Clinical trial NCT00769561: Biofeedback-Based Cognitive Behavioral Treatment for Temporomandibular Disorders
Official title: Comparison of a Biofeedback-Based Cognitive Behavioral Treatment and Occlusal Splint Therapy for Temporomandibular Disorders. A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Temporomandibular Disorders
Keywords: Temporomandibular disorders
Biofeedback
Cognitive behavioral therapy
Pain
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
Collaborators: name: Psychotherapie-Ambulanz Marburg e.V.
First posted: 2008-10-09
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Pain Intensity (German Pain Questionnaire; Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD))
timeFrame: Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up
measure: Pain Disability (Pain Disability Index)
timeFrame: Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up
measure: Jaw Use Limitations (JDL)
timeFrame: Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up
Secondary outcomes:
measure: Somatoform Symptoms (Screening for Somatoform Disorders, SOMS)
timeFrame: Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up
measure: Depressive Symptoms (Centers for Epidemiologic Studies Depression Scale)
timeFrame: Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up
measure: General Anxiety Symptoms (GAD-7)
timeFrame: Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up
measure: Pain Coping (FESV)
timeFrame: Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up
measure: TMD Related Symptoms
timeFrame: Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment, and 6-months follow up
Other outcomes:
Locations:
city: Marburg
country: Germany
facility: Department of Clinical Psychology and Psychotherapy, Philipps University Marburg
city: Marburg
country: Germany
facility: Department of Oral and Maxillofacial Surgery, Philipps University Marburg Medical Center
Study officials:
affiliation: Department of Clinical Psychology and Psychotherapy, Philipps University Marburg, Germany
name: Winfried Rief, Prof. Dr.
role: STUDY_CHAIR
affiliation: Department of Clinical Psychology and Psychotherapy, Philipps University Marburg, Germany
name: Gaby M Bleichhardt, Dr. (PhD)
role: STUDY_DIRECTOR
affiliation: Department of Clinical Psychology and Psychotherapy, Philipps University Marburg, Germany
name: Meike C Shedden Mora, Dipl. Psych.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shedden Mora MC, Weber D, Neff A, Rief W. Biofeedback-based cognitive-behavioral treatment compared with occlusal splint for temporomandibular disorder: a randomized controlled trial. Clin J Pain. 2013 Dec;29(12):1057-65. doi: 10.1097/AJP.0b013e3182850559.
citation: Shedden Mora M, Weber D, Borkowski S, Rief W. Nocturnal masseter muscle activity is related to symptoms and somatization in temporomandibular disorders. J Psychosom Res. 2012 Oct;73(4):307-12. doi: 10.1016/j.jpsychores.2012.07.008. Epub 2012 Aug 29.
citation: Shedden Mora, M., Bleichhardt, G., Weber, D., Neff, A., & Rief, W. (2010). Biofeedback bei kraniomandibulären Dysfunktionen. Psychotherapeut, 55(3), 217-224.