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

NCT ID: NCT07191808

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-31
• Study Completion Date: 2025-12-31

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

Detailed Description

Annually, incidence of Bell's Palsy ranges between 1 to 4 per 10,000 individuals globally. From Pakistan figures highlight that the incidence rate of Bell's palsy in Pakistan may be above the international average, with many patients reporting a decline in their quality-of-life post diagnosis.

Low-Level Laser Therapy (LLLT), a modality known as photobiomodulation, has woven its way through various medical settings over the past decades. It has found applications in promoting wound healing, alleviating musculoskeletal pain, and now is being explored in the realm of neurological recovery. This non-invasive therapeutic technique employs non-thermal lasers or LEDs, aiming to stimulate and enhance the functions of our cellular machinery.

Globally Studies have proved effectiveness of Low Level LASER therapy in Bell's Palsy, with reduction of recovery time, improvement of Quality of Life and Personal wellbeing of patients of Bell's Palsy. We performed a survey exploring treatment preferences of Physical Therapy Clinicians to treat patients with Bell's Palsy; result showed routine contemporary practices of physiotherapy with Low Level LASER Therapy were low as 8% professionals.

The target population in this study will be assessed with standard outcome measures including FDI, HBS, FNLT / NCS and SBFGS. Two outcome measures FDI and HBS has been translated in Urdu and Reliability Studies have also been completed with permission from the Authors. A Case Control study has also been completed considering the risk factors for patients with Bell's Palsy. A Systematic Review completed by the researcher also found the Gap to explore the effectiveness of Low Level LASER Therapy for patients with Bell's Palsy.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

low level LASER

for neuroplasticity

Group Type: OTHER

Low Level Laser Therapy

Intervention Type: OTHER

cluster method

Interventions

Low Level Laser Therapy

cluster method

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• • 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.

Exclusion Criteria

• • 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)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Lahore

OTHER

Sponsor Role: lead

Responsible Party

Shahid Ahmed

Shahid Ahmed

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Prof Dr Ashfaq Ahmed, PhD

Role: STUDY_DIRECTOR

University of Lahore

Locations

NACE

Faisalābad, , Pakistan

Countries

Pakistan

Other Identifiers

UoL

Identifier Type: -

Identifier Source: org_study_id