Evaluation of Biofeedback Therapy Efficiency in Masticatory Muscles Pain Management

Wroclaw Medical University

Status: Not yet enrolling

Conditions: Temporomandibular Disorder; Craniomandibular Disorders; Feedback, Psychological; Sleep; Muscle Pain

Treatments: Other: Classic treatment for myogenous TMD; Device: Electromyography Biofeedback

Study type: Interventional

Funder types: Other

Identifiers

NCT03421028

WMU2/2017

Details and patient eligibility

About

This study evaluates beneficial effects of biofeedback therapy in reducing pain and increased tension of muscles occurring in patients with temporomandibular disorders (TMD). During the study Electromyography Biofeedback (EMG-Biofeedback)- assisted training lowering muscle tension will be used. The patients will undergo 4 or 8 meetings of EMG-Biofeedback - assisted training Than the patients will be reevaluated after 6 and 12 weeks.

Full description

1. The Aim:

   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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of myalgia in accordance to Diagnostic Criteria for Temporomandibular Disorders
• full dentition or single tooth loss
• age between 18 and 70

Exclusion criteria

• age under 18
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Control group

Active Comparator group

Description:

Patients with masticatory muscle pain treated with occlusal splint, physiotherapy and counseling

Treatment:

Other: Classic treatment for myogenous TMD

Experimental group 1

Experimental group

Description:

Patients diagnosed with masticatory muscle pain treated with 4 meetings of EMG-biofeedback assisted training

Treatment:

Device: Electromyography Biofeedback

Experimental group 2

Experimental group

Description:

Patients diagnosed with masticatory muscle pain treated with 8 meetings of EMG-biofeedback

Treatment:

Device: Electromyography Biofeedback