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

NCT ID: NCT00856167

Last Updated: 2025-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2010-12-31

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.

Detailed Description

Studies of temporomandibular disorders (TMD) have shown that chronic pain in the temporomandibular joint (TMJ) and/or masticatory muscles affects more than 10% of adults at any one time and that one-third of adults will experience TMD over their lifespan (Von Korff et al. 1988). TMD includes a wide range of symptoms: facial pain, jaw-joint pain, headaches, earaches, dizziness, masticatory musculature hypertrophy, limited mouth opening, closed or open lock on the TMJ, abnormal occlusal wear, clicking or popping sounds in the jaw joint, and other complaints (NIH 1996). Although the etiology is poorly understood, longitudinal data suggest that TMD is an enduring, recurrent condition and a resistant problem for many (Dworkin et al. 1992a; Dworkin et al. 1989; Moss 1982; Gale 1978), and it affects individuals in all socioeconomic and ethnic groups (Smith & Syrop 1994). In a study of TMD patients in Kaiser Permanente Northwest (KPNW) in 1990-1995, the mean age was 40.5 years, and 80% of the patients were female. TMD subjects used 1.6 times the services of other health plan members (White 2001).

The Research Diagnostic Criteria for TMD (RDC/TMD) proposed by Dworkin et al. (Dworkin & LeResche 1992b) uses a dual axis system for diagnosing and classifying TMD patients. Axis I assigns physical diagnoses of the most commonly occurring masticatory muscle and/or TMJ disorders (arthralgia, arthritis, and arthroses of the TMJ). Axis II assesses behavioral, psychological and psychosocial factors; functional mandibular limitations; psychological distress, including depression; and Graded Scale of Chronic Pain (GCP) (Von Korff et al. 1992). The RDC/TMD criteria for Axes I and II have been used in numerous clinical research studies around the world (Ohrbach & Dworkin 1998; List et al. 1996; Rudy et al. 1995; Garofalo & Wesley 1998; Yap et al. 2002). An NIH-supported international consortium of RDC/TMD clinical researchers has been established to foster multinational studies of TMD using as their core the RDC/TMD standardized methods and criteria (http://www.rdc-tmdinternational.org/). The RDC/TMD has been suggested as a model system for the diagnosis and assessment of all chronic pain conditions (Garofolo & Wesley 1997; Dworkin, Sherman et al. 2002). The RDC/TMD is being used in this study for the primary endpoint.

Epidemiological studies of TMD have focused on estimating prevalence and describing characteristics of persons with and without the condition (Carlsson & LeResche 1995). In more than 75% of the studies reviewed, TMD was not adequately defined. Epidemiologic and clinical studies of TMD confirm its fundamental status as a chronic pain problem (Bell 1986; Fricton et al. 1987; Dworkin et al. 1992a). Yap et al. (2003) found that about 39% of TMD patients also are depressed, and 55% exhibit elevated levels of somatization. Similarly, Lee et al. (1995) found that TMD patients frequently present ear pain, neck pain, shoulder pain, headaches, and previous head or neck trauma.

Despite a number of temporomandibular joint pain clinical trials, no approach has been found to persistently and significantly reduce the severity and disability of this condition. The investigators' recent phase II RCT (n=110 women) showed that Traditional Chinese Medicine (TCM), including acupuncture and herbs, was comparable to or better than comprehensive specialty usual care in reducing pain, and better in improving disability. The improvements did not persist, however, once TCM treatment ended. The investigators hypothesize that this may have been due in part to their lack of education in self-care management. Thus, when their pain returned, they knew of no other option than returning to their TCM practitioner which was not permitted under the protocol. This suggests that the appropriate way to incorporate TCM into TMD care should include a self-care component for all participants. This proposal tests TCM versus self- care management (SC) in a realistic manner that is consistent with an integrative, stepped care strategy, one that begins with a minimal self-care intervention (one session) and increases the intensity in relation to patient needs. After period 1 allocation to TCM or self-care, participants not already on TCM will be allocated to self-care or TCM if period 2 if continued treatment is warranted. This study design is more clinically meaningful than a customary two-group randomization, which does not consider patient outcomes (see study Schema below).

The investigators propose a two-site (Tucson and Portland) phase II trial (n=150) that will evaluate the potential short-term pain benefits of TCM. The study hypothesis is that in the two-step clinical allocation model, TCM participants will experience more characteristic facial pain reduction than those who receive only self-care. The investigators will expand the patient population beyond their previous study to include both men and women, as well as individuals who have received previous TMD care (not TCM) and continue to experience TMD pain.

Conditions

Temporomandibular Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Traditional Chinese Medicine

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

Group Type: ACTIVE_COMPARATOR

Traditional Chinese Medicine

Intervention Type: COMBINATION_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

Self-care

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

Group Type: ACTIVE_COMPARATOR

Self-care for TMD

Intervention Type: BEHAVIORAL

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

Interventions

Traditional Chinese Medicine

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

Intervention Type: COMBINATION_PRODUCT

Self-care for TMD

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

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

University of Arizona

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cheryl Ritenbaugh, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

U of Arizona

References

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.

Reference Type: RESULT

PMID: 23059454 (View on PubMed)

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.

Reference Type: RESULT

PMID: 23012594 (View on PubMed)

Other Identifiers

U01AT002570

Identifier Type: NIH

Identifier Source: secondary_id

View Link

06-0289-01

Identifier Type: -

Identifier Source: org_study_id