Bell's PalsyNCT07266636
Effects of Photobiomodulation and Electrical Stimulation Among Bell's Palsy Patients
A study testing Photobiomodulation alongwith facial exercise and Electrical Stimulation alongwith facial exercise in people with Bell's Palsy, run by Lahore University of Biological and Applied Sciences.
Trial summary
Despite promising evidence supporting both photobiomodulation (PBM) and electrical stimulation (ES) in Bell's palsy rehabilitation, key gaps remain in the literature. Few studies have directly compared these modalities under standardized conditions, especially while keeping facial exercises constant across groups. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Bell's Palsy
- What is being tested?
- Photobiomodulation alongwith facial exercise and Electrical Stimulation alongwith facial exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 25 Nov 2025to 25 May 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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants diagnosed with idiopathic Bell's palsy by the Physicians, moderate to severe facial muscle weakness i.e. grade III-VI on the House-Brackmann scale and duration of the condition less than 2 weeks are the inclusion criteria Exclusion Criteria
- Participants with a middle ear infection, parotid gland tumor, malignant otitis externa, tumors in the base of the lateral skull, upper motor neuron facial palsy, segmental muscle weakness, recurrent episodes of facial paralysis, polyneuropathies and Ramsay Hunt Syndrome will be excluded from the study.
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparative Effect of Photobiomodulation and Electrical Stimulation on Facial Disability Among Bell's Palsy Patients
Despite promising evidence supporting both photobiomodulation (PBM) and electrical stimulation (ES) in Bell's palsy rehabilitation, key gaps remain in the literature. Few studies have directly compared these modalities under standardized conditions, especially while keeping facial exercises constant across groups. Inconsistent treatment parameters such as variations in PBM wavelength or ES intensity limit the comparability and replication of existing findings. Additionally, many studies rely on subjective outcome measures and lack structured timelines for assessing facial symmetry, neuromuscular coordination, or long-term recovery, including complications like synkinesis. These limitations highlight the need for a well-controlled comparative study to determine the more effective modality when paired with consistent facial rehabilitation exercises.
Read the detailed description
Bell's palsy is the most common form of lower motor neuron facial paralysis, accounting for approximately 60-75% of such cases. Although the exact cause remains unknown, it is often linked to viral infections that trigger inflammation of the facial nerve, leading to localized swelling, loss of myelin sheath, and reduced blood flow. Several factors have been identified that may increase susceptibility to the condition, including elevated blood glucose levels, poorly managed hypertension, severe pre-eclampsia, migraines, and exposure to radiation. Patients experience either partial or complete facial weakness, often accompanied by numbness, discomfort, sensitivity to sound, and changes in taste. Bell's palsy is primarily diagnosed through clinical assessment, with other potential causes being ruled out.
Among the various rehabilitative strategies, photobiomodulation (PBM) and electrical stimulation (ES) have gained significant attention. Both are non-invasive therapeutic modalities used to stimulate nerve regeneration, reduce inflammation, and promote muscle function. However, comparative studies evaluating their effectiveness in treating facial disability due to Bell's palsy remain limited. This study, therefore, aims to investigate the comparative effects of PBM and ES on facial disability in patients suffering from Bell's palsy, helping clinicians make evidence-informed decisions for optimal patient outcomes.
Physiotherapy plays a crucial role in Bell's palsy rehabilitation by targeting neuromuscular facilitation, enhancing synaptic activity, and restoring functional facial expressions. Photobiomodulation therapy, previously referred to as low-level laser therapy (LLLT), employs low-intensity lasers or light-emitting diodes (LEDs) to deliver light energy into tissues. This energy is absorbed by chromophores in cells, especially cytochrome c oxidase, triggering a cascade of biochemical events that stimulate ATP production, modulate reactive oxygen species (ROS), and reduce inflammation. These effects create a favorable environment for nerve regeneration and tissue healing.
Electrical stimulation involves applying controlled electrical currents through the skin to elicit muscle contractions. By stimulating the facial nerve or its motor endplates, ES is thought to maintain muscle tone, prevent atrophy, and potentially re-educate facial muscles through repetitive activation. Different protocols involve varying frequencies and waveforms, with surface electrodes most commonly used in clinical practice. The theoretical underpinning of both PBM and ES lies in the concept of neuroplasticity and tissue responsiveness to bioelectrical and biochemical signals. However, the optimal modality, timing, and dosage for facial nerve rehabilitation remain areas of ongoing research and debate, necessitating further empirical investigation.
- Conditions
- Bell's Palsy
- Being tested
- Photobiomodulation alongwith facial exercise, Electrical Stimulation alongwith facial exercise
- Keywords
- Photobiomodulation, Electrical Muscle Stimulation, Facial Exercises
- Medical subject headings
- Bell Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photobiomodulation alongwith facial exerciseRadiation
The intervention phase will last for 5-6 weeks, with participants receiving treatment 4-5 times per week, each session lasting 30-40 minutes, under therapist supervision.
PBM therapy will be administered using a low-level laser therapy (LLLT) device, with appropriate settings (e.g., wavelength, energy density, and duration). Each session will focus on treating the affected facial regions.
Facial Exercise will include manual therapy aimed at improving facial muscle tone, mobility, and circulation, customized for Bell's Palsy.
Electrical Stimulation alongwith facial exerciseOther
The intervention phase will last for 5-6 weeks, with participants receiving treatment 4-5 times per week, each session lasting 30-40 minutes, under therapist supervision.
EMS will be applied to the affected facial muscles using appropriate device settings. The therapy will focus on stimulating motor function and improving muscle tone.
Facial Exercise will be performed as described above in Group 1 to aid in relaxation and muscle tone restoration.
| Study group | Role | What they receive |
|---|---|---|
| Photobiomodulation along with facial exercises | Experimental | Group A will receive Photobiomodulation therapy alongwith facial exercises. The intervention phase will last for 5-6 weeks, with participants receiving treatment 4-5 times per week, each session lasting 30-40 minutes, under therapist supervision. Receives: Radiation: Photobiomodulation alongwith facial exercise |
| Electrical Muscle Stimulation alongwith facial exercises | Active comparator | Group B will receive Electrical Muscle Stimulation therapy alongwith facial exercises. The intervention phase will last for 5-6 weeks, with participants receiving treatment 4-5 times per week, each session lasting 30-40 minutes, under therapist supervision. Group A Receives: Other: Electrical Stimulation alongwith facial exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
House-Brackmann Facial Nerve Grading System
The HB scale categorizes facial nerve function into six grades, ranging from Grade I (normal function) to Grade VI (complete paralysis), based on assessments of symmetry at rest, degree of voluntary movement, and presence of synkinesis. It is widely used to assess the severity of facial palsy, monitor recovery after surgery or treatment, and track the progress of rehabilitation. The grading considers both resting facial appearance and movement during actions like raising the eyebrow and smiling
Measured: Baseline After 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start25 Nov 2025 (estimated)
- Primary completion25 May 2026 (estimated)
- Study completion25 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Bell's PalsyStudies of the same condition, open and under way.
- 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
- Model description
- Group A: The participants will recieve Photobiomodulation therapy alongwith facial exercises Group B: The participants will receive Electrical Muscle Stimulation alongwith facial exercises
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lahore University of Biological and Applied Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07266636
- Sponsor's protocol ID
- UBAS/ERB/FoRS/25/037 Kashaf
- Status last verified
- Nov 2025
- First submitted
- 24 Nov 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Glass GE. Photobiomodulation: The Clinical Applications of Low-Level Light Therapy. Aesthet Surg J. 2021 May 18;41(6):723-738. doi: 10.1093/asj/sjab025.
PubMed 33471046Kim MH, Park SY. Population-based study and a scoping review for the epidemiology and seasonality in and effect of weather on Bell's palsy. Sci Rep. 2021 Aug 20;11(1):16941. doi: 10.1038/s41598-021-96422-4.
PubMed 34417505Rasooly D, Ioannidis JPA, Khoury MJ, Patel CJ. Family History-Wide Association Study to Identify Clinical and Environmental Risk Factors for Common Chronic Diseases. Am J Epidemiol. 2019 Aug 1;188(8):1563-1568. doi: 10.1093/aje/kwz125.
PubMed 31172187Singh A, Deshmukh P. Bell's Palsy: A Review. Cureus. 2022 Oct 11;14(10):e30186. doi: 10.7759/cureus.30186. eCollection 2022 Oct.
PubMed 36397921
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effect of Photobiomodulation and Electrical Stimulation on Facial Disability Among Bell's Palsy Patients
- ClinicalTrials.gov ID
- NCT07266636
- Acronym / sponsor ID
- UBAS/ERB/FoRS/25/037 Kashaf
- Conditions
- Bell's Palsy
- Keywords
- Photobiomodulation, Electrical Muscle Stimulation, Facial Exercises
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Lahore University of Biological and Applied SciencesUniversity, hospital or other
- Study start
- 25 Nov 2025 (estimated)
- Primary completion
- 25 May 2026 (estimated)
- Study completion
- 25 May 2026 (estimated)
- First posted
- 5 Dec 2025 (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.
Despite promising evidence supporting both photobiomodulation (PBM) and electrical stimulation (ES) in Bell's palsy rehabilitation, key gaps remain in the literature. Few studies have directly compared these modalities under standardized conditions, especially while keeping facial exercises constant across groups. Inconsistent treatment parameters such as variations in PBM wavelength or ES intensity limit the comparability and replication of existing findings. Additionally, many studies rely on subjective outcome measures and lack structured timelines for assessing facial symmetry, neuromuscular coordination, or long-term recovery, including complications like synkinesis. These limitations highlight the need for a well-controlled comparative study to determine the more effective modality when paired with consistent facial rehabilitation exercises.
Detailed description
Bell's palsy is the most common form of lower motor neuron facial paralysis, accounting for approximately 60-75% of such cases. Although the exact cause remains unknown, it is often linked to viral infections that trigger inflammation of the facial nerve, leading to localized swelling, loss of myelin sheath, and reduced blood flow. Several factors have been identified that may increase susceptibility to the condition, including elevated blood glucose levels, poorly managed hypertension, severe pre-eclampsia, migraines, and exposure to radiation. Patients experience either partial or complete facial weakness, often accompanied by numbness, discomfort, sensitivity to sound, and changes in taste. Bell's palsy is primarily diagnosed through clinical assessment, with other potential causes being ruled out.
Among the various rehabilitative strategies, photobiomodulation (PBM) and electrical stimulation (ES) have gained significant attention. Both are non-invasive therapeutic modalities used to stimulate nerve regeneration, reduce inflammation, and promote muscle function. However, comparative studies evaluating their effectiveness in treating facial disability due to Bell's palsy remain limited. This study, therefore, aims to investigate the comparative effects of PBM and ES on facial disability in patients suffering from Bell's palsy, helping clinicians make evidence-informed decisions for optimal patient outcomes.
Physiotherapy plays a crucial role in Bell's palsy rehabilitation by targeting neuromuscular facilitation, enhancing synaptic activity, and restoring functional facial expressions. Photobiomodulation therapy, previously referred to as low-level laser therapy (LLLT), employs low-intensity lasers or light-emitting diodes (LEDs) to deliver light energy into tissues. This energy is absorbed by chromophores in cells, especially cytochrome c oxidase, triggering a cascade of biochemical events that stimulate ATP production, modulate reactive oxygen species (ROS), and reduce inflammation. These effects create a favorable environment for nerve regeneration and tissue healing.
Electrical stimulation involves applying controlled electrical currents through the skin to elicit muscle contractions. By stimulating the facial nerve or its motor endplates, ES is thought to maintain muscle tone, prevent atrophy, and potentially re-educate facial muscles through repetitive activation. Different protocols involve varying frequencies and waveforms, with surface electrodes most commonly used in clinical practice. The theoretical underpinning of both PBM and ES lies in the concept of neuroplasticity and tissue responsiveness to bioelectrical and biochemical signals. However, the optimal modality, timing, and dosage for facial nerve rehabilitation remain areas of ongoing research and debate, necessitating further empirical investigation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Group A: The participants will recieve Photobiomodulation therapy alongwith facial exercises Group B: The participants will receive Electrical Muscle Stimulation alongwith facial exercises
| Arm | Type | Receives |
|---|---|---|
| Photobiomodulation along with facial exercises | Experimental | Radiation: Photobiomodulation alongwith facial exerciseGroup A will receive Photobiomodulation therapy alongwith facial exercises. The intervention phase will last for 5-6 weeks, with participants receiving treatment 4-5 times per week, each session lasting 30-40 minutes, under therapist supervision. |
| Electrical Muscle Stimulation alongwith facial exercises | Active comparator | Other: Electrical Stimulation alongwith facial exerciseGroup B will receive Electrical Muscle Stimulation therapy alongwith facial exercises. The intervention phase will last for 5-6 weeks, with participants receiving treatment 4-5 times per week, each session lasting 30-40 minutes, under therapist supervision. Group A |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Participants diagnosed with idiopathic Bell's palsy by the Physicians, moderate to severe facial muscle weakness i.e. grade III-VI on the House-Brackmann scale and duration of the condition less than 2 weeks are the inclusion criteria Exclusion Criteria
- Participants with a middle ear infection, parotid gland tumor, malignant otitis externa, tumors in the base of the lateral skull, upper motor neuron facial palsy, segmental muscle weakness, recurrent episodes of facial paralysis, polyneuropathies and Ramsay Hunt Syndrome will be excluded from the study.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Photobiomodulation alongwith facial exerciseThe intervention phase will last for 5-6 weeks, with participants receiving treatment 4-5 times per week, each session lasting 30-40 minutes, under therapist supervision. PBM therapy will be administered using a low-level laser therapy (LLLT) device, with appropriate settings (e.g., wavelength, energy density, and duration). Each session will focus on treating the affected facial regions. Facial Exercise will include manual therapy aimed at improving facial muscle tone, mobility, and circulation, customized for Bell's Palsy. | Radiation | Photobiomodulation along with facial exercises |
| Electrical Stimulation alongwith facial exerciseThe intervention phase will last for 5-6 weeks, with participants receiving treatment 4-5 times per week, each session lasting 30-40 minutes, under therapist supervision. EMS will be applied to the affected facial muscles using appropriate device settings. The therapy will focus on stimulating motor function and improving muscle tone. Facial Exercise will be performed as described above in Group 1 to aid in relaxation and muscle tone restoration. | Other | Electrical Muscle Stimulation alongwith facial exercises |
Primary outcome
House-Brackmann Facial Nerve Grading System
Time frame: Baseline After 6 weeks
The HB scale categorizes facial nerve function into six grades, ranging from Grade I (normal function) to Grade VI (complete paralysis), based on assessments of symmetry at rest, degree of voluntary movement, and presence of synkinesis. It is widely used to assess the severity of facial palsy, monitor recovery after surgery or treatment, and track the progress of rehabilitation. The grading considers both resting facial appearance and movement during actions like raising the eyebrow and smiling
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 5 Dec 2025.
- Results publication: PubMed 33471046Glass GE. Photobiomodulation: The Clinical Applications of Low-Level Light Therapy. Aesthet Surg J. 2021 May 18;41(6):723-738. doi: 10.1093/asj/sjab025.
- Results publication: PubMed 34417505Kim MH, Park SY. Population-based study and a scoping review for the epidemiology and seasonality in and effect of weather on Bell's palsy. Sci Rep. 2021 Aug 20;11(1):16941. doi: 10.1038/s41598-021-96422-4.
- Results publication: PubMed 31172187Rasooly D, Ioannidis JPA, Khoury MJ, Patel CJ. Family History-Wide Association Study to Identify Clinical and Environmental Risk Factors for Common Chronic Diseases. Am J Epidemiol. 2019 Aug 1;188(8):1563-1568. doi: 10.1093/aje/kwz125.
- Results publication: PubMed 36397921Singh A, Deshmukh P. Bell's Palsy: A Review. Cureus. 2022 Oct 11;14(10):e30186. doi: 10.7759/cureus.30186. eCollection 2022 Oct.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation alongwith facial exercise and Electrical Stimulation alongwith facial exercise in people with Bell's Palsy, run by Lahore University of Biological and Applied Sciences.
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 2 inclusion and 0 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 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Kashaf Nadeem, DPT (+923169819979, kashafn52@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
House-Brackmann Facial Nerve Grading System (time frame: Baseline After 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07266636, which also lists 4 linked publications.
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 5 Dec 2025.