Bell Palsybells palsyNCT07191808
EXPLORING EFFECTIVENESS OF LOW LEVEL LASER THERAPY IN THE TREATMENT OF PATIENTS WITH BELLS PALSY
A study testing Low Level Laser Therapy in people with Bell Palsy and Bell's Palsy, run by University of Lahore at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bell Palsy, Bell's Palsy
- What is being tested?
- Low Level Laser Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- Oct 2025to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- • 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.
Who cannot join
- • 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.
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
Read the 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
- Being tested
- Low Level Laser Therapy
- Keywords
- LLLT, Photmodulation, Low Leel LASER Thrapy, Idiopathic, 7th Nerve Palsy, Pakistan, Bells's Palsy, Bell's
- Medical subject headings
- Bell Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Level Laser TherapyOther
cluster method
| Study group | Role | What they receive |
|---|---|---|
| low level LASER | Other | for neuroplasticity Receives: Other: Low Level Laser Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study startOct 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bell PalsyStudies of the same condition, open and under way.
- More trials run by University of LahoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahid Ahmed, University of Lahore
- Investigators
- Prof Dr Ashfaq Ahmed, PhD, Study director, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07191808
- Sponsor's protocol ID
- UoL
- Acronym
- bells palsy
- Status last verified
- Sep 2025
- First submitted
- 22 Jul 2025
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EXPLORING EFFECTIVENESS OF LOW LEVEL LASER THERAPY IN THE TREATMENT OF PATIENTS WITH BELLS PALSY
- ClinicalTrials.gov ID
- NCT07191808
- Acronym / sponsor ID
- bells palsy / UoL
- Conditions
- Bell Palsy, Bell's Palsy
- Keywords
- LLLT, Photmodulation, Low Leel LASER Thrapy, Idiopathic, 7th Nerve Palsy, Pakistan, Bells's Palsy, Bell's
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 25 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| low level LASER | Other | Other: Low Level Laser Therapyfor neuroplasticity |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- • A confirmed diagnosis of idiopathic facial (Bell's) palsy by a certified neurologist or Physician is required (Heckmann, Urban, Pitz, Guntinas-Lichius, \& Gágyor, 2019).
Key exclusion criteria (10 listed)
- • Alternate diagnoses that can explain Bell's palsy (e.g., Lyme disease, Ramsay Hunt syndrome) (Crouch, Hohman, Moody, \& Andaloro, 2023).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Level Laser Therapycluster method | Other | low level LASER |
Primary outcome
House-Brackmann Score
Time frame: 6 weeks
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Prof Dr Ashfaq Ahmed, PhD study director
University of Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Level Laser Therapy in people with Bell Palsy and Bell's Palsy, run by University of Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
House-Brackmann Score (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.