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
Recruitment status was Recruiting
Sponsor:
Philipps University Marburg Medical Center
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Comparison of a Biofeedback-Based Cognitive Behavioral Treatment and Occlusal Splint Therapy for Temporomandibular Disorders. A Randomized Clinical Trial. |
Resource links provided by NLM:
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 |
|---|---|
|
Experimental: 1
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.
|
|
Active Comparator: 2
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: | Prof. Dr. Winfried Rief, Department of Clinical Psychology and Psychotherapy |
| ClinicalTrials.gov Identifier: | NCT00769561 History of Changes |
| Other Study ID Numbers: | TMD_Jue2008 |
| Study First Received: | October 8, 2008 |
| Last Updated: | October 9, 2008 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by Philipps University Marburg Medical Center:
|
Temporomandibular disorders Biofeedback Cognitive behavioral therapy Pain |
Additional relevant MeSH terms:
|
Temporomandibular Joint Disorders Temporomandibular Joint Dysfunction Syndrome Craniomandibular Disorders Mandibular Diseases Jaw Diseases |
Musculoskeletal Diseases Joint Diseases Muscular Diseases Stomatognathic Diseases Myofascial Pain Syndromes |
ClinicalTrials.gov processed this record on May 21, 2013