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Sponsors and Collaborators: |
Philipps University Marburg Medical Center Psychotherapie-Ambulanz Marburg e.V. |
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Information provided by: | Philipps University Marburg Medical Center |
ClinicalTrials.gov Identifier: | NCT00769561 |
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.
Condition | Intervention | Phase |
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Temporomandibular Disorders |
Behavioral: Biofeedback-Based Cognitive Behavioral Treatment Device: Interocclusal splint therapy |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Parallel Assignment, Randomized, Safety/Efficacy Study, Single Blind (Outcomes Assessor), Treatment |
Official Title: | Comparison of a Biofeedback-Based Cognitive Behavioral Treatment and Occlusal Splint Therapy for Temporomandibular Disorders. A Randomized Clinical Trial. |
Estimated Enrollment: | 100 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Biofeedback-based cognitive behavioral treatment
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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.
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2: Active Comparator
Interocclusal splint therapy
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Device: Interocclusal splint therapy
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.
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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 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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Winfried Rief, Prof. Dr. | 0049-6421-2823657 | rief@staff.uni-marburg.de |
Contact: Meike C Juergens, Dipl. Psych. | 0049-6421-2824024 | m.juergens@staff.uni-marburg.de |
Germany | |
Department of Clinical Psychology and Psychotherapy, Philipps University Marburg | Recruiting |
Marburg, Germany, 35032 | |
Contact: Winfried Rief, Prof. Dr. 0049-6421-2823657 rief@staff.uni-marburg.de | |
Principal Investigator: Meike C Juergens, Dipl. Psych. | |
Department of Oral and Maxillofacial Surgery, Philipps University Marburg Medical Center | Recruiting |
Marburg, Germany, 35032 | |
Contact: Andreas Neff, Prof.Dr.Dr. 0049-6421-5863208 mkg@med.uni-marburg.de |
Study Chair: | Winfried Rief, Prof. Dr. | Department of Clinical Psychology and Psychotherapy, Philipps University Marburg, Germany |
Study Director: | Gaby M Bleichhardt, Dr. (PhD) | Department of Clinical Psychology and Psychotherapy, Philipps University Marburg, Germany |
Principal Investigator: | Meike C Juergens, Dipl. Psych. | Department of Clinical Psychology and Psychotherapy, Philipps University Marburg, Germany |
Responsible Party: | Department of Clinical Psychology and Psychotherapy ( Prof. Dr. Winfried Rief ) |
Study ID Numbers: | TMD_Jue2008 |
Study First Received: | October 8, 2008 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00769561 History of Changes |
Health Authority: | Germany: Ethics Commission |
Biofeedback Cognitive behavioral therapy Pain Temporomandibular disorders |
Temporomandibular Joint Disorders Muscular Diseases Musculoskeletal Diseases Temporomandibular Joint Dysfunction Syndrome Myofascial Pain Syndromes Fibromyalgia |
Craniomandibular Disorders Joint Diseases Salicylic Acid Pain Stomatognathic Diseases |
Mandibular Diseases Temporomandibular Joint Disorders Muscular Diseases Pathologic Processes Disease Musculoskeletal Diseases |
Temporomandibular Joint Dysfunction Syndrome Myofascial Pain Syndromes Joint Diseases Craniomandibular Disorders Jaw Diseases Stomatognathic Diseases |