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Completed

NCT Number: NCT01475630

Physical Therapy for Temporomandibular Joint (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.

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Key information

Conditions

Temporomandibular Joint Disorders Craniomandibular Disorders Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Stomatognathic Diseases Temporomandibular Joint Disc Displacement, Without Reduction

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

univ hospital sint Rafael, KULeuven

Leuven, B-3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

physical therapy

Procedure

mobilisation of the jaw, exercises, boostering information on avoiding parafunctions

Other names: physiotherapy

Control

Procedure

relaxation

Other names: counseling, information

Primary outcomes

  1. pain intensity

    Time frame: 1 year

    using VAS scales

Secondary outcomes

  1. mouth opening

    Time frame: 1 year

    interincisal dstance measured by a ruler upon active and passive mouth opening

  2. pressure pain threshold

    Time frame: 1 year

    the pressure pain threshold was measured using an algometer at the masseter and temporalis muscles bilaterally

  3. 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

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2011
Study completion
2011
First posted
Nov 21, 2011
Registry last updated
Nov 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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