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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Arizona
ClinicalTrials.gov Identifier:
NCT00856167
First received: March 3, 2009
Last updated: June 20, 2013
Last verified: January 2013
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: TCM for TMD: A Multi-Site Whole Systems Trial

Resource links provided by NLM:


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
Study Completion Date: December 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: TCM
Whole systems traditional Chinese medicine
Other: TCM
whole system Traditional Chinese Medicine, including acupuncture, herbs, tuina, lifestyle counseling
Active Comparator: Self-care
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

  Show Detailed Description

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
University of Arizona
Investigators
Principal Investigator: Cheryl Ritenbaugh, PhD, MPH U of Arizona
  More Information

Publications:
Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT00856167     History of Changes
Other Study ID Numbers: 06-0289-01, U01AT002570
Study First Received: March 3, 2009
Last Updated: June 20, 2013
Health Authority: United States: Food and Drug Administration
United States: Federal Government

Keywords provided by University of Arizona:
temporomandibular dysfunction
TMD
TMJ
Traditional Chinese Medicine
TCM

Additional relevant MeSH terms:
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Craniomandibular Disorders
Jaw Diseases
Joint Diseases
Mandibular Diseases
Muscular Diseases
Musculoskeletal Diseases
Myofascial Pain Syndromes
Stomatognathic Diseases

ClinicalTrials.gov processed this record on November 20, 2014