- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07661134
Effect of Low Energy Extracorporeal Shockwave on Patients With Bell's Palsy
16. juni 2026 opdateret af: Dina Hamdy Mahmoud Abd el Aziz, Cairo University
This study aims to investigate the effect of low energy extracorporeal shock wave therapy on patients with Bell's palsy.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
42
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Dina Hamdy Mahmoud Abd el Aziz, B.Sc
- Telefonnummer: +20 10 31190767
- E-mail: dinamahmoud11289@gmail.com
Undersøgelse Kontakt Backup
- Navn: Rasha Mohamed El Rewiny, PhD
Studiesteder
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Giza, Egypten, 12511
- Faculty of Physical Therapy, Cairo University
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Kontakt:
- Dina Hamdy Mahmoud Abd el Aziz, B.Sc
- Telefonnummer: +20 10 31190767
- E-mail: dinamahmoud11289@gmail.com
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Kontakt:
- Rasha Mohamed El Rewiny, PhD
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Low energy extracorporeal shockwave therapy + Selective physical therapy program
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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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.
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.
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Aktiv komparator: Selective physical therapy program
This group will receive a selective physical therapy program (therapeutic exercise plus massage), 2 sessions per week for 6 weeks.
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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CMAP Amplitude Asymmetry Percentage
Tidsramme: 6 weeks
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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.
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6 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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House-Brackmann Facial Nerve Grading Scale
Tidsramme: 6 weeks
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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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6 weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studiestol: Rasha Mohamed El Rewiny, PhD, Ass. Professor, Cairo University
- Studieleder: Ebtsam Mohamed Fahmy, PhD, Professor, Cairo University
- Studieleder: Mohamed Helayel Marzouk Helayel, PhD, Lecturer, Cairo University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
25. juni 2026
Primær færdiggørelse (Anslået)
25. september 2026
Studieafslutning (Anslået)
30. september 2026
Datoer for studieregistrering
Først indsendt
16. juni 2026
Først indsendt, der opfyldte QC-kriterier
16. juni 2026
Først opslået (Faktiske)
22. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
22. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- P.T.REC/012/005544
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