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Trial record 3 of 5 for:    Recruiting, Not yet recruiting, Available Studies | "Sleep Bruxism"

Evaluation of Biofeedback Therapy Efficiency in Sleep Bruxism and Masticatory Muscles Pain Management

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ClinicalTrials.gov Identifier: NCT03421028
Recruitment Status : Not yet recruiting
First Posted : February 2, 2018
Last Update Posted : February 2, 2018
Sponsor:
Information provided by (Responsible Party):
Wojciech Florjański, Wroclaw Medical University

Brief Summary:

This study evaluates beneficial effects of biofeedback therapy in reducing pain and increased tension of masticatory muscles occurring in patients with sleep bruxism.

During the study two functions of Biofeedback will be used: Functional Electro Stimulation (FES) delivering stimulation to relax masseter muscles and Electromyography Biofeedback (EMG-Biofeedback)- assisted training lowering the masseter muscle tension. The experimental group consists of adult subjects with sleep bruxism and masticatory muscles pain will be join to 8 meetings of FES and EMG-Biofeedback - assisted training and than compared to the control group consists of randomly enrolled adult subjects .


Condition or disease Intervention/treatment Phase
Sleep Bruxism, Adult Muscle Pain Feedback, Psychological Device: Functional Electrical Stimulation Biofeedback Device: Electromyography Biofeedback Not Applicable

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 sleep bruxism and intensity of sleep bruxism episodes.

  2. Patients:

    1. Control group - randomly selected healthy adult patients. The Group will include between 20-30 adults.
    2. Experimental group - patients with diagnosed sleep bruxism and masticatory muscle pain. The group will include approximately 30 adults.
  3. Methods:

All patients taking part in the study will be examined according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) to find the masticatory muscles disorders.

Based on the guidelines of the American Academy of Sleep Medicine (ICD 10- CM), a preliminary diagnosis of sleep bruxism will be made. Bruxoff device will be used to performed objective confirmation of the initial diagnosis and severity of bruxism - number of bruxism episodes per hour of sleep (Bruxism Episodes Index). Bruxoff is a sleep monitor which measures the activity of masticatory muscles and rhythm of the patient's heart during sleep.

Intensity of pain in the masticatory muscle muscles will be define using the Numerical Rating Scale (NRS) and the Graded Chronic Pain Scale. Sleep quality will be assessed with Pittsburgh Sleep Quality Index (PSQI) and insomnia symptoms with Athens Insomnia Scale (AIS).

People participating in the study (experimental group) will undergo a cycle of FES delivering stimulation to relax masseter muscles and EMG-Biofeedback- assisted training decreasing the masseter muscle tension (1 cycle equals 8 meetings, 1 meeting per week).

In the next stage, the bruxism episodes index will be re-evaluated using the Bruxoff device and pain intensity with the NRS scale and the Graded Chronic Pain Scale. Also sleep quality and insomnia symptoms will be re-assessed using Pittsburgh Sleep Quality Index (PSQI) and Athens Insomnia Scale (AIS).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Evaluation of EMG-biofeedback and Functional Electrical Stimulation (FES) Therapy Efficiency in Management of Sleep Bruxism and Masticatory Muscles Pain
Estimated Study Start Date : February 1, 2018
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
No Intervention: Control group
Patients with no masticatory muscle pain and no sleep bruxism
Experimental: Experimental group (FES and EMG-biofeedback)
Patients diagnosed with masticatory muscle pain and sleep bruxism
Device: Functional Electrical Stimulation Biofeedback
Functional Electrical Stimulation (FES) is a method in which the device is delivering small electrical pulses through electrodes situated on the surface of the skin to exert specific effect. In case of this study to relax masseter muscles.
Other Name: FES Biofeedback

Device: 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 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)
Other Name: EMG-Biofeedback




Primary Outcome Measures :
  1. Change in intensity of sleep bruxism after biofeedback therapy [ Time Frame: before the treatment and up to 10 weeks later ]
    This effect will be assessed by comparing Bruxism Episodes Index (BEI) pre- and post- biofeedback therapy by using Bruxoff device.


Secondary Outcome Measures :
  1. Change in masticatory muscles pain assessed by Numerical Rating Scale (NRS ) after biofeedback therapy [ Time Frame: before the treatment and up to 10 weeks later ]
    This effect will be assessed by comparing Numerical Rating Scale (NRS) questionnaires pre- and post- biofeedback therapy. The The NRS is a numeric scale in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line. Higher values post therapy indicate worse outcome and lower better outcome.

  2. Change in masticatory muscles pain and disability assessed by Graded Chronic Pain Scale [ Time Frame: before the treatment and up to 10 weeks later ]
    This effect will be assessed by comparing the Graded Chronic Pain Scale (GCPS) questionnaires pre- and post- biofeedback therapy. GCPS is a scale assessing pain and disability related to Temporomandibular Disorders in prior 6 months. Subscale scores for pain intensity and disability are combined to calculate a chronic pain grade that enables classification of chronic pain patients into 5 hierarchical categories: grades 0 (no pain) to IV (high disability-severely limiting). Higher values post therapy indicate worse outcome and lower better outcome.

  3. Change in sleep quality assessed by Pittsburgh Sleep Quality Index questionnaire. [ Time Frame: before the treatment and up to 10 weeks later ]
    This effect will be assessed by comparing Pittsburgh Sleep Quality Index (PSQI) questionnaires pre- and post- biofeedback therapy. PSQI contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if on is available). 19 self-rated items are combined to form seven "componet" scores, each of whih has a range of 0-3 points. In all cases, a score of "0" indicates no difficulty, while a score of "3" indicates severe difficulty. The scores are then added to yield one "global" score, with a range of 0-21 points, "0" indicating no difficulty and "21" indicating severe difficulties in all areas. Higher values post therapy indicate worse outcome and lower better outcome.

  4. Change in sleep disorders assessed by Athens Insomnia Scale questionnaire. [ Time Frame: before the treatment and up to 10 weeks later ]
    This effect will be assessed by comparing Athens Insomnia Scale (AIS) questionnaires pre- and post- biofeedback therapy. AIS consist of eight questions,amongst which first five factors are related to nocturnal sleep and last three factors are related to daytime dysfunction.These are rated on a 0-3 scale, where "0" means no problem or normal and "3" means did not sleep at all or very decreased. Finally scores from each question are summed giving total score. A cut-off score of ≥6 on the AIS is used to establish the diagnosis of insomnia. Higher values post therapy indicate worse outcome and lower better outcome.

  5. Relation between sleep bruxism and masticatory muscles pain assessed by Graded Chronic Pain Scale [ Time Frame: up to 1 year ]
    Each participant (from the experimental group and the control group) will fill in Graded Chronic Pain Scale questionnaire before the biofeedback therapy. The results between two groups will be compared to verify if there is a statistically significant difference.

  6. Relation between sleep bruxism and masticatory muscles pain assessed by Numerical Rating Scale (NRS) [ Time Frame: up to 1 year ]
    Each participant (from the experimental group and the control group) will fill in Numerical Rating Scale (NRS) questionnaire before the biofeedback therapy. The results between two groups will be compared to verify if there is a statistically significant difference.

  7. Relation between sleep bruxism and sleep quality assessed by Pittsburgh Sleep Quality Index questionnaire. [ Time Frame: up to 1 year ]
    Each participant (from the experimental group and the control group) will fill in Pittsburgh Sleep Quality Index questionnaire before the biofeedback therapy. The results between two groups will be compared to verify if there is a statistically significant difference.

  8. Relation between sleep bruxism and sleep disorders assessed by Athens insomnia scale questionnaire. [ Time Frame: up to 1 year ]
    Each participant (from the experimental group and the control group) will fill in Athens insomnia scale questionnaire before the biofeedback therapy. The results between two groups will be compared to verify if there is a statistically significant difference.

  9. Relation between masticatory muscles pain and sleep quality assessed by Pittsburgh Sleep Quality Index questionnaire. [ Time Frame: up to 1 year ]
    Each participant (from the experimental group and the control group) will fill in Pittsburgh Sleep Quality Index questionnaire before the biofeedback therapy. The results between two groups will be compared to verify if there is a statistically significant difference.

  10. Relation between masticatory muscles pain and sleep disorders assessed by Athens insomnia scale questionnaire. [ Time Frame: up to 1 year ]
    Each participant (from the experimental group and the control group) will fill in Athens insomnia scale questionnaire before the biofeedback therapy. The results between two groups will be compared to verify if there is a statistically significant difference.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • diagnosed sleep bruxism
  • presence of masticatory muscles pain
  • 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
  • taking drugs that affect muscle function
  • edentulism
  • confirmed alcoholism
  • drug addiction

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03421028


Contacts
Contact: Wojciech Florjański, M.D., D.M.D. +48783602042 wojciech.florjanski@umed.wroc.pl
Contact: Andrzej Małysa, D.M.D. +48669590058 andrzejmalysa@o2.pl

Locations
Poland
Wroclaw Medical University Enrolling by invitation
Wrocław, Dolny Śląsk, Poland
Sponsors and Collaborators
Wroclaw Medical University
Investigators
Study Chair: Mieszko Więckiewicz, D.M.D., Ph.D. Wroclaw Medical University

Responsible Party: Wojciech Florjański, Principal Investigator, Wroclaw Medical University
ClinicalTrials.gov Identifier: NCT03421028     History of Changes
Other Study ID Numbers: WMU2/2017
First Posted: February 2, 2018    Key Record Dates
Last Update Posted: February 2, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Sleep Bruxism
Bruxism
Myalgia
Tooth Diseases
Stomatognathic Diseases
Muscular Diseases
Musculoskeletal Diseases
Musculoskeletal Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Parasomnias
Sleep Wake Disorders
Mental Disorders