Effect of Low Energy Extracorporeal Shockwave on Patients With Bell's Palsy

ConditionBell Palsy

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age45-55

SponsorCairo University

About this trial

This study aims to investigate the effect of low energy extracorporeal shock wave therapy on patients with Bell's palsy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with unilateral Bell's palsy (only lower motor neuron lesion).

Patient with idiopathic or viral infection, Bell's palsy.

The age ranged from 45 to 55 years old.

Both males and females are included.

Disqualifiers

Patients with a history of facial paralysis post-stroke.

Patients with unstable medical conditions.

Patients with psychiatric disorders.

Patients with other neurological diseases.

Trial design

Design model

Parallel

Treatments tested in this trial

Low energy extracorporeal shockwave therapy
Device
Participants allocated to the experimental group will receive low-energy extracorporeal shockwave therapy (LE-ESWT) using a shockwave device set at a frequency of 10 Hz, energy intensity of 2.5, and a total dose of 2500 shockwaves per session. The treatment will be delivered to two sites along the facial nerve pathway, including the stylomastoid foramen (500 shockwaves) and a point located 1 cm anterior to the ear (2000 shockwaves). Each session will be administered for approximately 15 minutes throughout the intervention period.
Selective physical therapy program
Other intervention
Participants will receive a standardized physical therapy program including neuromuscular reeducation and massage therapy. Facial exercises will be performed in front of a mirror to improve symmetry and facial muscle control, with therapist assistance provided as needed. Massage therapy will be applied to the neck, scalp, and facial regions. Each treatment session will last approximately 30 minutes.

Treatment groups

42 Participants

are divided into 2 treatment groups

Group A: Low energy extracorporeal shockwave therapy + Selective physical therapy programExperimental treatment 2 interventions

Group B: Selective physical therapy programActive comparator 1 intervention

Trial outcomes

Primary outcomes

CMAP Amplitude Asymmetry Percentage

Facial nerve function will be assessed using nerve conduction studies (NCS). Compound muscle action potential (CMAP) amplitudes will be recorded bilaterally by stimulating the facial nerve anterior to the mastoid process and recording responses from the nasalis muscle. The percentage of CMAP amplitude asymmetry between the affected and unaffected sides will be calculated as \[(CMAP amplitude affected side - CMAP amplitude unaffected side)/CMAP amplitude unaffected side\] × 100. Lower asymmetry values will indicate improved facial nerve conduction and recovery. Assessments will be performed at baseline and after completion of the treatment program.

Time frame

6 weeks

Secondary outcomes

House-Brackmann Facial Nerve Grading Scale

Facial function will be evaluated using the House-Brackmann (HB) Facial Nerve Grading Scale, a validated six-grade clinical assessment tool ranging from Grade I (normal facial function) to Grade VI (total facial paralysis). The scale assesses facial symmetry at rest and voluntary facial movements, providing an overall measure of facial nerve dysfunction severity. Lower HB grades will indicate better facial function and recovery. Assessments will be conducted at baseline and following completion of the treatment program.

Time frame

6 weeks

Sponsors and contacts

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Cairo University

Lead sponsor

Source ClinicalTrials.gov

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