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Biofeedback-Based Cognitive Behavioral Treatment for Temporomandibular Disorders
This study is currently recruiting participants.
Study NCT00769561   Information provided by Philipps University Marburg Medical Center
First Received: October 8, 2008   Last Updated: October 9, 2008   History of Changes

October 8, 2008
October 9, 2008
June 2008
July 2010   (final data collection date for primary outcome measure)
Pain intensity (German Pain Questionnaire; Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD)) [ Time Frame: Pre-Post-Design including 4 assessment points: pre-treatment, post-treatment, 3- and 6-month follow up ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00769561 on ClinicalTrials.gov Archive Site
  • Pain disability (Pain Disability Index; Jaw Disability List (RDC/TMD)) [ Time Frame: Pre-Post-Design including 4 assessment points: pre-treatment, post-treatment, 3- and 6-month follow up ] [ Designated as safety issue: No ]
  • Somatoform symptoms (Screening for Somatoform Disorders) [ Time Frame: Pre-Post-Design including 4 assessment points: pre-treatment, post-treatment, 3- and 6-month follow up ] [ Designated as safety issue: Yes ]
  • Psychopathology / Affect (Centers for Epidemiologic Studies Depression Scale) [ Time Frame: Pre-Post-Design including 4 assessment points: pre-treatment, post-treatment, 3- and 6-month follow up ] [ Designated as safety issue: No ]
  • Cognitive variables (Illness Perception Questionnaire; Questionnaire for Assessment of Level of Coping with Pain) [ Time Frame: Pre-Post-Design including 4 assessment points: pre-treatment, post-treatment, 3- and 6-month follow up ] [ Designated as safety issue: No ]
  • Nocturnal EMG masseter activity [ Time Frame: Pre-Post assessment ] [ Designated as safety issue: No ]
Same as current
 
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.

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 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.

Phase II, Phase III
Interventional
Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Temporomandibular Disorders
  • Behavioral: Biofeedback-Based Cognitive Behavioral Treatment
  • Device: Interocclusal splint therapy
  • Experimental: Biofeedback-based cognitive behavioral treatment
  • Active Comparator: Interocclusal splint therapy
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
100
July 2010
July 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • clinical diagnosis of painful temporomandibular disorder according to Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD)
  • symptoms persist at least 3 months
  • sufficient language skills

Exclusion Criteria:

  • somatic diagnosis that requires defined somatic treatment (e.g. occlusal interference)
  • presence of a psychotic disorder
  • presence of neurological disorders (e.g. dementia)
  • alcohol or substance abuse
  • presence of other pain condition of predominant severity
Both
18 Years to 70 Years
No
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
 
NCT00769561
Prof. Dr. Winfried Rief, Department of Clinical Psychology and Psychotherapy
TMD_Jue2008
Philipps University Marburg Medical Center
Psychotherapie-Ambulanz Marburg e.V.
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
Philipps University Marburg Medical Center
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP