Biofeedback-Based Cognitive Behavioral Treatment for Temporomandibular Disorders
Condition: Temporomandibular Disorders
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

Intervention name(s): Biofeedback-Based Cognitive Behavioral Treatment; Dental treatment with occlusal splint (OS)
Intervention type(s): Behavioral; Device
Intervention description(s): 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.; 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.
Intervention MeSH terms: Salicylic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Temporomandibular disorders; Biofeedback; Cognitive behavioral therapy; Pain