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NCT Number: NCT07661134

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

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

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Key information

Conditions

Bell Palsy Cranial Nerve Diseases DNA Virus Infections Facial Nerve Diseases Herpesviridae Infections Infections Mouth Diseases Nervous System Diseases Stomatognathic Diseases Virus Diseases

Age range

45 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physical Therapy, Cairo University

Giza, 12511, Egypt

Location contact

Dina Hamdy Mahmoud Abd el Aziz, B.Sc

CONTACT

[email protected]

+20 10 31190767

Rasha Mohamed El Rewiny, PhD

CONTACT

About this study

Bell's palsy may range in severity from near-normal facial function to crippling facial disfigurement. It severity has been recognized to influence patient perceived quality of life to varying degrees. It yields myriad deficits affecting form and function. It can be a devastating and disfiguring condition, leading to psychological difficulties and restrictions of facial expressions, and may have a dramatic impact on interpersonal relationships. Facial nerve paralysis (FNP) often causes decreased quality of life and may lead to significant facial dysfunction. It is a health issue causing concern and has an extremely negative effect on both patients and their families. Main goals of treatment are to speed recovery, to make recovery more complete, to prevent corneal complications and other sequelae, and to inhibit viral replication. Psychological support is also essential. Patients require regular follow ups. Patients with Bell's palsy should be referred to a specialist and treatment should start as soon after onset as possible. In recent studies on peripheral nerves injuries, Low energy extracorporeal shock wave is a new tool for management. Extracorporeal shock wave therapy not only used in (urinary stone lithotripsy treatment, in the musculoskeletal field (lateral and medial epicondylitis, plantar fasciitis, calcific tendinitis of the shoulder, and bony union after fracture), muscle rigidity, muscular pain, knee degenerative arthritis, and lymphedema), but also used in regeneration of peripheral nerves. It causes molecular and biological changes, in addition to mechanical and physical stimulation. So in this study, we aim to determine the effect of low energy extracorporeal shock wave on Bell's palsy patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Body mass index (18.5-29.9kg/m2).
  • It includes the patient in the chronic stage.
  • All patients are assessed by NCS and other functional scales.
  • All patients will be referred by neurological consultants.
  • All patients have controlled diabetes mellitus and are medically stable.

Exclusion criteria

  • Patients with a history of facial paralysis post-stroke.
  • Patients with unstable medical conditions.
  • Patients with psychiatric disorders.
  • Patients with other neurological diseases.
  • Patients with other causes for Bell's palsy.
  • Patients with diabetic diseases.

Treatment and study plan

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

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.

Primary outcomes

  1. CMAP Amplitude Asymmetry Percentage

    Time frame: 6 weeks

    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.

Secondary outcomes

  1. House-Brackmann Facial Nerve Grading Scale

    Time frame: 6 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dina Hamdy Mahmoud Abd el Aziz, B.Sc

CONTACT

[email protected]

+20 10 31190767

Rasha Mohamed El Rewiny, PhD

CONTACT

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 22, 2026
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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