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Clinical Trials in TMD Sections
Author Bio
Introduction
The Biopsychosocial Model
Designing Multicenter RCTs
Players in an RCT
Randomization
Trial Design Quality
Currently selected section: TMD Case Definition
Endpoints and Outcome Measures
Blinding & Masking
Study Sample Size
Number and Nature of Interventions
Study Length and Follow up
Intent-to-treat Analyses and Sample Size
Compliance
Multicenter RCTs
Implementing RCTs: Practical Issues
Analysis of TMD Trials
Conclusions
Acknowledgments
Appendix A
Appendix B

 

Chapter 22: Clinical Trials in Temporomandibular: TMD Case Definition
        

Clinical Diagnosis

Often clinical cases for inclusion in an RCT are defined according to validated diagnostic categories (e.g. Diabetes, Type I; Endometrial Cancer, Stage II; Gingivitis).

Historically, an important obstacle to case definition by clinical diagnosis of TMD (e.g. Myofascial pain; Ostearthritis of the TMJ) has been the absence of any reliable and valid scheme for diagnosing TMD patients according to operational criteria, although even modest lack of agreement in diagnostic criteria can lead to serious misclassification of TMD cases (LeResche et al., 1991).

A carefully developed and acknowledged clinically useful diagnostic scheme for TMD, the Guidelines for Classification, Assessment and Management of TMD (The American Academy of Craniomandibular Disorders, 1990), still lacks suitable operational criteria to allow adequate evaluation of its reliability and validity or to allow its use in rigorous RCTs investigating TMD.

In an attempt to address these shortcomings, research diagnostic criteria for temporomandibular disorders (RDC/TMD) have been developed and made available to researchers and clinicians for scientific evaluation (Dworkin and LeResche, 1992). The RDC/TMD was developed by a team of international clinical research experts gathered together (with NIDCR support) to develop, to the largest extent possible, an empirically-based and operationalized system for diagnosing and classifying RDC/TMD, based on the best available scientific data, within the context of a biopsychosocial model.

The RDC/TMD uses a dual axis system that allows:

  • On Axis I - a physical diagnosis based on pathophysiology; coordinated with
  • On Axis II - an assessment of TMD-pain and related parafunctional behaviors, psychological distress and psychosocial dysfunction

The RDC/TMD uses clinical examination and history-gathering methods with scientifically demonstrated reliability for gathering clinical signs of TMD, and which also include assessment of behavioral, psychological and psychosocial factors. The complete RDC/TMD publication is available at a web-site created by a consortium of world-wide researchers using the RDC/TMD http://rdc-tmdinternational.org, which includes:

  • The complete RDC/TMD Axis I examination;
  • The Axis II questionnaire;
  • Detailed specifications for conducting an RDC/TMD clinical examination;
  • Operationally defined criteria for an Axis I diagnosis of the most common forms of TMD;
  • Empirically-derived normative values for classifying patients on Axis II parameters of depression, somatization and grade of chronic pain; and
  • The rationale and background for developing the RDC/TMD.

Two recent RCTs used RDC/TMD Axis II criteria for graded chronic pain as the critical component of the TMD case definition (see Figure 5.1. for a schematic design of the RCTs) (Dworkin et al., 2002h; Dworkin et al., 2002b).


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