Evaluation of Biofeedback Therapy Efficiency in Masticatory Muscles Pain Management
NCT ID: NCT03421028
Last Updated: 2021-07-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2022-01-01
2024-12-31
Brief Summary
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Detailed Description
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The aim of the study is to evaluate beneficial effects of biofeedback therapy in reducing pain, increased tension of masticatory muscles occurring in patients with myogenous TMD and if the therapy influences psychological and sleep parameters. Also to verify if the effect of the therapy persists in time.
2. Patients:
1. Experimental group 1 - patients diagnosed with myalgia subjected to 4 EMG-Biofeedback trainings. The group will include approximately 20 adults.
2. Experimental group 2 - patients diagnosed with myalgia subjected to 8 EMG-Biofeedback trainings. The group will include approximately 20 adults.
3. Control group - patients diagnosed with myalgia subjected to physiotherapy (manual therapy), stabilization splint usage and counseling (20 adults).
3. Methods:
Adult patients diagnosed with masticatory muscles myalgia will be included in this study. All participants will be evaluated in accordance to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD). Intensity of pain in the masticatory muscles will be defined using the Numerical Rating Scale (NRS). The pressure pain threshold (PPT) will be assessed with an dolorimeter and noticed on DC/TMD pain drawing diagram. Each of the qualified patients will also undergo the electromyography of temporal and masseter muscles. All participants will fill in questionnaires (Graded Chronic Pain Scale (GCPS), Pittsburgh Sleep Quality Index (PSQI), Patient Health Questionnaire-9 (PHQ-9), Beck Anxiety Inventory (BAI) and Perceived Stress Scale-10 (PSS-10) and Somatic Symptom Scale-8 (SSS-8).
Patients qualified to the experimental groups will be divided in to 2 subgroups composed of 20 participants each.
Experimental group 1 will undergo a cycle of 4 meetings (1 per week) of 20 minute EMG-Biofeedback- assisted training decreasing the masseter and temporalis muscle tension. 10 minutes of training for each group of muscle.
Experimental group 2 will undergo a cycle of 8 meetings (1 per week) of 20 minute EMG-Biofeedback- assisted training decreasing the masseter and temporalis muscle tension. 10 minutes of training for each group of muscle.
Postcycle examination:
After completing the cycle, patients from the study group and control group will be reevaluated. All participants will be evaluated in accordance to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD). Intensity of pain in the masticatory muscles will be defined using the Numerical Rating Scale (NRS). The pressure pain threshold (PPT) will be assessed with an dolorimeter and noticed on DC/TMD pain drawing diagram. Each of the qualified patients will also undergo the electromyography of temporal and masseter muscles. All participants will fill in questionnaires (Graded Chronic Pain Scale (GCPS), Pittsburgh Sleep Quality Index (PSQI), Patient Health Questionnaire-9 (PHQ-9), Beck Anxiety Inventory (BAI) and Perceived Stress Scale-10 (PSS-10) and Somatic Symptom Scale-8 (SSS-8).
The postcycle examination will take place after last planned training and during follow-ups - 6 and 12 weeks after completion of EMG-Biofeedback therapy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control group
Patients with masticatory muscle pain treated with occlusal splint, physiotherapy and counseling
Classic treatment for myogenous TMD
Combination of physiotherapy (manual therapy), stabilization occlusal splint usage and counseling
Experimental group 1
Patients diagnosed with masticatory muscle pain treated with 4 meetings of EMG-biofeedback assisted training
Electromyography Biofeedback
EMG-Biofeedback- assisted training is a method in which electrodes situated on the surface of the skin detect small voltage changes which arise from the working muscles (in this case masseter and temporalis muscles). The voltage is transformed into a visual or sound time-variable signal which gives the patient feedback as he willingly tries to change the muscle tension (in this case to lower the excessive masseter tension)
Experimental group 2
Patients diagnosed with masticatory muscle pain treated with 8 meetings of EMG-biofeedback
Electromyography Biofeedback
EMG-Biofeedback- assisted training is a method in which electrodes situated on the surface of the skin detect small voltage changes which arise from the working muscles (in this case masseter and temporalis muscles). The voltage is transformed into a visual or sound time-variable signal which gives the patient feedback as he willingly tries to change the muscle tension (in this case to lower the excessive masseter tension)
Interventions
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Electromyography Biofeedback
EMG-Biofeedback- assisted training is a method in which electrodes situated on the surface of the skin detect small voltage changes which arise from the working muscles (in this case masseter and temporalis muscles). The voltage is transformed into a visual or sound time-variable signal which gives the patient feedback as he willingly tries to change the muscle tension (in this case to lower the excessive masseter tension)
Classic treatment for myogenous TMD
Combination of physiotherapy (manual therapy), stabilization occlusal splint usage and counseling
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* full dentition or single tooth loss
* age between 18 and 70
Exclusion Criteria
* age over 70
* terminal general diseases
* severe mental disorders
* severe neurological disorders
* intake of drugs affecting muscle function
* edentulism or destruction of dentition
* alcoholism
* drug addiction
* history of severe trauma in the head and neck region
* severe pathology of temporomandibular joints
* congenital or acquired craniofacial deformity
* patients suffering from neuropathic pain
* patients with craniofacial inflammation
* patients undergoing orthodontic treatment
* pregnancy
* significant postural defect
18 Years
70 Years
ALL
No
Sponsors
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Wroclaw Medical University
OTHER
Responsible Party
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Wojciech Florjański
Principal Investigator
Principal Investigators
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Mieszko Więckiewicz, D.M.D.Ph.D.
Role: STUDY_CHAIR
Wroclaw Medical University
Locations
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Wroclaw Medical University
Wroclaw, Dolny Śląsk, Poland
Countries
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Central Contacts
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Other Identifiers
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WMU2/2017
Identifier Type: -
Identifier Source: org_study_id
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