Temporomandibular Disorders Clinical Trial
Official title:
Comparison of a Biofeedback-Based Cognitive Behavioral Treatment and Occlusal Splint Therapy for Temporomandibular Disorders. A Randomized Clinical Trial.
The purpose of this study is to develop and evaluate a biofeedback-based cognitive behavioral treatment for patients with chronic temporomandibular disorders using a randomized controlled design.
The purpose of this study is to develop and evaluate a biofeedback-based cognitive
behavioral treatment for temporomandibular disorders using a randomized controlled design.
100 patients suffering from chronic temporomandibular disorder are diagnosed using Research
Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD). Subsequently, patients are
randomly assigned to either a psychological intervention receiving 8 sessions of
biofeedback-based cognitive behavioral treatment or to a dental intervention receiving
interocclusal splint therapy.
Assessment takes place at baseline, after treatment approximately 8 weeks later, 3 and 6
months follow up. The effects of the interventions are evaluated in terms of reduction in
pain intensity, pain related disability, psychological variables such as somatoform
symptoms, depression and pain related cognitive adjustment as well as nocturnal
electromyographic (EMG) activity.
Additionally, the study aims at identifying variables that predict treatment outcome.
Further analyses include initial changes in treatment motivation and illness perceptions and
its influence on treatment success, as well as changes in psychophysiological stress
reactivity through treatment.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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