Traditional Chinese Medicine (TCM) for Temporomandibular Dysfunction (TMD): A Whole Systems Multi-site Trial (TCM-TMD)
This study has been completed.
Sponsor:
University of Arizona
Collaborator:
Information provided by (Responsible Party):
University of Arizona
ClinicalTrials.gov Identifier:
NCT00856167
First received: March 3, 2009
Last updated: January 16, 2013
Last verified: January 2013
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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 More Information
No publications provided by University of Arizona
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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: | January 16, 2013 |
| Health Authority: | United States: Food and Drug Administration United States: National Center for Complementary and Alternative Medicine |
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 Mandibular Diseases Jaw Diseases |
Musculoskeletal Diseases Joint Diseases Muscular Diseases Stomatognathic Diseases Myofascial Pain Syndromes |
ClinicalTrials.gov processed this record on May 19, 2013