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Effects of Masseter Manual Therapy on Temporomandibular Dysfunction

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Logan College of Chiropractic.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Logan College of Chiropractic
ClinicalTrials.gov Identifier:
NCT00870922
First received: March 25, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

Muscles and myofascial dysfunction are more often the mechanism and source of pain in oral fascial disorders (OFD) than the TMJ. Masticatory muscles in patients with TMJ alterations are more hypertonic, less efficient and more prone to fatigue compared to age and sex matched controls. It is our opinion that Active Release Technique can be a reliable assessment and treatment tool in the resolution in cervical-cranio mandibular disorders. Our goal is to improve masticatory function through treatment of trigger points in the masseter.


Condition Intervention Phase
Temporomandibular Joint
Temporomandibular Joint Dysfunction Syndrome
Temporomandibular Joint Disorder
 Procedure: Active release techniques
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Masseter Manual Therapy on Temporomandibular Dysfunction: A Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Logan College of Chiropractic:

Primary Outcome Measures:
  • Range of Motion [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • VAS pain scale [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: March 2009
Estimated Study Completion Date: May 2009
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TMD group
Participants will receive ART and have Therabite (mouth opening) and pain (VAS) measured before and after ART
 Procedure: Active release techniques
Participants will receive ART and have Therabite (mouth opening) and pain (VAS) measured before and after ART

Detailed Description:

Recruit 45 patients with TMD determined by questionnaire. Measure pre and post mandibular active range of motion and VAS pain scale. Treatment will include 4 visits over a two week span measuring before first treatment and after last treatment. There will be 3 treatment groups; active release technique, post isometric relaxation and a no treatment control group. We will analyze data for any change in mandibular range of motion and VAS pain scale.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Difficulty and/or pain when opening mouth
  • Jaw locking
  • Difficulty or pain when chewing or talking
  • TMJ clicking
  • Jaw stiffness, tightness, or fatigue
  • Pain in ear, temple or cheeks
  • Frequent headaches, neckaches, toothaches
  • Change in occlusion

Exclusion Criteria:

  • Trauma to head, neck or jaw within last 12 months
  • Recent dental extractions
  • Taking prescription analgesics/muscle relaxants
  • Recent cervical SMT (HVLA)
  • Already under care for condition
  • Sinus infection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00870922

Contacts
Contact: James George, DC 636-230-1938 ext 1938 james.george@logan.edu

Locations
United States, Missouri
Logan University, College of Chiropractic Recruiting
Chesterfield, Missouri, United States, 63017
Sponsors and Collaborators
Logan College of Chiropractic
  More Information

No publications provided

Responsible Party: Dr. James George, Jr, DC, Logan University, College of Chiropractic
ClinicalTrials.gov Identifier: NCT00870922     History of Changes
Other Study ID Numbers: SR0204090171, 388
Study First Received: March 25, 2009
Last Updated: March 25, 2009
Health Authority: United States: Institutional Review Board

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 16, 2013