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This study aims to investigate the effect of low energy extracorporeal shock wave therapy on patients with Bell's palsy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low energy extracorporeal shockwave therapy + Selective physical therapy program | Experimental | This group will receive low energy extracorporeal shockwave therapy in addition to a selective physical therapy program (therapeutic exercise plus massage), 2 sessions per week for 6 weeks. |
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| Selective physical therapy program | Active Comparator | This group will receive a selective physical therapy program (therapeutic exercise plus massage), 2 sessions per week for 6 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dina Hamdy Mahmoud Abd el Aziz, B.Sc | Contact | +20 10 31190767 | dinamahmoud11289@gmail.com | |
| Rasha Mohamed El Rewiny, PhD | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Rasha Mohamed El Rewiny, PhD | Ass. Professor, Cairo University | Study Chair |
| Ebtsam Mohamed Fahmy, PhD | Professor, Cairo University | Study Director |
| Mohamed Helayel Marzouk Helayel, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Physical Therapy, Cairo University | Giza | 12511 | Egypt |
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| ID | Term |
|---|---|
| D020330 | Bell Palsy |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| 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. |
|
| 6 weeks |
| Lecturer, Cairo University |
| Study Director |
| D009059 |
| Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D005155 | Facial Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |