- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07266636
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
Study Overview
Status
Conditions
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kashaf Nadeem, DPT
- Phone Number: +923169819979
- Email: kashafn52@gmail.com
Study Contact Backup
- Name: Nabeela Dawood, MS-NMPT
- Phone Number: +923315337445
- Email: nabeela.dawood@ubas.edu.pk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
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
Publications and helpful links
General 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.
- Kim 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.
- Rasooly 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.
- Singh A, Deshmukh P. Bell's Palsy: A Review. Cureus. 2022 Oct 11;14(10):e30186. doi: 10.7759/cureus.30186. eCollection 2022 Oct.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UBAS/ERB/FoRS/25/037 Kashaf
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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