Back to resultsPhysical Therapy for Temporomandibular Joint (TMJ) Closed Lock
Primary Purpose
Temporomandibular Joint Disorders, Temporomandibular Joint Disc Displacement, Without Reduction
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
physical therapy
control
Sponsored by
About this trial
This is an interventional treatment trial for Temporomandibular Joint Disorders focused on measuring temporomandibular joint, rehabilitation medicine, joint diseases, physical therapy
Eligibility Criteria
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.
Sites / Locations
- univ hospital sint Rafael, KULeuven
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
control
physical therapy
Arm Description
information, avoiding parafunctions
mobilisation, exercises ,..
Outcomes
Primary Outcome Measures
pain intensity
using VAS scales
Secondary Outcome Measures
mouth opening
interincisal dstance measured by a ruler upon active and passive mouth opening
pressure pain threshold
the pressure pain threshold was measured using an algometer at the masseter and temporalis muscles bilaterally
mandibular function impairment questionnaire
Using a validated questionnaire the impact of the pain and limitaiton on normal masticatory function is monitored
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01475630
Brief Title
Physical Therapy for Temporomandibular Joint (TMJ) Closed Lock
Official Title
Randomised Controlled Trial on Physical Therapy PT) for TMJ Closed Lock
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KU Leuven
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Disorders, Temporomandibular Joint Disc Displacement, Without Reduction
Keywords
temporomandibular joint, rehabilitation medicine, joint diseases, physical therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
Other
Arm Description
information, avoiding parafunctions
Arm Title
physical therapy
Arm Type
Experimental
Arm Description
mobilisation, exercises ,..
Intervention Type
Procedure
Intervention Name(s)
physical therapy
Other Intervention Name(s)
physiotherapy
Intervention Description
mobilisation of the jaw, exercises, boostering information on avoiding parafunctions
Intervention Type
Procedure
Intervention Name(s)
control
Other Intervention Name(s)
counseling, information
Intervention Description
relaxation
Primary Outcome Measure Information:
Title
pain intensity
Description
using VAS scales
Time Frame
1 year
Secondary Outcome Measure Information:
Title
mouth opening
Description
interincisal dstance measured by a ruler upon active and passive mouth opening
Time Frame
1 year
Title
pressure pain threshold
Description
the pressure pain threshold was measured using an algometer at the masseter and temporalis muscles bilaterally
Time Frame
1 year
Title
mandibular function impairment questionnaire
Description
Using a validated questionnaire the impact of the pain and limitaiton on normal masticatory function is monitored
Time Frame
1 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoon De Laat, DDS,PhD
Organizational Affiliation
Catholic University Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
univ hospital sint Rafael, KULeuven
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
12. IPD Sharing Statement
Citations:
PubMed Identifier
22318373
Citation
Craane B, Dijkstra PU, Stappaerts K, De Laat A. Randomized controlled trial on physical therapy for TMJ closed lock. J Dent Res. 2012 Apr;91(4):364-9. doi: 10.1177/0022034512438275. Epub 2012 Feb 8.
Results Reference
derived
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Physical Therapy for Temporomandibular Joint (TMJ) Closed Lock
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