EFFECTİVENESS OF PULSED ULTRASOUND TREATMENT ON PATIENTS WITH BELL'S PALSY
Primary Purpose
Bell Palsy
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Therapeutic Pulsed Ultrasound
Sham Ultrasound
Sponsored by
About this trial
This is an interventional treatment trial for Bell Palsy focused on measuring Bell's palsy, facial paralysis, pulsed ultrasound
Eligibility Criteria
Inclusion Criteria:
- Aged 18-65 years
- Clinically diagnosed as Bell's palsy by an ear nose and throat specialist.
Exclusion Criteria:
- Central nervous system pathology
- Recurrent Bell's palsy
- Diabetes mellitus
Contraindications of ultrasound treatment
- Active infection
- Cancer
- Pregnancy
- Lactation
- Open wound around application area
Sites / Locations
- Fatih Sultan Mehmet Training and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Pulsed Ultrasound Group
Sham Group
Arm Description
Patients in pulsed ultrasound group received pulsed ultrasound treatment (frequency: 1000 kHz, intensity: 0.5w/cm2, on-off ratio: 1:2 ) 5-min daily session, 5 days per weeks, for a total of 15 sessions.
Control group received sham ultrasound with the same protocol.
Outcomes
Primary Outcome Measures
Sunnybrook Facial Grading System
Sunnybrook Facial Grading System is a scale used to assess facial function, and scores range from 0 (complete paralysis) to 100 (normal facial function). This scale provides a clinical score which combines a static and dynamic assessment of facial muscles with the degree of synkinesis.
Hause Brackman Facial Nerve Grading System
Hause Brackman Facial Nerve Grading System is based on a six-grade score ( I-VI) that offers a gross evaluation of facial motor function and also includes evaluation of sequelae.
Facial Disability Index
Facial Disability Index evaluates the disability of individuals with Bell's Palsy by a total of 10 questions which assess physical and social limitations.
Secondary Outcome Measures
Electrophysiologic Changes
Secondary outcome measures were changes of facial nerve latencies and amplitudes of compound muscle action potentials derived from the frontalis and orbicularis oris muscles.
Full Information
NCT ID
NCT04412733
First Posted
May 29, 2020
Last Updated
May 29, 2020
Sponsor
Fatih Sultan Mehmet Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04412733
Brief Title
EFFECTİVENESS OF PULSED ULTRASOUND TREATMENT ON PATIENTS WITH BELL'S PALSY
Official Title
EFFECTIVENESS OF PULSED ULTRASOUND TREATMENT ON PATIENT WITH BELL'S PALSY, A DOUBLE-BLIND, RANDOMİZED, PLACEBO-CONTROLLED TRIAL
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
March 20, 2020 (Actual)
Study Completion Date
March 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fatih Sultan Mehmet Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Bell's palsy (idiopathic facial palsy) is the most common peripheral lesion of the cranial nerves and the most common mono-neuropathy. Therapeutic ultrasound (US) is among the commonly used physical modalities for treating musculoskeletal disorders. The effects of US are due to alteration of cell membrane activity, vascular wall permeability and facilitation of tissue healing. The aim of this study is to investigate the effect of pulsed US treatment in patients with Bell's palsy when added to superficial heating, massage and exercise therapies.
Detailed Description
In this double -blind, randomized placebo-controlled trial, 32 patients (aged 18-65 years) diagnosed as idiopathic facial palsy with appropriate criteria were included. All patients were evaluated with motor nerve conduction studies and electromyography at 3-4 weeks after the onset of paralysis and 3 months after the treatment. Paralytic side frontalis and orbicularis oris muscles were used for electrophysiological analysis. Electrophysiological examinations were performed by an experienced electromyographer who was blind to the patient's treatments. Patients were separated into two groups as Group 1 (pulsed ultrasound therapy) and Group 2 (sham). Both groups were undergone to a conservative treatment program (20 min hot pack, massage 20 min and facial expression exercises) for 3 weeks, 5 days a week. In group 1 pulsed US treatment (frequency: 1000 kHz, intensity: 0.5w/cm2, on-off ratio: 1:2, duration 5 min) were applied to the paralyzed facial muscles. The patients in group 2 received exactly the same procedure as the treatment group, except that the power switch was off. All treatments were applied for 5 days a week for 3 weeks by the same 5-cm2 head US device (Enraf-Nonius Sonopuls 434) and the same physiotherapist. Patients were assessed at baseline, after last session, and 3 months after the treatment. Sunnybrook Facial Grading System, House Brackmann Facial Grading System and Facial Disability Index and electrophysiologic parameters were used for outcome evaluation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bell Palsy
Keywords
Bell's palsy, facial paralysis, pulsed ultrasound
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pulsed Ultrasound Group
Arm Type
Experimental
Arm Description
Patients in pulsed ultrasound group received pulsed ultrasound treatment (frequency: 1000 kHz, intensity: 0.5w/cm2, on-off ratio: 1:2 ) 5-min daily session, 5 days per weeks, for a total of 15 sessions.
Arm Title
Sham Group
Arm Type
Sham Comparator
Arm Description
Control group received sham ultrasound with the same protocol.
Intervention Type
Device
Intervention Name(s)
Therapeutic Pulsed Ultrasound
Intervention Description
Patients in pulsed ultrasound group received pulsed ultrasound treatment (frequency: 1000 kHz, intensity: 0.5w/cm2, on-off ratio: 1:2). Pulsed ultrasound treatment were applied with 5-cm2 head Enraf-Nonius Sonopuls 434 ultrasound device.
Intervention Type
Device
Intervention Name(s)
Sham Ultrasound
Intervention Description
Control group received sham ultrasound treatment
Primary Outcome Measure Information:
Title
Sunnybrook Facial Grading System
Description
Sunnybrook Facial Grading System is a scale used to assess facial function, and scores range from 0 (complete paralysis) to 100 (normal facial function). This scale provides a clinical score which combines a static and dynamic assessment of facial muscles with the degree of synkinesis.
Time Frame
3 months
Title
Hause Brackman Facial Nerve Grading System
Description
Hause Brackman Facial Nerve Grading System is based on a six-grade score ( I-VI) that offers a gross evaluation of facial motor function and also includes evaluation of sequelae.
Time Frame
3 months
Title
Facial Disability Index
Description
Facial Disability Index evaluates the disability of individuals with Bell's Palsy by a total of 10 questions which assess physical and social limitations.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Electrophysiologic Changes
Description
Secondary outcome measures were changes of facial nerve latencies and amplitudes of compound muscle action potentials derived from the frontalis and orbicularis oris muscles.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 18-65 years
Clinically diagnosed as Bell's palsy by an ear nose and throat specialist.
Exclusion Criteria:
Central nervous system pathology
Recurrent Bell's palsy
Diabetes mellitus
Contraindications of ultrasound treatment
Active infection
Cancer
Pregnancy
Lactation
Open wound around application area
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meryem Yilmaz Kaysin, MD
Organizational Affiliation
Fatih Sultan Mehmet Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fatih Sultan Mehmet Training and Research Hospital
City
Istanbul
State/Province
Ataşehir
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Patients were separated into two groups as Group 1 (pulsed ultrasound therapy) and Group 2 (sham). Both groups were undergone to a conservative treatment program (20 min hot pack, massage 20 min and facial expression exercises) for 3 weeks, 5 days a week. In group 1 pulsed US treatment (frequency: 1000 kHz, intensity: 0.5w/cm2, on-off ratio: 1:2, duration 5 min) were applied to the paralyzed facial muscles. The patients in group 2 received exactly the same procedure as the treatment group, except that the power switch was off. All treatments were applied for 5 days a week for 3 weeks by the same 5-cm2 head US device (Enraf-Nonius Sonopuls 434) and the same physiotherapist. Patients were assessed at baseline, after last session, and 3 months after the treatment. Sunnybrook Facial Grading System, House Brackmann Facial Grading System and Facial Disability Index and electrophysiologic parameters were used for outcome evaluation.
Learn more about this trial
EFFECTİVENESS OF PULSED ULTRASOUND TREATMENT ON PATIENTS WITH BELL'S PALSY
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