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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ2
- フェーズ 3
連絡先と場所
研究場所
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Marburg、ドイツ、35032
- Department of Clinical Psychology and Psychotherapy, Philipps University Marburg
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Marburg、ドイツ、35032
- Department of Oral and Maxillofacial Surgery, Philipps University Marburg Medical Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：BFB-CBT
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. |
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.
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アクティブコンパレータ：Occlusal Splint (OS)
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. |
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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Pain Intensity (German Pain Questionnaire; Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD))
時間枠：Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up
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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. |
Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up
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Pain Disability (Pain Disability Index)
時間枠：Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up
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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.
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Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up
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Jaw Use Limitations (JDL)
時間枠：Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up
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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.
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Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Somatoform Symptoms (Screening for Somatoform Disorders, SOMS)
時間枠：Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up
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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.
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Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up
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Depressive Symptoms (Centers for Epidemiologic Studies Depression Scale)
時間枠：Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up
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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.
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Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up
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General Anxiety Symptoms (GAD-7)
時間枠：Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up
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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.
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Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up
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Pain Coping (FESV)
時間枠：Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up
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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.
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Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up
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TMD Related Symptoms
時間枠：Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment, and 6-months follow up
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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).
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Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment, and 6-months follow up
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協力者と研究者
捜査官
- スタディチェア：Winfried Rief, Prof. Dr.、Department of Clinical Psychology and Psychotherapy, Philipps University Marburg, Germany
- スタディディレクター：Gaby M Bleichhardt, Dr. (PhD)、Department of Clinical Psychology and Psychotherapy, Philipps University Marburg, Germany
- 主任研究者：Meike C Shedden Mora, Dipl. Psych.、Department of Clinical Psychology and Psychotherapy, Philipps University Marburg, Germany
出版物と役立つリンク
一般刊行物
- 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.
- 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.
- Shedden Mora, M., Bleichhardt, G., Weber, D., Neff, A., & Rief, W. (2010). Biofeedback bei kraniomandibulären Dysfunktionen. Psychotherapeut, 55(3), 217-224.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
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QC基準を満たした最初の提出物
最初の投稿 (見積もり)
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最終確認日
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