Effects of Masseter Manual Therapy on Temporomandibular Dysfunction

Temporomandibular Joint Dysfunction Syndrome Clinical Trial

Official title:

Effects of Masseter Manual Therapy on Temporomandibular Dysfunction: A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00870922
• Other study ID #: SR0204090171
• Secondary ID: 388
• Status: Recruiting
• Phase: Phase 1
• First received: March 25, 2009
• Last updated: March 25, 2009
• Start date: March 2009
• Est. completion date: May 2009

Study information

• Verified date: March 2009
• Source: Logan College of Chiropractic
• Contact: James George, DC
• Phone: 636-230-1938
• Email: james.george[@]logan.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Joint Diseases
• Temporomandibular Joint
• Temporomandibular Joint Disorder
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Procedure:
• Active release techniques
Participants will receive ART and have Therabite (mouth opening) and pain (VAS) measured before and after ART

Locations

Country	Name	City	State
United States	Logan University, College of Chiropractic	Chesterfield	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Logan College of Chiropractic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Range of Motion		2 weeks	No
Secondary	VAS pain scale		2 Weeks	No