NCT00769561

Biofeedback-Based Cognitive Behavioral Treatment for Temporomandibular Disorders

Comparison of a Biofeedback-Based Cognitive Behavioral Treatment and Occlusal Splint Therapy for Temporomandibular Disorders. A Randomized Clinical Trial.

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Philipps University Marburg · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Temporomandibular Disorders

Interventions

Type	Name	Description
BEHAVIORAL	Biofeedback-Based Cognitive Behavioral Treatment	The biofeedback-based cognitive behavioral intervention comprises 8 individual sessions, each containing both cognitive behavioral and biofeedback elements. Treatment elements are education about the disorder, biofeedback training aimed at improving proprioceptive awareness and reversing parafunctional habits, relaxation techniques, and stress management. Furthermore patients receive portable biofeedback devices for EMG-biofeedback training during day and nighttime in order to reverse diurnal and nocturnal bruxing habits.
DEVICE	Dental treatment with occlusal splint (OS)	Maxillary or mandibular occlusal splints are made of hard acrylic after taking impressions of the upper and lower dental arches, face bow registration and recording of centric relation. Splints are adjusted to provide even occlusal contact during jaw closing and chewing, and canine and incisor contact during protrusive movements of the jaw. Patients are instructed to use the splint each night and during day time for a period of 7 weeks. One week after initial insertion of the splint patients are requested to return for adjustment.

Timeline

• Start date: 2008-08-01
• Primary completion: 2010-07-01
• Completion: 2011-04-01
• First posted: 2008-10-09
• Last updated: 2013-12-30
• Results posted: 2013-12-30

Locations

2 sites across 1 country: Germany