EXPLORING EFFECTIVENESS OF LOW LEVEL LASER THERAPY IN THE TREATMENT OF PATIENTS WITH BELLS PALSY

NCT07191808 | Enrolling By Invitation DMC

• 1 other identifier: UoL
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the proposed research is to explore effectiveness of Low Level LASER Therapy in the country and to compare its effectiveness with routine physiotherapy. The societal benefit of submitted research is to formulate a guideline for physical therapy clinicians of the country to treat patients with Bell's Palsy through modern tool of Low Level LASER Therapy if found effective for improvement in quality of lives

Conditions

Bell Palsy; Bell's Palsy

Keywords

LLLT; Photmodulation; Low Leel LASER Thrapy; Idiopathic; 7th Nerve Palsy; Pakistan; Bells's Palsy; Bell's

Outcome Measures

Primary Outcomes (1)

• House-Brackmann Score

  This scale is recognized for its capability to grade facial nerve dysfunction levels. The primary indicator of the treatment's efficacy will be any discernible improvement or non-worsening on this scale

  6 weeks

Study Arms (1)

low level LASER

OTHER

for neuroplasticity

Other: Low Level Laser Therapy

Interventions

Low Level Laser Therapy OTHER

cluster method

low level LASER

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• A confirmed diagnosis of idiopathic facial (Bell's) palsy by a certified neurologist or Physician is required (Heckmann, Urban, Pitz, Guntinas-Lichius, \& Gágyor, 2019).
• Both male and female patients, aged between 18 and 80 years (Holland \& Bernstein, 2014).
• Symptom onset within the range of 72 hours to 7 days (Petruzzelli \& Hirsch, 1991).
• A baseline House-Brackmann score of 2 to 4 is necessary (Bylund et al., 2021).
• Availability for the entire trial duration and all subsequent follow-up visits.
• Absence of any prior treatments (e.g., corticosteroids) for the current Bell's palsy episode.

You may not qualify if:

• Alternate diagnoses that can explain Bell's palsy (e.g., Lyme disease, Ramsay Hunt syndrome) (Crouch, Hohman, Moody, \& Andaloro, 2023).
• History of recurrent Bell's palsy episodes.
• Presence of severe medical conditions such as uncontrolled diabetes or autoimmune disorders.
• Pregnancy or lactation. Use of concurrent medications that could interfere with facial nerve function.
• Exposure to LLLT in the past 3 months.
• Active skin infections or lesions in the targeted treatment area.
• Conditions or medications that induce photosensitivity.
• Cognitive impairments that may interfere with comprehension or feedback about the trial.
• Participation in another trial in the past month.
• Traumatic, inflammatory, or infectious conditions including trauma, nerve root issues, metabolic/spinal pathologies, previous spinal surgeries, or postpartum pain due to pregnancy (Singh \& Deshmukh, 2022)

Sponsors & Collaborators

• University of Lahore: lead

Study Sites (1)

NACE

Faisalābad, 38090, Pakistan

Location

MeSH Terms

Conditions

Bell Palsy

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Mouth Diseases; Stomatognathic Diseases; Facial Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Prof Dr Ashfaq Ahmed, PhD

  University of Lahore

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Shahid Ahmed

Model Details: A randomized controlled trial will be designed to assess the efficacy of Low-Level Laser Therapy in comparison to EMS treatment for patients diagnosed with idiopathic Bell's palsy

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: September 25, 2025
• Study Start: October 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 25, 2025

Record last verified: 2025-09

Locations

PA (1)