Trial Outcomes & Findings for Biofeedback-Based Cognitive Behavioral Treatment for Temporomandibular Disorders (NCT NCT00769561)

NCT ID: NCT00769561

Last Updated: 2013-12-30

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 58 participants
• Primary outcome timeframe: Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up
• Results posted on: 2013-12-30

Participant Flow

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.

Participant milestones

Measure	BFB-CBT Biofeedback-based cognitive.behavioral treatment	Occlusal Splint Dental treatment with occlusal splint
Overall Study STARTED	29	29
Overall Study COMPLETED	26	24
Overall Study NOT COMPLETED	3	5

Reasons for withdrawal

Measure	BFB-CBT Biofeedback-based cognitive.behavioral treatment	Occlusal Splint Dental treatment with occlusal splint
Overall Study Withdrawal by Subject	2	2
Overall Study Lost to Follow-up	1	3

Baseline Characteristics

Biofeedback-Based Cognitive Behavioral Treatment for Temporomandibular Disorders

Baseline characteristics by cohort

Measure	BFB-CBT n=29 Participants Biofeedback-based cognitive.behavioral treatment	Occlusal Splint n=29 Participants Dental treatment with occlusal splint	Total n=58 Participants Total of all reporting groups
Age, Continuous	36.3 years STANDARD_DEVIATION 13.4 • n=5 Participants	34.3 years STANDARD_DEVIATION 12.5 • n=7 Participants	35.3 years STANDARD_DEVIATION 12.9 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	20 Participants n=7 Participants	45 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	9 Participants n=7 Participants	13 Participants n=5 Participants
Region of Enrollment Germany	29 participants n=5 Participants	29 participants n=7 Participants	58 participants n=5 Participants

PRIMARY outcome

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

Population: Intent-to-treat approach (ITT) with the last observation carried forward (LOCF)

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.

Outcome measures

Measure	BFB-CBT n=29 Participants Biofeedback-based cognitive.behavioral treatment	Occlusal Splint n=29 Participants Dental treatment with occlusal splint
Pain Intensity (German Pain Questionnaire; Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD)) Pre-Treatment pain intensity	5.40 units on a scale Standard Deviation 1.94	5.53 units on a scale Standard Deviation 1.97
Pain Intensity (German Pain Questionnaire; Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD)) Post-Treatment pain intensity (after 8 weeks)	3.90 units on a scale Standard Deviation 2.19	3.89 units on a scale Standard Deviation 2.40
Pain Intensity (German Pain Questionnaire; Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD)) 6-months follow up pain intensity	3.62 units on a scale Standard Deviation 2.48	4.21 units on a scale Standard Deviation 2.50

PRIMARY outcome

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

Population: Intent-to-treat approach (ITT) with the last observation carried forward (LOCF)

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.

Outcome measures

Measure	BFB-CBT n=29 Participants Biofeedback-based cognitive.behavioral treatment	Occlusal Splint n=29 Participants Dental treatment with occlusal splint
Pain Disability (Pain Disability Index) Pre-Treatment pain disability	17.67 units on a scale Standard Deviation 12.75	13.88 units on a scale Standard Deviation 13.18
Pain Disability (Pain Disability Index) Post-Treatment pain disability (after 8 weeks)	11.07 units on a scale Standard Deviation 12.01	11.62 units on a scale Standard Deviation 12.26
Pain Disability (Pain Disability Index) 6-months follow up pain disability	13.24 units on a scale Standard Deviation 11.96	11.61 units on a scale Standard Deviation 11.91

PRIMARY outcome

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

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.

Outcome measures

Measure	BFB-CBT n=29 Participants Biofeedback-based cognitive.behavioral treatment	Occlusal Splint n=29 Participants Dental treatment with occlusal splint
Jaw Use Limitations (JDL) Pre-Treatment Jaw use limitations	25.87 units on a scale Standard Deviation 21.29	27.04 units on a scale Standard Deviation 16.23
Jaw Use Limitations (JDL) Post-Treatment Jaw use limitations (after 8 weeks)	18.52 units on a scale Standard Deviation 17.94	18.77 units on a scale Standard Deviation 14.47
Jaw Use Limitations (JDL) 6-months follow up Jaw use limitations	18.39 units on a scale Standard Deviation 16.84	18.11 units on a scale Standard Deviation 18.02

SECONDARY outcome

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

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.

Outcome measures

Measure	BFB-CBT n=29 Participants Biofeedback-based cognitive.behavioral treatment	Occlusal Splint n=29 Participants Dental treatment with occlusal splint
Somatoform Symptoms (Screening for Somatoform Disorders, SOMS) Pre-Treatment Somatoform symptoms	14.97 units on a scale Standard Deviation 13.63	11.81 units on a scale Standard Deviation 7.57
Somatoform Symptoms (Screening for Somatoform Disorders, SOMS) Post-Treatment Somatoform symptoms (after 8 weeks)	10.64 units on a scale Standard Deviation 10.16	11.30 units on a scale Standard Deviation 9.67
Somatoform Symptoms (Screening for Somatoform Disorders, SOMS) 6-months follow up Somatoform symptoms	10.69 units on a scale Standard Deviation 9.67	9.81 units on a scale Standard Deviation 7.91

SECONDARY outcome

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

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.

Outcome measures

Measure	BFB-CBT n=29 Participants Biofeedback-based cognitive.behavioral treatment	Occlusal Splint n=29 Participants Dental treatment with occlusal splint
Depressive Symptoms (Centers for Epidemiologic Studies Depression Scale) Pre-Treatment Depressive symptoms	18.51 units on a scale Standard Deviation 11.72	17.38 units on a scale Standard Deviation 8.05
Depressive Symptoms (Centers for Epidemiologic Studies Depression Scale) Post-Treatment Depressive symptoms (after 8 weeks)	13.05 units on a scale Standard Deviation 8.88	16.09 units on a scale Standard Deviation 8.95
Depressive Symptoms (Centers for Epidemiologic Studies Depression Scale) 6-months follow up Depressive symptoms	15.05 units on a scale Standard Deviation 11.86	16.67 units on a scale Standard Deviation 10.07

SECONDARY outcome

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

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.

Outcome measures

Measure	BFB-CBT n=29 Participants Biofeedback-based cognitive.behavioral treatment	Occlusal Splint n=29 Participants Dental treatment with occlusal splint
General Anxiety Symptoms (GAD-7) Pre-treatment anxiety	15.15 units on a scale Standard Deviation 2.62	14.15 units on a scale Standard Deviation 2.35
General Anxiety Symptoms (GAD-7) Post-Treatment anxiety (after 8 weeks)	13.07 units on a scale Standard Deviation 3.44	13.33 units on a scale Standard Deviation 3.03
General Anxiety Symptoms (GAD-7) 6-months follow up anxiety	12.79 units on a scale Standard Deviation 3.27	13.04 units on a scale Standard Deviation 2.92

SECONDARY outcome

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

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.

Outcome measures

Measure	BFB-CBT n=29 Participants Biofeedback-based cognitive.behavioral treatment	Occlusal Splint n=29 Participants Dental treatment with occlusal splint
Pain Coping (FESV) Pre-Treatment Pain Coping	62.15 units on a scale Standard Deviation 14.49	59.35 units on a scale Standard Deviation 14.56
Pain Coping (FESV) Post-Treatment Pain Coping (after 8 weeks)	81.80 units on a scale Standard Deviation 19.86	64.69 units on a scale Standard Deviation 20.22
Pain Coping (FESV) 6-months follow up Pain Coping	77.11 units on a scale Standard Deviation 21.04	60.13 units on a scale Standard Deviation 18.90

SECONDARY outcome

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

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).

Outcome measures

Measure	BFB-CBT n=29 Participants Biofeedback-based cognitive.behavioral treatment	Occlusal Splint n=29 Participants Dental treatment with occlusal splint
TMD Related Symptoms Pre-Treatment TMD related symptoms	47.69 units on a scale Standard Deviation 24.12	37.44 units on a scale Standard Deviation 17.28
TMD Related Symptoms Post-Treatment TMD related symptoms (at 8 weeks)	34.34 units on a scale Standard Deviation 22.53	28.15 units on a scale Standard Deviation 11.46
TMD Related Symptoms 6-months follow up TMD related symptoms	35.97 units on a scale Standard Deviation 23.38	28.73 units on a scale Standard Deviation 14.89

Adverse Events

BFB-CBT

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Occlusal Splint

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	BFB-CBT n=29 participants at risk Biofeedback-based cognitive.behavioral treatment	Occlusal Splint n=29 participants at risk Dental treatment with occlusal splint
Nervous system disorders Pain in teeth	3.4% 1/29 • Number of events 1	3.4% 1/29 • Number of events 1
Musculoskeletal and connective tissue disorders Jaw pain	3.4% 1/29 • Number of events 1	0.00% 0/29
Musculoskeletal and connective tissue disorders Limited jaw motion	3.4% 1/29 • Number of events 1	3.4% 1/29 • Number of events 1
Musculoskeletal and connective tissue disorders Higher muscle tension	0.00% 0/29	3.4% 1/29 • Number of events 1
Musculoskeletal and connective tissue disorders Pain in head and/or back	0.00% 0/29	6.9% 2/29 • Number of events 2
Ear and labyrinth disorders Ear pain	0.00% 0/29	3.4% 1/29 • Number of events 1
Ear and labyrinth disorders Tinnitus	0.00% 0/29	3.4% 1/29 • Number of events 1

Additional Information

Dr. Meike Shedden Mora

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

Phone: +49-6421-282

Email: m.shedden@staff.uni-marburg.de

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place