Biofeedback-Based Cognitive Behavioral Treatment for Temporomandibular Disorders

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Philipps University Marburg Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Psychotherapie-Ambulanz Marburg e.V.
Information provided by:
Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier:
NCT00769561
First received: October 8, 2008
Last updated: October 9, 2008
Last verified: October 2008

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
Not Provided
Not Provided
 
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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Temporomandibular Disorders
  • 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: 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.
  • Experimental: 1
    Biofeedback-based cognitive behavioral treatment
    Intervention: Behavioral: Biofeedback-Based Cognitive Behavioral Treatment
  • Active Comparator: 2
    Interocclusal splint therapy
    Intervention: Device: Interocclusal splint therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) 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
TMD_Jue2008
Yes
Prof. Dr. Winfried Rief, Department of Clinical Psychology and Psychotherapy
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