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

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ClinicalTrials.gov Identifier: NCT00856167
Recruitment Status : Completed
First Posted : March 5, 2009
Last Update Posted : May 27, 2015
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
University of Arizona

Brief Summary:
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 or disease Intervention/treatment Phase
Temporomandibular Dysfunction Drug: TCM Behavioral: Self-care for TMD Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: TCM for TMD: A Multi-Site Whole Systems Trial
Study Start Date : September 2006
Primary Completion Date : January 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: TCM
Whole systems traditional Chinese medicine, including individually tailored herbal formulas, acupuncture, tuna (Chinese massage), lifestyle recommendations
Drug: 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

Primary Outcome Measures :
  1. Worst facial pain [ Time Frame: Previous 2 weeks ]

Secondary Outcome Measures :
  1. Interference with social activities [ Time Frame: Previous 2 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00856167

Sponsors and Collaborators
University of Arizona
National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: Cheryl Ritenbaugh, PhD, MPH U of Arizona

Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT00856167     History of Changes
Other Study ID Numbers: 06-0289-01
U01AT002570 ( U.S. NIH Grant/Contract )
First Posted: March 5, 2009    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: May 2015

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

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