NCT00856167

Brief Summary

This study sought 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, reported here) 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2006

Typical duration for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 5, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
14.9 years until next milestone

Results Posted

Study results publicly available

October 23, 2025

Completed
Last Updated

October 23, 2025

Status Verified

June 1, 2022

Enrollment Period

3.3 years

First QC Date

March 3, 2009

Results QC Date

June 2, 2022

Last Update Submit

October 8, 2025

Conditions

Temporomandibular Dysfunction

Keywords

temporomandibular dysfunctionTMDTMJTraditional Chinese MedicineTCM

Outcome Measures

Primary Outcomes (1)

  • Characteristic Facial Pain Score

    The Characteristic Facial Pain (CFP) score is a mean of participant-reported worst pain over the previous two weeks, average pain when having pain over the previous two weeks, and current pain, reported on a 0-10 VAS scale where 0 means no pain and 10 means worst possible pain.

    Beginning of each treatment period, end of each treatment period (8 weeks later)

Study Arms (2)

Traditional Chinese Medicine

ACTIVE COMPARATOR

Whole systems traditional Chinese medicine, including herbal formulas, acupuncture, tuna (Chinese massage), lifestyle recommendations

Combination Product: Traditional Chinese Medicine

Self-care

ACTIVE COMPARATOR

Self-care for TMD developed by Dworkin, LeResche et al.

Behavioral: Self-care for TMD

Interventions

Traditional Chinese MedicineCOMBINATION_PRODUCT

Whole systems traditional Chinese medicine, including individually tailored herbal formulas based on a formulary, acupuncture (based on individual TCM diagnoses), tuna (Chinese massage), lifestyle recommendations

Traditional Chinese Medicine
Self-care for TMDBEHAVIORAL

a 5-session 8 hour intervention targeting TMD knowledge, stretching and exercises, stress reduction, lifestyle modification

Self-care

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Ritenbaugh C, Hammerschlag R, Dworkin SF, Aickin MG, Mist SD, Elder CR, Harris RE. Comparative effectiveness of traditional Chinese medicine and psychosocial care in the treatment of temporomandibular disorders-associated chronic facial pain. J Pain. 2012 Nov;13(11):1075-89. doi: 10.1016/j.jpain.2012.08.002. Epub 2012 Oct 9.

    PMID: 23059454RESULT

  • Elder C, Ritenbaugh C, Aickin M, Hammerschlag R, Dworkin S, Mist S, Harris RE. Reductions in pain medication use associated with traditional Chinese medicine for chronic pain. Perm J. 2012 Summer;16(3):18-23. doi: 10.7812/TPP/12.967.

    PMID: 23012594RESULT

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Medicine, Chinese TraditionalSelf Care

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Medicine, East Asian TraditionalMedicine, TraditionalComplementary TherapiesTherapeuticsRehabilitationHealth ServicesHealth Care Facilities Workforce and Services

Results Point of Contact

Title
Dr. Cheryl Ritenbaugh, Principal Investigator
Organization
University of Arizona
ritenbau@email.arizona.edu
520-822-6710

Study Officials

  • Cheryl Ritenbaugh, PhD, MPH

    U of Arizona

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2009

First Posted

March 5, 2009

Study Start

October 1, 2006

Primary Completion

January 1, 2010

Study Completion

December 1, 2010

Last Updated

October 23, 2025

Results First Posted

October 23, 2025

Record last verified: 2022-06