pain and Dysfunction Clinic and strictly satisfied the RDC-TMD criteria for .for disc displacement without reduction with (group IIb) or without (group IIc) limitation of mouth opening, based upon history and clinical examination. Additionally, pain experienced during the first examination had to be ≥ 35mm on a visual analog scale (VAS) of 100mm.
Exclusion Criteria:
- Patients were excluded if their medical history mentioned orofacial traumata (contusion or fracture), systemic disorders (e.g. rheumatoid arthritis, fibromyalgia), cervical disorders (operationalized as complaints, pain or referral patterns of pain provoked during movements of the cervical spine), neurologic disorders (e.g. trigeminal neuralgia, migraine or tension type headache), drug or alcohol abuse, use of antidepressant or hormonal medication. Participants did not receive therapy for symptoms of TMD within the last 2 months.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: control
information, avoiding parafunctions
|
relaxation
Other Names:
|
|
Experimental: physical therapy
mobilisation, exercises ,..
|
mobilisation of the jaw, exercises, boostering information on avoiding parafunctions
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pain intensity
Time Frame: 1 year
|
using VAS scales
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
mouth opening
Time Frame: 1 year
|
interincisal dstance measured by a ruler upon active and passive mouth opening
|
1 year
|
|
pressure pain threshold
Time Frame: 1 year
|
the pressure pain threshold was measured using an algometer at the masseter and temporalis muscles bilaterally
|
1 year
|
|
mandibular function impairment questionnaire
Time Frame: 1 year
|
Using a validated questionnaire the impact of the pain and limitaiton on normal masticatory function is monitored
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Antoon De Laat, DDS,PhD, Catholic University Leuven
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2003
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
November 1, 2011
Study Registration Dates
First Submitted
November 17, 2011
First Submitted That Met QC Criteria
November 18, 2011
First Posted (Estimate)
November 21, 2011
Study Record Updates
Last Update Posted (Estimate)
November 22, 2011
Last Update Submitted That Met QC Criteria
November 21, 2011
Last Verified
November 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ML2210
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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