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Biofeedback-Based Cognitive Behavioral Treatment for Temporomandibular Disorders
This study is currently recruiting participants.
Verified by Philipps University Marburg Medical Center, October 2008
First Received: October 8, 2008   Last Updated: October 9, 2008   History of Changes
Sponsors and Collaborators: Philipps University Marburg Medical Center
Psychotherapie-Ambulanz Marburg e.V.
Information provided by: Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier: NCT00769561
  Purpose

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
Temporomandibular Disorders
Behavioral: Biofeedback-Based Cognitive Behavioral Treatment
Device: Interocclusal splint therapy
Phase II
Phase III

MedlinePlus related topics: Temporomandibular Joint Dysfunction
U.S. FDA Resources
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.

Further study details as provided by Philipps University Marburg Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

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
1: Experimental
Biofeedback-based cognitive behavioral treatment
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.
2: Active Comparator
Interocclusal splint therapy
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.

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00769561

Contacts
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

Locations
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    
Sponsors and Collaborators
Philipps University Marburg Medical Center
Psychotherapie-Ambulanz Marburg e.V.
Investigators
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
  More Information

Additional Information:
No publications provided

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

Keywords provided by Philipps University Marburg Medical Center:
Biofeedback
Cognitive behavioral therapy
Pain
Temporomandibular disorders

Study placed in the following topic categories:
Temporomandibular Joint Disorders
Muscular Diseases
Musculoskeletal Diseases
Temporomandibular Joint Dysfunction Syndrome
Myofascial Pain Syndromes
Fibromyalgia
Craniomandibular Disorders
Joint Diseases
Salicylic Acid
Pain
Stomatognathic Diseases

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on March 16, 2009