NCT00870922

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2009

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 27, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

March 27, 2009

Status Verified

March 1, 2009

Enrollment Period

2 months

First QC Date

March 25, 2009

Last Update Submit

March 25, 2009

Conditions

Temporomandibular JointTemporomandibular Joint Dysfunction SyndromeTemporomandibular Joint Disorder

Outcome Measures

Primary Outcomes (1)

  • Range of Motion

    2 weeks

Secondary Outcomes (1)

  • VAS pain scale

    2 Weeks

Study Arms (1)

TMD group

EXPERIMENTAL

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

Procedure: Active release techniques

Interventions

Active release techniquesPROCEDURE

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

TMD group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Logan University, College of Chiropractic

Chesterfield, Missouri, 63017, United States

RECRUITING

MeSH Terms

Conditions

Temporomandibular Joint Dysfunction SyndromeTemporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesMyofascial Pain SyndromesStomatognathic Diseases

Central Study Contacts

James George, DC

CONTACT

636-230-1938james.george@logan.edu

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 25, 2009

First Posted

March 27, 2009

Study Start

March 1, 2009

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

March 27, 2009

Record last verified: 2009-03

Locations

US(1)