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
1 other identifier
interventional
34
0 countries
N/A
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2025
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 24, 2025
CompletedStudy Start
First participant enrolled
November 25, 2025
CompletedFirst Posted
Study publicly available on registry
December 5, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 25, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 25, 2026
December 5, 2025
November 1, 2025
6 months
November 24, 2025
November 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Baseline After 6 weeks
Study Arms (2)
Photobiomodulation along with facial exercises
EXPERIMENTALGroup 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 COMPARATORGroup 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
Interventions
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.
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.
Eligibility Criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (4)
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.
PMID: 33471046RESULTKim 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.
PMID: 34417505RESULTRasooly 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.
PMID: 31172187RESULTSingh A, Deshmukh P. Bell's Palsy: A Review. Cureus. 2022 Oct 11;14(10):e30186. doi: 10.7759/cureus.30186. eCollection 2022 Oct.
PMID: 36397921RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- outcome assessor will be blind about participants allocation. This will ensure that their evaluations are objective and not influenced by knowledge of which treatment group participants belongs to. Participants in both groups will be masked to the treatment of the other group by scheduling their sessions at different times
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 24, 2025
First Posted
December 5, 2025
Study Start
November 25, 2025
Primary Completion (Estimated)
May 25, 2026
Study Completion (Estimated)
May 25, 2026
Last Updated
December 5, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share