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Clinical Trials in TMD Sections
Author Bio
Introduction
The Biopsychosocial Model
Designing Multicenter RCTs
Players in an RCT
Currently selected section: 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
Implementing RCTs: Practical Issues
Analysis of TMD Trials
Conclusions
Acknowledgments
Appendix A
Appendix B

 

Chapter 22: Clinical Trials in Temporomandibular: Randomization
          

Inclusion and Exclusion Criteria

Eligibility criteria for participation in an RCT include inclusion and exclusion criteria that are determined a priori, according to specific study needs. The inclusion and exclusion criteria designed for a particular RCT determine who is eligible to be randomized to experimental and control groups.

Figure 5.1 schematically depicts the sequential steps and flow of patients through an RCT. The example provided relates to two RCTs depicted here which maximizes use of TMD clinic patients and involves biobehavioral interventions discussed at several points in this chapter (Dworkin et al, 2002).

Figure 5.1 Patient Flow into Two RCTs Being Conducted in Parallel
Graphic depiction of patient flow into two RCTs. Initial visit includes RDC Axis I / Axis II Examination, History, Diagnosis and Treatment. 1. Determine study eligibility, 2. Recruit, 3. enroll in separate RCTs. Either: Axis II Chronic Pain Grade I or II = low, n=124; or Axis II Chronic Pain Grade II – High, or III, IV, n=118. From either RCT, randomization immediately prior to first study clinic visit. For Grade I or II, randomize to either Self Management (RDH, 3 sessions, 2 phone calls No usual treatment.) or Usual DDS care. For Grade High, randomize to Usual DDS care or Comprehensive Care (clinical psychologist, 6 sessions, 3 phone calls plus usual DDS care). Follow up for either RCT includes Post treatment, 6 and 12 months.

 

Important considerations include age, gender, level of education, mental and linguistic competence.

Exclusion criteria might include patients without pain, currently under active treatment for another pain condition, or taking relevant pain or muscle relaxant medications, etc.

There can be no hard and fast specific inclusion and exclusion criteria because who is allowed to participate in any particular RCT is determined to an important extent by the specific aims of particular RCTs.

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