Biofeedback-Based Cognitive Behavioral Treatment for Temporomandibular Disorders

This study has been completed.
Sponsor:
Collaborator:
Psychotherapie-Ambulanz Marburg e.V.
Information provided by (Responsible Party):
Winfried Rief, Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier:
NCT00769561
First received: October 8, 2008
Last updated: December 4, 2013
Last verified: December 2013
Results First Received: May 24, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Temporomandibular Disorders
Interventions: Behavioral: Biofeedback-Based Cognitive Behavioral Treatment
Device: Dental treatment with occlusal splint (OS)

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Location: Department of Prosthetic Dentistry and the Department of Oral and Maxillofacial Surgery, Marburg Dental School, Philipps University of Marburg, Germany Patient recruitment and follow-up assessment period: August 2008 to April 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
BFB-CBT Biofeedback-based cognitive.behavioral treatment
Occlusal Splint Dental treatment with occlusal splint

Participant Flow:   Overall Study
    BFB-CBT     Occlusal Splint  
STARTED     29     29  
COMPLETED     26     24  
NOT COMPLETED     3     5  
Withdrawal by Subject                 2                 2  
Lost to Follow-up                 1                 3  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
BFB-CBT Biofeedback-based cognitive.behavioral treatment
Occlusal Splint Dental treatment with occlusal splint
Total Total of all reporting groups

Baseline Measures
    BFB-CBT     Occlusal Splint     Total  
Number of Participants  
[units: participants]
  29     29     58  
Age  
[units: years]
Mean ± Standard Deviation
  36.3  ± 13.4     34.3  ± 12.5     35.3  ± 12.9  
Gender  
[units: participants]
     
Female     25     20     45  
Male     4     9     13  
Region of Enrollment  
[units: participants]
     
Germany     29     29     58  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Pain Intensity (German Pain Questionnaire; Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD))   [ Time Frame: Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up ]

2.  Primary:   Pain Disability (Pain Disability Index)   [ Time Frame: Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up ]

3.  Primary:   Jaw Use Limitations (JDL)   [ Time Frame: Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up ]

4.  Secondary:   Somatoform Symptoms (Screening for Somatoform Disorders, SOMS)   [ Time Frame: Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up ]

5.  Secondary:   Depressive Symptoms (Centers for Epidemiologic Studies Depression Scale)   [ Time Frame: Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up ]

6.  Secondary:   General Anxiety Symptoms (GAD-7)   [ Time Frame: Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up ]

7.  Secondary:   Pain Coping (FESV)   [ Time Frame: Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up ]

8.  Secondary:   TMD Related Symptoms   [ Time Frame: Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment, and 6-months follow up ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Meike Shedden Mora
Organization: Department of Clinical Psychology and Psychotherapy, Philipps University of Marburg, Germany
phone: +49-6421-282 ext 3657
e-mail: m.shedden@staff.uni-marburg.de


Publications of Results:

Responsible Party: Winfried Rief, Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier: NCT00769561     History of Changes
Other Study ID Numbers: TMD_Jue2008
Study First Received: October 8, 2008
Results First Received: May 24, 2013
Last Updated: December 4, 2013
Health Authority: Germany: Ethics Commission