Physical Therapy for Temporomandibular Joint (TMJ) Closed Lock

Temporomandibular Joint Disorders Clinical Trial

Official title:

Randomised Controlled Trial on Physical Therapy PT) for TMJ Closed Lock

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01475630
• Other study ID #: ML2210
• Status: Completed
• Phase: N/A
• First received: November 17, 2011
• Last updated: November 21, 2011
• Start date: June 2003
• Est. completion date: November 2011

Study information

• Verified date: November 2011
• Source: Katholieke Universiteit Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: November 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Joint Diseases
• Temporomandibular Joint Disc Displacement, Without Reduction
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Procedure:
• physical therapy
mobilisation of the jaw, exercises, boostering information on avoiding parafunctions
• control
relaxation

Locations

Country	Name	City	State
Belgium	univ hospital sint Rafael, KULeuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Katholieke Universiteit Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain intensity	using VAS scales	1 year	No
Secondary	mouth opening	interincisal dstance measured by a ruler upon active and passive mouth opening	1 year	No
Secondary	pressure pain threshold	the pressure pain threshold was measured using an algometer at the masseter and temporalis muscles bilaterally	1 year	No
Secondary	mandibular function impairment questionnaire	Using a validated questionnaire the impact of the pain and limitaiton on normal masticatory function is monitored	1 year	No