Biofeedback-Based Cognitive Behavioral Treatment for Temporomandibular Disorders

Comparison of a Biofeedback-Based Cognitive Behavioral Treatment and Occlusal Splint Therapy for Temporomandibular Disorders. A Randomized Clinical Trial.

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00769561

Enrollment

Registered

2008-10-09

Start date

2008-08-31

Completion date

2011-04-30

Last updated

2013-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Temporomandibular Disorders

Keywords

Temporomandibular disorders, Biofeedback, Cognitive behavioral therapy, Pain

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.

Detailed description

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.

Interventions

BEHAVIORALBiofeedback-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.

DEVICEDental treatment with occlusal splint (OS)

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Pain Intensity (German Pain Questionnaire; Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD))	Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up	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.
Pain Disability (Pain Disability Index)	Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up	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.
Jaw Use Limitations (JDL)	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.

Secondary

Measure	Time frame	Description
Pain Coping (FESV)	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.
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	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.
TMD Related Symptoms	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).
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	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.
General Anxiety Symptoms (GAD-7)	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.

Countries

Germany

Participant flow

Recruitment details

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.

Participants by arm

Arm	Count
BFB-CBT Biofeedback-based cognitive.behavioral treatment	29
Occlusal Splint Dental treatment with occlusal splint	29
Total	58

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	1	3
Overall Study	Withdrawal by Subject	2	2

Baseline characteristics

Characteristic	BFB-CBT	Occlusal Splint	Total
Age, Continuous	36.3 years STANDARD_DEVIATION 13.4	34.3 years STANDARD_DEVIATION 12.5	35.3 years STANDARD_DEVIATION 12.9
Region of Enrollment Germany	29 participants	29 participants	58 participants
Sex: Female, Male Female	25 Participants	20 Participants	45 Participants
Sex: Female, Male Male	4 Participants	9 Participants	13 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	3 / 29	7 / 29
serious Total, serious adverse events	0 / 29	0 / 29

Outcome results

Primary

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.