NCT01475630

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 21, 2011

Completed
Last Updated

November 22, 2011

Status Verified

November 1, 2011

Enrollment Period

8 years

First QC Date

November 17, 2011

Last Update Submit

November 21, 2011

Conditions

Temporomandibular Joint DisordersTemporomandibular Joint Disc Displacement, Without Reduction

Keywords

temporomandibular jointrehabilitation medicinejoint diseasesphysical therapy

Outcome Measures

Primary Outcomes (1)

  • pain intensity

    using VAS scales

    1 year

Secondary Outcomes (3)

  • mouth opening

    1 year

  • pressure pain threshold

    1 year

  • mandibular function impairment questionnaire

    1 year

Study Arms (2)

control

OTHER

information, avoiding parafunctions

Procedure: control

physical therapy

EXPERIMENTAL

mobilisation, exercises ,..

Procedure: physical therapy

Interventions

physical therapyPROCEDURE

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

Also known as: physiotherapy
physical therapy
controlPROCEDURE

relaxation

Also known as: counseling, information
control

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

univ hospital sint Rafael, KULeuven

Leuven, B-3000, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 22318373DERIVED

MeSH Terms

Conditions

Temporomandibular Joint DisordersJoint Diseases

Interventions

Physical Therapy ModalitiesCounseling

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesMuscular DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitationMental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Antoon De Laat, DDS,PhD

    Catholic University Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Service Dentistry

Study Record Dates

First Submitted

November 17, 2011

First Posted

November 21, 2011

Study Start

June 1, 2003

Primary Completion

June 1, 2011

Study Completion

November 1, 2011

Last Updated

November 22, 2011

Record last verified: 2011-11

Locations

BE(1)