Evaluation of Biofeedback Therapy Efficiency in Masticatory Muscles Pain Management

NCT03421028 | Unknown

• 1 other identifier: WMU2/2017
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• The effect of EMG biofeedback therapy on pain symptoms measured by Numerical Rating Scale (NRS) in Experimental group 1

  This effect will be assessed by comparing Numerical Rating Scale (NRS) pre- and post- biofeedback therapy. A numerical rating scale (NRS) requires the patient to rate their pain on a scale 0-10, where 0 is no pain and 10 is the worst pain imaginable

  before the treatment, after 4 weeks of training

• The effect of EMG biofeedback therapy on pain symptoms measured by Numerical Rating Scale (NRS) in Experimental group 2

  This effect will be assessed by comparing Numerical Rating Scale (NRS) pre- and post- biofeedback therapy. A numerical rating scale (NRS) requires the patient to rate their pain on a scale 0-10, where 0 is no pain and 10 is the worst pain imaginable

  before the treatment, after 8 weeks of training

• The effect of EMG biofeedback therapy on pain symptoms measured by pressure pain threshold in Experimental group 1

  This effect will be assessed by comparing pressure pain threshold pre- and post- biofeedback therapy. Pressure pain threshold will be measured with dolorimeter.

  before the treatment, after 4 weeks of training

• The effect of EMG biofeedback therapy on pain symptoms measured by pressure pain threshold in Experimental group 2

  This effect will be assessed by comparing pressure pain threshold pre- and post- biofeedback therapy. Pressure pain threshold will be measured with dolorimeter.

  before the treatment, after 8 weeks of training

Secondary Outcomes (9)

• Effect of EMG biofeedback therapy on psychological parameters and its persistence in time measured by Beck Anxiety Inventory (BAI).

  before the treatment and up to 12 weeks after completion of the treatment

• Effect of EMG biofeedback therapy on psychological parameters and its persistence in time measured by Patient Health Questionnaire-9 (PHQ-9)

  before the treatment and up to 12 weeks after completion of the treatment

• Effect of EMG biofeedback therapy on psychological parameters and its persistence in time measured by Perceived Stress Scale-10 (PSS-10)

  before the treatment and up to 12 weeks after completion of the treatment

• Effect of EMG biofeedback therapy on psychological parameters and its persistence in time measured by Somatic Symptom Scale-8 (SSS-8).

  before the treatment and up to 12 weeks after completion of the treatment

• Effect of EMG biofeedback therapy on sleep quality and its persistence in time measured by Pittsburgh Sleep Quality Index (PSQI)

  before the treatment and up to 12 weeks after completion of the treatment

Study Arms (3)

Control group

ACTIVE COMPARATOR

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

Other: Classic treatment for myogenous TMD

Experimental group 1

EXPERIMENTAL

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

Device: Electromyography Biofeedback

Experimental group 2

EXPERIMENTAL

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

Device: Electromyography Biofeedback

Interventions

Electromyography Biofeedback DEVICE

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)

Also known as: EMG-Biofeedback

Experimental group 1; Experimental group 2

Classic treatment for myogenous TMD OTHER

Combination of physiotherapy (manual therapy), stabilization occlusal splint usage and counseling

Control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wroclaw Medical University: lead

Study Sites (1)

Wroclaw Medical University

Wroclaw, Dolny Śląsk, Poland

Location

MeSH Terms

Conditions

Myalgia; Craniomandibular Disorders; Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mandibular Diseases; Jaw Diseases; Stomatognathic Diseases; Joint Diseases

Study Officials

• Mieszko Więckiewicz, D.M.D.Ph.D.

  Wroclaw Medical University

  STUDY CHAIR

Central Study Contacts

Wojciech Florjański, D.M.D.P.H.D.

CONTACT

+48783602042; wojciech.florjanski@umed.wroc.pl

Mieszko Więckiewicz, D.M.D.Ph.D.

CONTACT

m.wieckiewicz@onet.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 2, 2018
• First Posted: February 5, 2018
• Study Start: January 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: December 31, 2024
• Last Updated: July 7, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)