Ignite Creation Date:
2025-12-24 @ 12:53 PM
Ignite Modification Date:
2025-12-30 @ 3:42 AM
Study NCT ID:
NCT00769561
Status:
COMPLETED
Last Update Posted:
2013-12-30
First Post:
2008-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Biofeedback-Based Cognitive Behavioral Treatment for Temporomandibular Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013705', 'term': 'Temporomandibular Joint Disorders'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D017271', 'term': 'Craniomandibular Disorders'}, {'id': 'D008336', 'term': 'Mandibular Diseases'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003729', 'term': 'Dental Care'}, {'id': 'D017090', 'term': 'Occlusal Splints'}], 'ancestors': [{'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D003752', 'term': 'Dental Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D009989', 'term': 'Orthotic Devices'}, {'id': 'D009983', 'term': 'Orthopedic Equipment'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'm.shedden@staff.uni-marburg.de', 'phone': '+49-6421-282', 'title': 'Dr. Meike Shedden Mora', 'phoneExt': '3657', 'organization': 'Department of Clinical Psychology and Psychotherapy, Philipps University of Marburg, Germany'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'BFB-CBT', 'description': 'Biofeedback-based cognitive.behavioral treatment', 'otherNumAtRisk': 29, 'otherNumAffected': 3, 'seriousNumAtRisk': 29, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Occlusal Splint', 'description': 'Dental treatment with occlusal splint', 'otherNumAtRisk': 29, 'otherNumAffected': 7, 'seriousNumAtRisk': 29, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Pain in teeth', 'notes': 'Patient reported symptom aggravation, namely pain in teeth.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Jaw pain', 'notes': 'Patient reported symptom aggravation, namely jaw pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Limited jaw motion', 'notes': 'Patient reported symptom aggravation, namely limited jaw motion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Higher muscle tension', 'notes': 'Patient reported symptom aggravation, namely higher muscle tension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain in head and/or back', 'notes': 'Patient reported symptom aggravation, namely aggravation of pain in head and/or back', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ear pain', 'notes': 'Patient reported symptom aggravation, namely ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tinnitus', 'notes': 'Patient reported aggravation of pre-existing tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain Intensity (German Pain Questionnaire; Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD))', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BFB-CBT', 'description': 'Biofeedback-based cognitive.behavioral treatment'}, {'id': 'OG001', 'title': 'Occlusal Splint', 'description': 'Dental treatment with occlusal splint'}], 'classes': [{'title': 'Pre-Treatment pain intensity', 'categories': [{'measurements': [{'value': '5.40', 'spread': '1.94', 'groupId': 'OG000'}, {'value': '5.53', 'spread': '1.97', 'groupId': 'OG001'}]}]}, {'title': 'Post-Treatment pain intensity (after 8 weeks)', 'categories': [{'measurements': [{'value': '3.90', 'spread': '2.19', 'groupId': 'OG000'}, {'value': '3.89', 'spread': '2.40', 'groupId': 'OG001'}]}]}, {'title': '6-months follow up pain intensity', 'categories': [{'measurements': [{'value': '3.62', 'spread': '2.48', 'groupId': 'OG000'}, {'value': '4.21', 'spread': '2.50', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up', 'description': 'Characteristic pain intensity (German Pain Questionnaire; Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD)):\n\nCharacteristic 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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat approach (ITT) with the last observation carried forward (LOCF)'}, {'type': 'PRIMARY', 'title': 'Pain Disability (Pain Disability Index)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BFB-CBT', 'description': 'Biofeedback-based cognitive.behavioral treatment'}, {'id': 'OG001', 'title': 'Occlusal Splint', 'description': 'Dental treatment with occlusal splint'}], 'classes': [{'title': 'Pre-Treatment pain disability', 'categories': [{'measurements': [{'value': '17.67', 'spread': '12.75', 'groupId': 'OG000'}, {'value': '13.88', 'spread': '13.18', 'groupId': 'OG001'}]}]}, {'title': 'Post-Treatment pain disability (after 8 weeks)', 'categories': [{'measurements': [{'value': '11.07', 'spread': '12.01', 'groupId': 'OG000'}, {'value': '11.62', 'spread': '12.26', 'groupId': 'OG001'}]}]}, {'title': '6-months follow up pain disability', 'categories': [{'measurements': [{'value': '13.24', 'spread': '11.96', 'groupId': 'OG000'}, {'value': '11.61', 'spread': '11.91', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up', 'description': "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.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat approach (ITT) with the last observation carried forward (LOCF)'}, {'type': 'SECONDARY', 'title': 'Somatoform Symptoms (Screening for Somatoform Disorders, SOMS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BFB-CBT', 'description': 'Biofeedback-based cognitive.behavioral treatment'}, {'id': 'OG001', 'title': 'Occlusal Splint', 'description': 'Dental treatment with occlusal splint'}], 'classes': [{'title': 'Pre-Treatment Somatoform symptoms', 'categories': [{'measurements': [{'value': '14.97', 'spread': '13.63', 'groupId': 'OG000'}, {'value': '11.81', 'spread': '7.57', 'groupId': 'OG001'}]}]}, {'title': 'Post-Treatment Somatoform symptoms (after 8 weeks)', 'categories': [{'measurements': [{'value': '10.64', 'spread': '10.16', 'groupId': 'OG000'}, {'value': '11.30', 'spread': '9.67', 'groupId': 'OG001'}]}]}, {'title': '6-months follow up Somatoform symptoms', 'categories': [{'measurements': [{'value': '10.69', 'spread': '9.67', 'groupId': 'OG000'}, {'value': '9.81', 'spread': '7.91', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up', 'description': "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.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Depressive Symptoms (Centers for Epidemiologic Studies Depression Scale)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BFB-CBT', 'description': 'Biofeedback-based cognitive.behavioral treatment'}, {'id': 'OG001', 'title': 'Occlusal Splint', 'description': 'Dental treatment with occlusal splint'}], 'classes': [{'title': 'Pre-Treatment Depressive symptoms', 'categories': [{'measurements': [{'value': '18.51', 'spread': '11.72', 'groupId': 'OG000'}, {'value': '17.38', 'spread': '8.05', 'groupId': 'OG001'}]}]}, {'title': 'Post-Treatment Depressive symptoms (after 8 weeks)', 'categories': [{'measurements': [{'value': '13.05', 'spread': '8.88', 'groupId': 'OG000'}, {'value': '16.09', 'spread': '8.95', 'groupId': 'OG001'}]}]}, {'title': '6-months follow up Depressive symptoms', 'categories': [{'measurements': [{'value': '15.05', 'spread': '11.86', 'groupId': 'OG000'}, {'value': '16.67', 'spread': '10.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up', 'description': "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.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'General Anxiety Symptoms (GAD-7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BFB-CBT', 'description': 'Biofeedback-based cognitive.behavioral treatment'}, {'id': 'OG001', 'title': 'Occlusal Splint', 'description': 'Dental treatment with occlusal splint'}], 'classes': [{'title': 'Pre-treatment anxiety', 'categories': [{'measurements': [{'value': '15.15', 'spread': '2.62', 'groupId': 'OG000'}, {'value': '14.15', 'spread': '2.35', 'groupId': 'OG001'}]}]}, {'title': 'Post-Treatment anxiety (after 8 weeks)', 'categories': [{'measurements': [{'value': '13.07', 'spread': '3.44', 'groupId': 'OG000'}, {'value': '13.33', 'spread': '3.03', 'groupId': 'OG001'}]}]}, {'title': '6-months follow up anxiety', 'categories': [{'measurements': [{'value': '12.79', 'spread': '3.27', 'groupId': 'OG000'}, {'value': '13.04', 'spread': '2.92', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up', 'description': "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.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Coping (FESV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BFB-CBT', 'description': 'Biofeedback-based cognitive.behavioral treatment'}, {'id': 'OG001', 'title': 'Occlusal Splint', 'description': 'Dental treatment with occlusal splint'}], 'classes': [{'title': 'Pre-Treatment Pain Coping', 'categories': [{'measurements': [{'value': '62.15', 'spread': '14.49', 'groupId': 'OG000'}, {'value': '59.35', 'spread': '14.56', 'groupId': 'OG001'}]}]}, {'title': 'Post-Treatment Pain Coping (after 8 weeks)', 'categories': [{'measurements': [{'value': '81.80', 'spread': '19.86', 'groupId': 'OG000'}, {'value': '64.69', 'spread': '20.22', 'groupId': 'OG001'}]}]}, {'title': '6-months follow up Pain Coping', 'categories': [{'measurements': [{'value': '77.11', 'spread': '21.04', 'groupId': 'OG000'}, {'value': '60.13', 'spread': '18.90', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up', 'description': "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.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Jaw Use Limitations (JDL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BFB-CBT', 'description': 'Biofeedback-based cognitive.behavioral treatment'}, {'id': 'OG001', 'title': 'Occlusal Splint', 'description': 'Dental treatment with occlusal splint'}], 'classes': [{'title': 'Pre-Treatment Jaw use limitations', 'categories': [{'measurements': [{'value': '25.87', 'spread': '21.29', 'groupId': 'OG000'}, {'value': '27.04', 'spread': '16.23', 'groupId': 'OG001'}]}]}, {'title': 'Post-Treatment Jaw use limitations (after 8 weeks)', 'categories': [{'measurements': [{'value': '18.52', 'spread': '17.94', 'groupId': 'OG000'}, {'value': '18.77', 'spread': '14.47', 'groupId': 'OG001'}]}]}, {'title': '6-months follow up Jaw use limitations', 'categories': [{'measurements': [{'value': '18.39', 'spread': '16.84', 'groupId': 'OG000'}, {'value': '18.11', 'spread': '18.02', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up', 'description': "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.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'TMD Related Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BFB-CBT', 'description': 'Biofeedback-based cognitive.behavioral treatment'}, {'id': 'OG001', 'title': 'Occlusal Splint', 'description': 'Dental treatment with occlusal splint'}], 'classes': [{'title': 'Pre-Treatment TMD related symptoms', 'categories': [{'measurements': [{'value': '47.69', 'spread': '24.12', 'groupId': 'OG000'}, {'value': '37.44', 'spread': '17.28', 'groupId': 'OG001'}]}]}, {'title': 'Post-Treatment TMD related symptoms (at 8 weeks)', 'categories': [{'measurements': [{'value': '34.34', 'spread': '22.53', 'groupId': 'OG000'}, {'value': '28.15', 'spread': '11.46', 'groupId': 'OG001'}]}]}, {'title': '6-months follow up TMD related symptoms', 'categories': [{'measurements': [{'value': '35.97', 'spread': '23.38', 'groupId': 'OG000'}, {'value': '28.73', 'spread': '14.89', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment, and 6-months follow up', 'description': "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).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BFB-CBT', 'description': 'Biofeedback-based cognitive.behavioral treatment'}, {'id': 'FG001', 'title': 'Occlusal Splint', 'description': 'Dental treatment with occlusal splint'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'BFB-CBT', 'description': 'Biofeedback-based cognitive.behavioral treatment'}, {'id': 'BG001', 'title': 'Occlusal Splint', 'description': 'Dental treatment with occlusal splint'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.3', 'spread': '13.4', 'groupId': 'BG000'}, {'value': '34.3', 'spread': '12.5', 'groupId': 'BG001'}, {'value': '35.3', 'spread': '12.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-04', 'studyFirstSubmitDate': '2008-10-08', 'resultsFirstSubmitDate': '2013-05-24', 'studyFirstSubmitQcDate': '2008-10-08', 'lastUpdatePostDateStruct': {'date': '2013-12-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-12-04', 'studyFirstPostDateStruct': {'date': '2008-10-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-12-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Intensity (German Pain Questionnaire; Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD))', 'timeFrame': 'Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up', 'description': 'Characteristic pain intensity (German Pain Questionnaire; Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD)):\n\nCharacteristic 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.'}, {'measure': 'Pain Disability (Pain Disability Index)', 'timeFrame': 'Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up', 'description': "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."}, {'measure': 'Jaw Use Limitations (JDL)', 'timeFrame': 'Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Somatoform Symptoms (Screening for Somatoform Disorders, SOMS)', 'timeFrame': 'Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up', 'description': "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."}, {'measure': 'Depressive Symptoms (Centers for Epidemiologic Studies Depression Scale)', 'timeFrame': 'Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up', 'description': "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."}, {'measure': 'General Anxiety Symptoms (GAD-7)', 'timeFrame': 'Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up', 'description': "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."}, {'measure': 'Pain Coping (FESV)', 'timeFrame': 'Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up', 'description': "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."}, {'measure': 'TMD Related Symptoms', 'timeFrame': 'Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment, and 6-months follow up', 'description': "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)."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Temporomandibular disorders', 'Biofeedback', 'Cognitive behavioral therapy', 'Pain'], 'conditions': ['Temporomandibular Disorders']}, 'referencesModule': {'references': [{'pmid': '23446073', 'type': 'RESULT', 'citation': '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': '22980538', 'type': 'RESULT', 'citation': '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.'}, {'type': 'RESULT', 'citation': 'Shedden Mora, M., Bleichhardt, G., Weber, D., Neff, A., & Rief, W. (2010). Biofeedback bei kraniomandibulären Dysfunktionen. Psychotherapeut, 55(3), 217-224.'}], 'seeAlsoLinks': [{'url': 'http://www.uni-marburg.de/fb04/ag-klin/forschung', 'label': 'Department of Clinical Psychology and Psychotherapy'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nAssessment 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.\n\nAdditionally, 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical diagnosis of painful temporomandibular disorder according to Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD)\n* symptoms persist at least 3 months\n* sufficient language skills\n\nExclusion Criteria:\n\n* somatic diagnosis that requires defined somatic treatment (e.g. occlusal interference)\n* presence of a psychotic disorder\n* presence of neurological disorders (e.g. dementia)\n* alcohol or substance abuse\n* presence of other pain condition of predominant severity'}, 'identificationModule': {'nctId': 'NCT00769561', 'briefTitle': 'Biofeedback-Based Cognitive Behavioral Treatment for Temporomandibular Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Philipps University Marburg'}, 'officialTitle': 'Comparison of a Biofeedback-Based Cognitive Behavioral Treatment and Occlusal Splint Therapy for Temporomandibular Disorders. A Randomized Clinical Trial.', 'orgStudyIdInfo': {'id': 'TMD_Jue2008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BFB-CBT', 'description': 'Biofeedback-based cognitive-behavioral treatment:\n\nThe 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.', 'interventionNames': ['Behavioral: Biofeedback-Based Cognitive Behavioral Treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Occlusal Splint (OS)', 'description': 'Dental treatment with occlusal splints:\n\nMaxillary 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.', 'interventionNames': ['Device: Dental treatment with occlusal splint (OS)']}], 'interventions': [{'name': 'Biofeedback-Based Cognitive Behavioral Treatment', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['BFB-CBT']}, {'name': 'Dental treatment with occlusal splint (OS)', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Occlusal Splint (OS)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35032', 'city': 'Marburg', 'country': 'Germany', 'facility': 'Department of Clinical Psychology and Psychotherapy, Philipps University Marburg', 'geoPoint': {'lat': 50.80904, 'lon': 8.77069}}, {'zip': '35032', 'city': 'Marburg', 'country': 'Germany', 'facility': 'Department of Oral and Maxillofacial Surgery, Philipps University Marburg Medical Center', 'geoPoint': {'lat': 50.80904, 'lon': 8.77069}}], 'overallOfficials': [{'name': 'Winfried Rief, Prof. Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Clinical Psychology and Psychotherapy, Philipps University Marburg, Germany'}, {'name': 'Gaby M Bleichhardt, Dr. (PhD)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Clinical Psychology and Psychotherapy, Philipps University Marburg, Germany'}, {'name': 'Meike C Shedden Mora, Dipl. Psych.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Clinical Psychology and Psychotherapy, Philipps University Marburg, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Philipps University Marburg', 'class': 'OTHER'}, 'collaborators': [{'name': 'Psychotherapie-Ambulanz Marburg e.V.', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Winfried Rief', 'investigatorAffiliation': 'Philipps University Marburg'}}}}