Ignite Creation Date:
2025-12-24 @ 12:53 PM
Ignite Modification Date:
2025-12-30 @ 3:42 AM
Study NCT ID:
NCT00769561
Status:
COMPLETED
Last Update Posted:
2013-12-30
First Post:
2008-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Biofeedback-Based Cognitive Behavioral Treatment for Temporomandibular Disorders
Sponsor:
Philipps University Marburg
Organization:
Study Overview
Official Title:
Comparison of a Biofeedback-Based Cognitive Behavioral Treatment and Occlusal Splint Therapy for Temporomandibular Disorders. A Randomized Clinical Trial.
Status:
COMPLETED
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 electromyographic (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.
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 electromyographic (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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: