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Physical Therapy for Temporomandibular Joint (TMJ) Closed Lock

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
prof.dr. Antoon De Laat, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:
NCT01475630
First received: November 17, 2011
Last updated: November 21, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition Intervention
Temporomandibular Joint Disorders
Temporomandibular Joint Disc Displacement, Without Reduction
 Procedure: physical therapy
Procedure: control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomised Controlled Trial on Physical Therapy PT) for TMJ Closed Lock

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • pain intensity [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    using VAS scales


Secondary Outcome Measures:
  • mouth opening [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    interincisal dstance measured by a ruler upon active and passive mouth opening

  • pressure pain threshold [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    the pressure pain threshold was measured using an algometer at the masseter and temporalis muscles bilaterally

  • mandibular function impairment questionnaire [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Using a validated questionnaire the impact of the pain and limitaiton on normal masticatory function is monitored


Enrollment: 49
Study Start Date: June 2003
Study Completion Date: November 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
control
information, avoiding parafunctions
 Procedure: control
relaxation
Other Names:
  • counseling
  • information
Experimental: physical therapy
mobilisation, exercises ,..
 Procedure: physical therapy
mobilisation of the jaw, exercises, boostering information on avoiding parafunctions
Other Name: physiotherapy

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01475630

Locations
Belgium
univ hospital sint Rafael, KULeuven
Leuven, Belgium, B-3000
Sponsors and Collaborators
Katholieke Universiteit Leuven
Investigators
Principal Investigator: Antoon De Laat, DDS,PhD Catholic University Leuven
  More Information

No publications provided

Responsible Party: prof.dr. Antoon De Laat, Head of Service Dentistry, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier: NCT01475630     History of Changes
Other Study ID Numbers: ML2210
Study First Received: November 17, 2011
Last Updated: November 21, 2011
Health Authority: Belgium: Ethics Committee

Keywords provided by Katholieke Universiteit Leuven:
temporomandibular joint
rehabilitation medicine
joint diseases
physical therapy

Additional relevant MeSH terms:
Joint Diseases
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Musculoskeletal Diseases
Craniomandibular Disorders
 Mandibular Diseases
Jaw Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes

ClinicalTrials.gov processed this record on May 21, 2013