Clinical trial NCT03421028: Evaluation of Biofeedback Therapy Efficiency in Masticatory Muscles Pain Management
Official title: The Evaluation of EMG-biofeedback Therapy Efficiency in Management of Masticatory Muscles Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Muscle Pain
Feedback, Psychological
Craniomandibular Disorders
Temporomandibular Disorder
Sleep
Lead sponsor: Wroclaw Medical University
Sponsor class: OTHER
First posted: 2018-02-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The effect of EMG biofeedback therapy on pain symptoms measured by Numerical Rating Scale (NRS) in Experimental group 1
timeFrame: before the treatment, after 4 weeks of training
measure: The effect of EMG biofeedback therapy on pain symptoms measured by Numerical Rating Scale (NRS) in Experimental group 2
timeFrame: before the treatment, after 8 weeks of training
measure: The effect of EMG biofeedback therapy on pain symptoms measured by pressure pain threshold in Experimental group 1
timeFrame: before the treatment, after 4 weeks of training
measure: The effect of EMG biofeedback therapy on pain symptoms measured by pressure pain threshold in Experimental group 2
timeFrame: before the treatment, after 8 weeks of training
Secondary outcomes:
measure: Effect of EMG biofeedback therapy on psychological parameters and its persistence in time measured by Beck Anxiety Inventory (BAI).
timeFrame: before the treatment and up to 12 weeks after completion of the treatment
measure: Effect of EMG biofeedback therapy on psychological parameters and its persistence in time measured by Patient Health Questionnaire-9 (PHQ-9)
timeFrame: before the treatment and up to 12 weeks after completion of the treatment
measure: Effect of EMG biofeedback therapy on psychological parameters and its persistence in time measured by Perceived Stress Scale-10 (PSS-10)
timeFrame: before the treatment and up to 12 weeks after completion of the treatment
measure: Effect of EMG biofeedback therapy on psychological parameters and its persistence in time measured by Somatic Symptom Scale-8 (SSS-8).
timeFrame: before the treatment and up to 12 weeks after completion of the treatment
measure: Effect of EMG biofeedback therapy on sleep quality and its persistence in time measured by Pittsburgh Sleep Quality Index (PSQI)
timeFrame: before the treatment and up to 12 weeks after completion of the treatment
measure: Effectiveness of EMG biofeedback therapy on pain symptoms in comparison to "standard" treatment measured by Numerical Rating Scale (NRS)
timeFrame: after treatment and up to 12 weeks later
measure: Effectiveness of EMG biofeedback therapy on pain symptoms in comparison to "standard" treatment measured by pressure pain threshold
timeFrame: after treatment and up to 12 weeks later
measure: Persistence in time of EMG biofeedback therapy effects on pain symptoms measured by Numerical Rating Scale (NRS)
timeFrame: after treatment and up to 12 weeks later
measure: Persistence in time of EMG biofeedback therapy effects on pain symptoms measured by pressure pain threshold
timeFrame: after treatment and up to 12 weeks later
Other outcomes:
Locations:
city: Wrocław
country: Poland
facility: Wroclaw Medical University
state: Dolny Śląsk
Study officials:
affiliation: Wroclaw Medical University
name: Mieszko Więckiewicz, D.M.D.Ph.D.
role: STUDY_CHAIR
References: