Traditional Chinese Medicine (TCM) for Temporomandibular Dysfunction (TMD): A Whole Systems Multi-Site Trial - Full Text View

Traditional Chinese Medicine (TCM) for Temporomandibular Dysfunction (TMD): A Whole Systems Multi-Site Trial (TCM-TMD)

This study is ongoing, but not recruiting participants.

First Received: March 3, 2009 Last Updated: March 4, 2009 History of Changes

Sponsors and Collaborators:	University of Arizona National Institutes of Health (NIH)
Information provided by:	University of Arizona
ClinicalTrials.gov Identifier:	NCT00856167

Purpose

This study seeks to evaluate the benefits of different combinations of a Self Care program, involving individually targeted education and support, plus Traditional Chinese Medicine, in terms of patients' experience and outcomes in short-term follow-up (8 weeks) and long-term follow-up (18-months). The study seeks to evaluate the benefits and drawbacks of different patterns of stepped care, which means different levels of care depending on patients' responses at various time-points in the study, which might be used by clinicians treating in the future.

Condition	Intervention	Phase
Temporomandibular Dysfunction	Other: TCM Behavioral: Self-care for TMD	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	TCM for TMD: A Multi-Site Whole Systems Trial

Resource links provided by NLM:

MedlinePlus related topics: Temporomandibular Joint Dysfunction

U.S. FDA Resources

Further study details as provided by University of Arizona:

Primary Outcome Measures:

Worst facial pain [ Time Frame: Previous 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Interference with social activities [ Time Frame: Previous 2 weeks ] [ Designated as safety issue: No ]

Enrollment:	160
Study Start Date:	September 2006
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
TCM: Active Comparator Whole systems traditional Chinese medicine	Other: TCM whole system Traditional Chinese Medicine, including acupuncture, herbs, tuina, lifestyle counseling
Self-care: Active Comparator Self-care for TMD developed by Dworkin, LeResche et al.	Behavioral: Self-care for TMD a 5-session 8 hour intervention targeting TMD knowledge, stretching and exercises, stress reduction, lifestyle modification

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Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

TMD as diagnosed according to the Research Diagnostic Criteria-TMD by a trained dentist;
worst facial pain greater than 5 out of 10.

Exclusion Criteria:

prior surgery for TMD;
life-threatening illnesses;
conditions that would prevent participation in trial including consumption of Chinese herbs.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00856167

Sponsors and Collaborators

University of Arizona

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Cheryl Ritenbaugh, PhD, MPH

U of Arizona

More Information

No publications provided

Responsible Party:	University of Arizona ( Cheryl Ritenbaugh, Principal Investigator )
Study ID Numbers:	06-0289-01, 5 U01 AT002570-02
Study First Received:	March 3, 2009
Last Updated:	March 4, 2009
ClinicalTrials.gov Identifier:	NCT00856167 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Arizona:

temporomandibular dysfunction
TMD
TMJ
Traditional Chinese Medicine
TCM

Study placed in the following topic categories:

Temporomandibular Joint Disorders
Muscular Diseases
Musculoskeletal Diseases
Temporomandibular Joint Dysfunction Syndrome
Myofascial Pain Syndromes

Fibromyalgia
Craniomandibular Disorders
Joint Diseases
Pain
Stomatognathic Diseases

Additional relevant MeSH terms:

Mandibular Diseases
Temporomandibular Joint Disorders
Muscular Diseases
Musculoskeletal Diseases
Temporomandibular Joint Dysfunction Syndrome

Myofascial Pain Syndromes
Joint Diseases
Craniomandibular Disorders
Jaw Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on September 10, 2009