Clinical trial NCT04412733: 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
Overall status: COMPLETED
Phase: NA
Conditions: Bell Palsy
Keywords: Bell's palsy
facial paralysis
pulsed ultrasound
Lead sponsor: Fatih Sultan Mehmet Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Sunnybrook Facial Grading System
timeFrame: 3 months
measure: Hause Brackman Facial Nerve Grading System
timeFrame: 3 months
measure: Facial Disability Index
timeFrame: 3 months
Secondary outcomes:
measure: Electrophysiologic Changes
timeFrame: 3 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Fatih Sultan Mehmet Training and Research Hospital
state: Ataşehir
Study officials:
affiliation: Fatih Sultan Mehmet Training and Research Hospital
name: Meryem Yilmaz Kaysin, MD
role: PRINCIPAL_INVESTIGATOR
References: