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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
        

Pain

Typically, when investigating TMD as a symptom state, pain reduction is the primary symptom outcome by which the usefulness of a TMD treatment intervention will be evaluated. Hence, at the onset, cases selected for inclusion in such an RCT should enter the study with pain, preferably pain further operationalized with regard to duration (e.g. pain of at least three months duration) and intensity (e.g. pain levels of 3 or greater on a 10-point scale).

However, because TMD pain is known to fluctuate, evaluating the patient for the presence of pain may not be so straightforward. For example, asking the potential study case: "do you have pain in the muscles of your face, or your jaw joint" may result in a "no" answer because, at the moment the patient has no pain although orofacial pain is a characteristic feature of their everyday life.

Thus, the question about pain should include additional precise operational terms, such as: …" in the past month, do you have …pain most of the time…", or "… in the past 2 weeks, about how many hours of the day have you had pain…". TMD patients frequently report no pain "right now" when queried by their dentist even though they consider themselves burdened with TMD pain problem a great deal of the time.



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