A Phase 2/3 interventional study of Biofeedback-Based Cognitive Behavioral Treatment and Dental treatment with occlusal splint (OS) in Temporomandibular Disorders, sponsored by Philipps University Marburg. Completed at 2 sites in Germany. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2013-12-30.
Sponsored by Philipps University Marburg · Phase 2/3, Interventional, and Treatment
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.
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.
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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
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)
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up
Somatoform Symptoms (Screening for Somatoform Disorders, SOMS)
Somatoform complaints during the past week were assessed using the Screening for Somatoform Symptoms (SOMS-7). 32 medically unexplained symptoms (29 for male subjects) representing DSM-IV criteria for somatization disorder were rated on a 0 ('not at all') to 4 ('very much') scale (range 0 - 128 for women and 0 - 116 for men). A sum score was calculated with higher scores indicating higher intensity and burden of somatoform complaints. In the current sample, Cronbach's alpha level was α = .88.
Time frame: 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)
Depressive symptoms were measured using the Centre for Epidemiological Studies Depression scale (CES-D). The CES-D asks for the frequency of 20 symptoms of depression during the past week on a scale ranging from 0 ('less than 1 day') to 3 ('5 to 7 days') (range 0-60). Higher scores indicate more depressive symptoms. It is suitable for use in chronic pain patients as it relies less on physical symptoms of depression than do other measures. Cronbach's alpha level in the current sample was α = .89.
Time frame: Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up
General Anxiety Symptoms (GAD-7)
General anxiety symptoms were assessed using the 7-item scale from the Patient Health Questionnaire (GAD-7). The GAD-7 asks for anxiety symptoms during the past month on a 1 ('not at all') to 3 ('more than half of the days') rating scale (range 7-21). Higher scores indicate higher levels of anxiety. Cronbach's alpha level in the current sample was α = .64.
Time frame: Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up
Pain Coping (FESV)
Cognitive and behavioral pain coping strategies were assessed with Coping Strategies Scale from the German Pain Coping Questionnaire (Fragebogen zur Erfassung der Schmerzverarbeitung, FESV). The scale asks for the use of 24 cognitive (e.g. cognitive restructuring) and behavioral (e.g. use of relaxation techniques) strategies for coping with pain on a scale ranging from 1 ('fully disagree') to 6 ('fully agree') (range 24-144). A sum score was used with higher scores indicating more adaptive coping. Cronbach's alpha level was α = .80.
Time frame: Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up
TMD Related Symptoms
TMD related symptoms, such as jaw pain, toothache or dizziness, were measured using a 41-item TMD symptom list. Following the SOMS-7 scale, intensity of symptoms experienced during the past week was rated from 0 ('not at all') to 4 ('very high intensity') (range 0 - 164). A sum score was built with higher scores indicating higher intensity of TMD related symptoms. The TMD symptom list has not been evaluated previously; however, large bivariate correlations with somatization (Pearson's r = .79), medium to large correlations with pain intensity (r = .48), and medium correlations with depression (r = .37) and anxiety (r = .27) provide evidence of good convergent and divergent validity. Cronbach's alpha level in the current sample was excellent (α = .93).
Time frame: Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment, and 6-months follow up
Location: Department of Prosthetic Dentistry and the Department of Oral and Maxillofacial Surgery, Marburg Dental School, Philipps University of Marburg, Germany Patient recruitment and follow-up assessment period: August 2008 to April 2011.
| Milestone | BFB-CBT | Occlusal Splint |
|---|---|---|
| Started | 29 | 29 |
| Completed | 26 | 24 |
| Not completed | 3 | 5 |
| Withdrew: Withdrawal by subject | 2 | 2 |
| Withdrew: Lost to follow-up | 1 | 3 |
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.
| units on a scale | BFB-CBT | Occlusal Splint |
|---|---|---|
| Pre-Treatment pain intensity | 5.40 ± 1.94 | 5.53 ± 1.97 |
| Post-Treatment pain intensity (after 8 weeks) | 3.90 ± 2.19 | 3.89 ± 2.40 |
| 6-months follow up pain intensity | 3.62 ± 2.48 | 4.21 ± 2.50 |
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.
| units on a scale | BFB-CBT | Occlusal Splint |
|---|---|---|
| Pre-Treatment pain disability | 17.67 ± 12.75 | 13.88 ± 13.18 |
| Post-Treatment pain disability (after 8 weeks) | 11.07 ± 12.01 | 11.62 ± 12.26 |
| 6-months follow up pain disability | 13.24 ± 11.96 | 11.61 ± 11.91 |
Somatoform complaints during the past week were assessed using the Screening for Somatoform Symptoms (SOMS-7). 32 medically unexplained symptoms (29 for male subjects) representing DSM-IV criteria for somatization disorder were rated on a 0 ('not at all') to 4 ('very much') scale (range 0 - 128 for women and 0 - 116 for men). A sum score was calculated with higher scores indicating higher intensity and burden of somatoform complaints. In the current sample, Cronbach's alpha level was α = .88.
| units on a scale | BFB-CBT | Occlusal Splint |
|---|---|---|
| Pre-Treatment Somatoform symptoms | 14.97 ± 13.63 | 11.81 ± 7.57 |
| Post-Treatment Somatoform symptoms (after 8 weeks) | 10.64 ± 10.16 | 11.30 ± 9.67 |
| 6-months follow up Somatoform symptoms | 10.69 ± 9.67 | 9.81 ± 7.91 |
Depressive symptoms were measured using the Centre for Epidemiological Studies Depression scale (CES-D). The CES-D asks for the frequency of 20 symptoms of depression during the past week on a scale ranging from 0 ('less than 1 day') to 3 ('5 to 7 days') (range 0-60). Higher scores indicate more depressive symptoms. It is suitable for use in chronic pain patients as it relies less on physical symptoms of depression than do other measures. Cronbach's alpha level in the current sample was α = .89.
| units on a scale | BFB-CBT | Occlusal Splint |
|---|---|---|
| Pre-Treatment Depressive symptoms | 18.51 ± 11.72 | 17.38 ± 8.05 |
| Post-Treatment Depressive symptoms (after 8 weeks) | 13.05 ± 8.88 | 16.09 ± 8.95 |
| 6-months follow up Depressive symptoms | 15.05 ± 11.86 | 16.67 ± 10.07 |
General anxiety symptoms were assessed using the 7-item scale from the Patient Health Questionnaire (GAD-7). The GAD-7 asks for anxiety symptoms during the past month on a 1 ('not at all') to 3 ('more than half of the days') rating scale (range 7-21). Higher scores indicate higher levels of anxiety. Cronbach's alpha level in the current sample was α = .64.
| units on a scale | BFB-CBT | Occlusal Splint |
|---|---|---|
| Pre-treatment anxiety | 15.15 ± 2.62 | 14.15 ± 2.35 |
| Post-Treatment anxiety (after 8 weeks) | 13.07 ± 3.44 | 13.33 ± 3.03 |
| 6-months follow up anxiety | 12.79 ± 3.27 | 13.04 ± 2.92 |
Cognitive and behavioral pain coping strategies were assessed with Coping Strategies Scale from the German Pain Coping Questionnaire (Fragebogen zur Erfassung der Schmerzverarbeitung, FESV). The scale asks for the use of 24 cognitive (e.g. cognitive restructuring) and behavioral (e.g. use of relaxation techniques) strategies for coping with pain on a scale ranging from 1 ('fully disagree') to 6 ('fully agree') (range 24-144). A sum score was used with higher scores indicating more adaptive coping. Cronbach's alpha level was α = .80.
| units on a scale | BFB-CBT | Occlusal Splint |
|---|---|---|
| Pre-Treatment Pain Coping | 62.15 ± 14.49 | 59.35 ± 14.56 |
| Post-Treatment Pain Coping (after 8 weeks) | 81.80 ± 19.86 | 64.69 ± 20.22 |
| 6-months follow up Pain Coping | 77.11 ± 21.04 | 60.13 ± 18.90 |
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.
| units on a scale | BFB-CBT | Occlusal Splint |
|---|---|---|
| Pre-Treatment Jaw use limitations | 25.87 ± 21.29 | 27.04 ± 16.23 |
| Post-Treatment Jaw use limitations (after 8 weeks) | 18.52 ± 17.94 | 18.77 ± 14.47 |
| 6-months follow up Jaw use limitations | 18.39 ± 16.84 | 18.11 ± 18.02 |
TMD related symptoms, such as jaw pain, toothache or dizziness, were measured using a 41-item TMD symptom list. Following the SOMS-7 scale, intensity of symptoms experienced during the past week was rated from 0 ('not at all') to 4 ('very high intensity') (range 0 - 164). A sum score was built with higher scores indicating higher intensity of TMD related symptoms. The TMD symptom list has not been evaluated previously; however, large bivariate correlations with somatization (Pearson's r = .79), medium to large correlations with pain intensity (r = .48), and medium correlations with depression (r = .37) and anxiety (r = .27) provide evidence of good convergent and divergent validity. Cronbach's alpha level in the current sample was excellent (α = .93).
| units on a scale | BFB-CBT | Occlusal Splint |
|---|---|---|
| Pre-Treatment TMD related symptoms | 47.69 ± 24.12 | 37.44 ± 17.28 |
| Post-Treatment TMD related symptoms (at 8 weeks) | 34.34 ± 22.53 | 28.15 ± 11.46 |
| 6-months follow up TMD related symptoms | 35.97 ± 23.38 | 28.73 ± 14.89 |
Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| BFB-CBT | — | 0/29 (0%) | 3/29 (10.3%) |
| Occlusal Splint | — | 0/29 (0%) | 7/29 (24.1%) |
| Event | BFB-CBT | Occlusal Splint |
|---|---|---|
| Pain in head and/or backMusculoskeletal and connective tissue disorders | 0/29 | 2/29 |
| Pain in teethNervous system disorders | 1/29 | 1/29 |
| Jaw painMusculoskeletal and connective tissue disorders | 1/29 | 0/29 |
| Limited jaw motionMusculoskeletal and connective tissue disorders | 1/29 | 1/29 |
| Higher muscle tensionMusculoskeletal and connective tissue disorders | 0/29 | 1/29 |
| Ear painEar and labyrinth disorders | 0/29 | 1/29 |
| TinnitusEar and labyrinth disorders | 0/29 | 1/29 |
| Age, Continuous(years) | BFB-CBT | Occlusal Splint | Total |
|---|---|---|---|
| Mean | 36.3 ± 13.4 | 34.3 ± 12.5 | 35.3 ± 12.9 |
| Sex: Female, Male(Participants) | BFB-CBT | Occlusal Splint | Total |
|---|---|---|---|
| Female | 25 | 20 | 45 |
| Male | 4 | 9 | 13 |
| Region of Enrollment(participants) | BFB-CBT | Occlusal Splint | Total |
|---|---|---|---|
| Germany | 29 | 29 | 58 |
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Temporomandibular Joint Disorders→
Philipps University Marburg