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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
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
Currently selected section: Implementing RCTs: Practical Issues
Analysis of TMD Trials
Conclusions
Acknowledgments
Appendix A
Appendix B

 

Chapter 22: Clinical Trials in Temporomandibular: Multicenter RCTs
          

Measures

Pragmatic issues surround measures and measurement discussed below include, first, what will be measured, such as baseline and outcome TMD measures, and second, the reliability of self report and clinical measurement.

What can be measured: Baseline and Outcome Measures in TMD
Gleaned from several RCTs evaluating different aspects of TMD treatment, Table 16.3 can serve as a useful guide in the planning of RCTs.

Table 16.3 Domains of Measurement for Use in TMD Controlled Trials
Domain of Measurement Measurements
1. DemographicAge, gender, ethnicity, education, income

2. Physicial

  • Vertical and lateral mandibular range of motion
  • Muscle palpation pain
    •
  • Presence of TMJ clicking or crepitus
  • Jaw function tests
  • Occlusion classification and function
    		• Clinical findings resulting from a standardized clinical TMD examination (e.g. RDC/TMD) or from clinical examination methods and tests that are reproducible, operationally defined, and have reported values for reliability and validity

    3. Pharmacologic

  • NSAIDS
  • Narcotic analgesics
  • Anti-depressants
  • Anxiolytics
  • Muscle relaxants
  • Anti-epileptics/convulsants
    		• Self-reported or prescription tracking for amount and type of medication consumed; Clinical laboratory findings for measures of circulating drug levels and/or pharmacodynamics

    4. Behavioral

  • Sleep bruxism
  • Diurnal jaw clenching or bruxism
  • Other parafunctional jaw behaviors
    		• Self-report or observational measures of extent of jaw parafunctional behaviors

    5. Psychological

  • Depression
  • Anxiety
  • Somatization
  • Other psychological states and traits
    		• Reliable and valid self-report scales yielding scores reflecting psychological or emotional status

    6. Psychosocial

  • Interference with activities of daily living, (ability to perform usual responsibilities at work, home, school)
  • Extent of treatment-seeking and reliance on medications
  • Substance abuse
  • Anger
    		• Reliable and valid self-report scales yielding scores on level of psychosocial function and/or observational measures of work attendence; E.R. visits; Prescription refills and health care visits

    In this table, we see domains of measurement, including:

    • Demographic measurement
    • Physical measurement
    • Pharmacologic measurement
    • Behavioral measurement
    • Psychological measurement
    • Psychosocial measurement

    A useful recent addition to measures appropriate for incorporation into TMD trials relates to assessment of quality of life (Dworkin, 2001; Kowalski and Stohler, 2002).

    Again, within the guidelines and suggestions discussed later in this section on use and timing of measures, the final decisions about which of the measures reflect independent, dependent, or mediating variables and which of these are worthy of repeated measurement depends on the design and hypotheses of each specific RCT.


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