Effects of Photobiomodulation and Electrical Stimulation Among Bell's Palsy Patients

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.

Study Overview

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 Type

Interventional

Enrollment (Estimated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Photobiomodulation along with facial exercises
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.

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.

Active Comparator: Electrical Muscle Stimulation alongwith facial exercises
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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline After 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 25, 2025

Primary Completion (Estimated)

May 25, 2026

Study Completion (Estimated)

May 25, 2026

Study Registration Dates

First Submitted

November 24, 2025

First Submitted That Met QC Criteria

November 24, 2025

First Posted (Actual)

December 5, 2025

Study Record Updates

Last Update Posted (Actual)

December 5, 2025

Last Update Submitted That Met QC Criteria

November 24, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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