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| Tracking Information | |||||||||||||
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| First Received Date ICMJE | October 8, 2008 | ||||||||||||
| Last Updated Date | October 9, 2008 | ||||||||||||
| Start Date ICMJE | June 2008 | ||||||||||||
| Estimated Primary Completion Date | July 2010 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
| Change History | Complete list of historical versions of study NCT00769561 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Biofeedback-Based Cognitive Behavioral Treatment for Temporomandibular Disorders | ||||||||||||
| Official Title ICMJE | Comparison of a Biofeedback-Based Cognitive Behavioral Treatment and Occlusal Splint Therapy for Temporomandibular Disorders. A Randomized Clinical Trial. | ||||||||||||
| Brief Summary | 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. |
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| 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. |
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| Study Phase | Phase II, Phase III | ||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||
| Study Design ICMJE | Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study | ||||||||||||
| Condition ICMJE | Temporomandibular Disorders | ||||||||||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||||||
| Estimated Enrollment ICMJE | 100 | ||||||||||||
| Estimated Completion Date | July 2010 | ||||||||||||
| Estimated Primary Completion Date | July 2010 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||
| Ages | 18 Years to 70 Years | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Germany | ||||||||||||
| Administrative Information | |||||||||||||
| NCT ID ICMJE | NCT00769561 | ||||||||||||
| Responsible Party | Prof. Dr. Winfried Rief, Department of Clinical Psychology and Psychotherapy | ||||||||||||
| Study ID Numbers ICMJE | TMD_Jue2008 | ||||||||||||
| Study Sponsor ICMJE | Philipps University Marburg Medical Center | ||||||||||||
| Collaborators ICMJE | Psychotherapie-Ambulanz Marburg e.V. | ||||||||||||
| Investigators ICMJE |
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| Information Provided By | Philipps University Marburg Medical Center | ||||||||||||
| Verification Date | October 2008 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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