Phase 3
N=58
Biofeedback-Based Cognitive Behavioral Treatment for Temporomandibular Disorders
Temporomandibular Disorders
Bottom Line
View on ClinicalTrials.gov: NCT00769561 ↗Enrolled (actual)
58
Serious AEs
0.0%
Results posted
Dec 2013
Primary outcome: Primary: Pain Intensity (German Pain Questionnaire; Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD)) — 5.40; 5.53; 3.90; 3.89 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Biofeedback-Based Cognitive Behavioral Treatment (Behavioral); Dental treatment with occlusal splint (OS) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Philipps University Marburg
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Intensity (German Pain Questionnaire; Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD)) |
5.40; 5.53; 3.90; 3.89; 3.62; 4.21 | — |
| PRIMARY Pain Disability (Pain Disability Index) |
17.67; 13.88; 11.07; 11.62; 13.24; 11.61 | — |
| PRIMARY Jaw Use Limitations (JDL) |
25.87; 27.04; 18.52; 18.77; 18.39; 18.11 | — |
| SECONDARY Somatoform Symptoms (Screening for Somatoform Disorders, SOMS) |
14.97; 11.81; 10.64; 11.30; 10.69; 9.81 | — |
| SECONDARY Depressive Symptoms (Centers for Epidemiologic Studies Depression Scale) |
18.51; 17.38; 13.05; 16.09; 15.05; 16.67 | — |
| SECONDARY General Anxiety Symptoms (GAD-7) |
15.15; 14.15; 13.07; 13.33; 12.79; 13.04 | — |
| SECONDARY Pain Coping (FESV) |
62.15; 59.35; 81.80; 64.69; 77.11; 60.13 | — |
| SECONDARY TMD Related Symptoms |
47.69; 37.44; 34.34; 28.15; 35.97; 28.73 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00769561). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.