NCT07266636

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

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Nov 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Study Progress91%
Nov 2025May 2026

First Submitted

Initial submission to the registry

November 24, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

November 25, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 5, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2026

Last Updated

December 5, 2025

Status Verified

November 1, 2025

Enrollment Period

6 months

First QC Date

November 24, 2025

Last Update Submit

November 24, 2025

Conditions

Keywords

PhotobiomodulationElectrical Muscle StimulationFacial Exercises

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

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.

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

Other: Electrical Stimulation alongwith facial exercise

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.

Photobiomodulation along with 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. 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.

Electrical Muscle Stimulation alongwith facial exercises

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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.

  • 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.

MeSH Terms

Conditions

Bell Palsy

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsMouth DiseasesStomatognathic DiseasesFacial Nerve DiseasesCranial Nerve DiseasesNervous System Diseases

Central Study Contacts

Kashaf Nadeem, DPT

CONTACT

Nabeela Dawood, MS-NMPT

CONTACT

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
Model Details: Group A: The participants will recieve Photobiomodulation therapy alongwith facial exercises Group B: The participants will receive Electrical Muscle Stimulation alongwith facial exercises
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