Biofeedback-Based Cognitive Behavioral Treatment for Temporomandibular Disorders

Philipps University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Temporomandibular Disorders

Treatments: Device: Dental treatment with occlusal splint (OS); Behavioral: Biofeedback-Based Cognitive Behavioral Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT00769561

TMD_Jue2008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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58 participants in 2 patient groups

BFB-CBT

Experimental group

Description:

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.

Treatment:

Behavioral: Biofeedback-Based Cognitive Behavioral Treatment

Occlusal Splint (OS)

Active Comparator group

Description:

Dental treatment with occlusal splints: 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.

Treatment:

Device: Dental treatment with occlusal splint (OS)