Bell PalsyNCT07661134
Effect of Low Energy Extracorporeal Shockwave on Patients With Bell's Palsy
A study testing Low energy extracorporeal shockwave therapy and Selective physical therapy program in people with Bell Palsy, run by Cairo University at 1 site in Egypt.
Trial summary
This study aims to investigate the effect of low energy extracorporeal shock wave therapy on patients with Bell's palsy. Read more about this study
- Who is it for?
- Ages 45 to 55 years
- Conditions the study is for
- Bell Palsy
- What is being tested?
- Low energy extracorporeal shockwave therapy and Selective physical therapy program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jun 2026to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rasha Mohamed El Rewiny, PhD contact
Egypt1 site
Faculty of Physical Therapy, Cairo University
Giza, 12511
Dina Hamdy Mahmoud Abd el Aziz, B.Sc, +20 10 31190767, dinamahmoud11289@gmail.com
Rasha Mohamed El Rewiny, PhD
About this study
This study aims to investigate the effect of low energy extracorporeal shock wave therapy on patients with Bell's palsy.
Read the detailed description
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.
- Conditions
- Bell Palsy
- Being tested
- Low energy extracorporeal shockwave therapy, Selective physical therapy program
- Medical subject headings
- Bell Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low energy extracorporeal shockwave therapyDevice
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 programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Low energy extracorporeal shockwave therapy; Other: Selective physical therapy program |
| 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. Receives: Other: Selective physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (1)
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start25 Jun 2026 (estimated)
- Primary completion25 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bell PalsyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Hamdy Mahmoud Abd el Aziz, Cairo University
- Investigators
- Rasha Mohamed El Rewiny, PhD, Study chair, Ass. Professor, Cairo UniversityEbtsam Mohamed Fahmy, PhD, Study director, Professor, Cairo UniversityMohamed Helayel Marzouk Helayel, PhD, Study director, Lecturer, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07661134
- Sponsor's protocol ID
- P.T.REC/012/005544
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low Energy Extracorporeal Shockwave on Patients With Bell's Palsy
- ClinicalTrials.gov ID
- NCT07661134
- Acronym / sponsor ID
- P.T.REC/012/005544
- Conditions
- Bell Palsy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Jun 2026 (estimated)
- Primary completion
- 25 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate the effect of low energy extracorporeal shock wave therapy on patients with Bell's palsy.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low energy extracorporeal shockwave therapy + Selective physical therapy program | Experimental | Device: Low energy extracorporeal shockwave therapy, Other: Selective physical therapy programThis 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. |
| Selective physical therapy program | Active comparator | Other: Selective physical therapy programThis group will receive a selective physical therapy program (therapeutic exercise plus massage), 2 sessions per week for 6 weeks. |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low energy extracorporeal shockwave therapyParticipants 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. | Device | Low energy extracorporeal shockwave therapy + Selective physical therapy program |
| Selective physical therapy programParticipants 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. | Other | Low energy extracorporeal shockwave therapy + Selective physical therapy program, Selective physical therapy program |
Primary outcome
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.
1 secondary outcome
House-Brackmann Facial Nerve Grading Scale
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
Related trials for Bell Palsy
Not yet recruiting
Deep-plane Facelift As A Staged Adjunct To Facial Reanimation : Functional And Aesthetic Outcomes in Comparison to Facial Reanimation Alone
Facial Palsy
RecruitingPhase 3
Steroids for Facial Nerve Function Protection in Post-surgical Vestibular Schwannoma Patients
Vestibular Schwannoma, Facial Nerve Paralysis
Recruiting
Eye-Tracking FP "A Pilot Study of the Quantitative Evaluation of the Attention Paid to Faces With Facial Palsy by the Eye-tracking Technology.
Eye-tracking, Facial Palsy
Not yet recruiting
Mindfulness in Nonflaccid Facial Paralysis
Facial Paralysis
Recruiting
Treatment for "Asymmetric Crying Facies"
Hemifacial Microsomia, Facial Nerve Paralysis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rasha Mohamed El Rewiny, PhD contact
Rasha Mohamed El Rewiny, PhD study chair
Ass. Professor, Cairo University
Ebtsam Mohamed Fahmy, PhD study director
Professor, Cairo University
Mohamed Helayel Marzouk Helayel, PhD study director
Lecturer, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low energy extracorporeal shockwave therapy and Selective physical therapy program in people with Bell Palsy, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dina Hamdy Mahmoud Abd el Aziz, B.Sc (+20 10 31190767, dinamahmoud11289@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CMAP Amplitude Asymmetry Percentage (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.