EFFECTİVENESS OF PULSED ULTRASOUND TREATMENT ON PATIENTS WITH BELL'S PALSY

NCT ID: NCT04412733

Last Updated: 2020-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2020-03-20

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.

Conditions

Bell Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Pulsed Ultrasound Group

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.

Group Type: EXPERIMENTAL

Therapeutic Pulsed Ultrasound

Intervention Type: DEVICE

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.

Sham Group

Control group received sham ultrasound with the same protocol.

Group Type: SHAM_COMPARATOR

Sham Ultrasound

Intervention Type: DEVICE

Control group received sham ultrasound treatment

Interventions

Therapeutic Pulsed Ultrasound

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

Sham Ultrasound

Control group received sham ultrasound treatment

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fatih Sultan Mehmet Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Meryem Yilmaz Kaysin, MD

Role: PRINCIPAL_INVESTIGATOR

Fatih Sultan Mehmet Training and Research Hospital

Locations

Fatih Sultan Mehmet Training and Research Hospital

Istanbul, Ataşehir, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

meryemkaysin

Identifier Type: -

Identifier Source: org_study_id