Biofeedback-Based Cognitive Behavioral Treatment for Temporomandibular Disorders

NCT00769561 | Completed Phase 2 Results DMC

• 1 other identifier: TMD_Jue2008
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 2

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.

Conditions

Temporomandibular Disorders

Keywords

Temporomandibular disorders; Biofeedback; Cognitive behavioral therapy; Pain

Outcome Measures

Primary Outcomes (3)

• Pain Intensity (German Pain Questionnaire; Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD))

  Characteristic pain intensity (German Pain Questionnaire; Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD)): Characteristic pain intensity was calculated by averaging ratings of current pain, average pain, and worst pain in the past month on a numeric rating scale from 0 (no pain) to 10 (maximum pain), as recommended by RDC/TMD (range 0 - 10). Higher values indicate higher pain levels.

  Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up

• Pain Disability (Pain Disability Index)

  Pain related disability was assessed using the Pain Disability Index (PDI). The PDI is a brief self-rating scale which assesses the level of pain related disability in seven areas of daily life (e.g., social activity, self-care) on a 0 (no disability) -10 (maximum disability) numeric rating scale (range 0 - 70). Higher values indicate higher disability levels. Cronbach's alpha was .87 in the current sample.

  Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up

• Jaw Use Limitations (JDL)

  Jaw use limitations were measured using the Jaw Disability List (JDL) from the RDC/TMD. The JDL asks the patient to rate interference with eleven oral activities, for example chewing or talking. We used an 11-point numeric rating scale (from 0 'no limitation' to 10 'maximum limitation') instead of ratings of 'yes' and 'no' (range 0 - 110). Higher values indicate higher levels of jaw use limitations. Cronbach's alpha was .86 in the current sample.

  Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up

Secondary Outcomes (5)

• Somatoform Symptoms (Screening for Somatoform Disorders, SOMS)

  Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up

• Depressive Symptoms (Centers for Epidemiologic Studies Depression Scale)

  Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up

• General Anxiety Symptoms (GAD-7)

  Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up

• Pain Coping (FESV)

  Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up

• TMD Related Symptoms

  Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment, and 6-months follow up

Study Arms (2)

BFB-CBT

EXPERIMENTAL

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.

Behavioral: Biofeedback-Based Cognitive Behavioral Treatment

Occlusal Splint (OS)

ACTIVE COMPARATOR

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.

Device: Dental treatment with occlusal splint (OS)

Interventions

Biofeedback-Based Cognitive Behavioral Treatment BEHAVIORAL

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.

BFB-CBT

Dental treatment with occlusal splint (OS) DEVICE

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.

Occlusal Splint (OS)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Philipps University Marburg: lead
• Psychotherapie-Ambulanz Marburg e.V.: collaborator

Study Sites (2)

Department of Clinical Psychology and Psychotherapy, Philipps University Marburg

Marburg, 35032, Germany

Location

Department of Oral and Maxillofacial Surgery, Philipps University Marburg Medical Center

Marburg, 35032, Germany

Location

Related Publications (3)

• 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.

  PMID: 23446073 RESULT

• 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.

  PMID: 22980538 RESULT

• Shedden Mora, M., Bleichhardt, G., Weber, D., Neff, A., & Rief, W. (2010). Biofeedback bei kraniomandibulären Dysfunktionen. Psychotherapeut, 55(3), 217-224.

  RESULT

Related Links

• Department of Clinical Psychology and Psychotherapy

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Pain

Interventions

Dental Care; Occlusal Splints

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dentistry; Dental Health Services; Health Services; Health Care Facilities Workforce and Services; Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Results Point of Contact

• Title: Dr. Meike Shedden Mora
• Organization: Department of Clinical Psychology and Psychotherapy, Philipps University of Marburg, Germany

m.shedden@staff.uni-marburg.de

+49-6421-282

Study Officials

• Winfried Rief, Prof. Dr.

  Department of Clinical Psychology and Psychotherapy, Philipps University Marburg, Germany

  STUDY CHAIR

• Gaby M Bleichhardt, Dr. (PhD)

  Department of Clinical Psychology and Psychotherapy, Philipps University Marburg, Germany

  STUDY DIRECTOR

• Meike C Shedden Mora, Dipl. Psych.

  Department of Clinical Psychology and Psychotherapy, Philipps University Marburg, Germany

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: October 8, 2008
• First Posted: October 9, 2008
• Study Start: August 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: April 1, 2011
• Last Updated: December 30, 2013
• Results First Posted: December 30, 2013

Record last verified: 2013-12

Locations

DE (2)