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Effects of Masseter Manual Therapy on Temporomandibular Dysfunction

Primary Purpose

Temporomandibular Joint, Temporomandibular Joint Dysfunction Syndrome, Temporomandibular Joint Disorder

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Active release techniques
Sponsored by
Logan College of Chiropractic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Joint

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Logan University, College of ChiropracticRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TMD group

Arm Description

Participants will receive ART and have Therabite (mouth opening) and pain (VAS) measured before and after ART

Outcomes

Primary Outcome Measures

Range of Motion

Secondary Outcome Measures

VAS pain scale

Full Information

First Posted
March 25, 2009
Last Updated
March 25, 2009
Sponsor
Logan College of Chiropractic
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1. Study Identification

Unique Protocol Identification Number
NCT00870922
Brief Title
Effects of Masseter Manual Therapy on Temporomandibular Dysfunction
Official Title
Effects of Masseter Manual Therapy on Temporomandibular Dysfunction: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Unknown status
Study Start Date
March 2009 (undefined)
Primary Completion Date
May 2009 (Anticipated)
Study Completion Date
May 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Logan College of Chiropractic

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint, Temporomandibular Joint Dysfunction Syndrome, Temporomandibular Joint Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TMD group
Arm Type
Experimental
Arm Description
Participants will receive ART and have Therabite (mouth opening) and pain (VAS) measured before and after ART
Intervention Type
Procedure
Intervention Name(s)
Active release techniques
Intervention Description
Participants will receive ART and have Therabite (mouth opening) and pain (VAS) measured before and after ART
Primary Outcome Measure Information:
Title
Range of Motion
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
VAS pain scale
Time Frame
2 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
James George, DC
Phone
636-230-1938
Ext
1938
Email
james.george@logan.edu
Facility Information:
Facility Name
Logan University, College of Chiropractic
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

Effects of Masseter Manual Therapy on Temporomandibular Dysfunction

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