This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
University of Arizona Identifier:
First received: March 3, 2009
Last updated: May 26, 2015
Last verified: May 2015
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 Drug: TCM Behavioral: Self-care for TMD Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 ]

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

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, 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

  Show Detailed Description


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.
  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 identifier: NCT00856167

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

Responsible Party: University of Arizona Identifier: NCT00856167     History of Changes
Other Study ID Numbers: 06-0289-01
U01AT002570 ( U.S. NIH Grant/Contract )
Study First Received: March 3, 2009
Last Updated: May 26, 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 processed this record on August 21, 2017