Bell's PalsyNCT05707091
Low Laser Therapy on Facial Motor Functions Function and Synkinesis in Patients With Bell's Palsy
A study testing Low level laser therapy and conventional therapy and Conventional therapy in people with Bell's Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
To determine the effects of low-level laser therapy on facial motor functions and synkinesis in patients with bell's palsy Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Bell's Palsy
- What is being tested?
- Low level laser therapy and conventional therapy and Conventional therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2023to 1 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male female diagnosed with idiopathic Bell's palsy by physician
- age 30-60years
- Bell's palsy in patients having known history of hypertension
- Bell's palsy in patients having known history of diabetes
Who cannot join
- Participants with a middle ear infection
- parotid gland tumor
- malignant otitis external
- Tumors in the base of the lateral skull
- upper motor neuron facial palsy
- segmental muscle weakness
- and recurrent episodes of facial paralysis, polyneuropathies
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Ali raza
Lahore, Punjab Province
Ali Raza, MsOMPT, 03326099065, araza.frahs@riphah.edu.pk
About this study
Official title: Effects of Low Laser Therapy on Facial Motor Functions Function and Synkinesis in Patients With Bell's Palsy
To determine the effects of low-level laser therapy on facial motor functions and synkinesis in patients with bell's palsy
Read the detailed description
A randomised controlled trial tested low-level laser therapy (LLLT) for bell's palsy. Lahore's Ittefaq Hospital selected 32 bell's palsy patients for the research. The Facial Disability Index (FDI), House-Brackmann Scale (HBS), and Sunnybrook Facial Grading System were used to collect data over ten months (SFG). LLLT and conventional therapy were randomly assigned to two groups. SPSS 25 compared pre- and post-treatment values of the two groups.
- Conditions
- Bell's Palsy
- Being tested
- Low level laser therapy and conventional therapy, Conventional therapy
- 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 therapy and conventional therapyOther
One group treated with low level laser therapy along with conventional therapy
Conventional therapyProcedure or surgery
Group B treated with ems and exercises
| Study group | Role | What they receive |
|---|---|---|
| Low level laser therapy | Experimental | Patients assigned to experimental group received low level laser therapy and conventional therapy. Treatment frequency was five sessions/week for 4 weeks. . For laser therapy, Omega laser system used with infrared probes of 830 nm wavelength and 100 mW output power, average energy density of 10 J/cm2 , frequency of 1 KHz, and a duty cycle of 80 % in one group. In all cases, the laser was in direct contact with the superficial roots of the facial nerve on the affected side. And was applied for 2 min and 5 s per point for 8 points. Receives: Other: Low level laser therapy and conventional therapy |
| Conventional therapy | Experimental | Group B was treated with conventional therapy. The interrupted galvanic electrical impulses with the duration of 3-30 milliseconds, the tolerable intensity was applied over the motor points of each facial muscle. A total of 30-60 electrical twitch induced muscle contractions will be maintained for each muscle. The facial muscles exercise training with mirror-visual feedback was progressed to resisted exercises by self and/or therapist-assistance. All exercises were demonstrated to participants by the therapist's efforts and instructed the participants to continue the exercises twice a day for 10-15 minutes. A pictorial leaflet of facial expressions exercises with appropriate instructions to perform exercises. Treatment frequency was five sessions/week for 4 weeks. Receives: Procedure: Conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Facial disability index
To access the physical well-being
Measured: 4 weeks
Housebrackmann scale
To grade the facial muscle weakness
Measured: 4 weeks
Sunnybrook facial grading
To acess symmetry and synkinesis
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start1 Jan 2023
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Bell's PalsyStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ali Raza, MsOmpt, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05707091
- Sponsor's protocol ID
- REC/RCR&AHS/22/0216
- Status last verified
- Jan 2023
- First submitted
- 22 Jan 2023
- Last updated
- 31 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aghamohamdi D, Fakhari S, Farhoudi M, Farzin H. The Efficacy of Low-Level Laser Therapy in the Treatment of Bell's Palsy in Diabetic Patients. J Lasers Med Sci. 2020 Summer;11(3):310-315. doi: 10.34172/jlms.2020.52. Epub 2020 Jun 21.
PubMed 32802293Ordahan B, Karahan AY. Role of low-level laser therapy added to facial expression exercises in patients with idiopathic facial (Bell's) palsy. Lasers Med Sci. 2017 May;32(4):931-936. doi: 10.1007/s10103-017-2195-9. Epub 2017 Mar 23.
PubMed 28337563de Oliveira RF, da Silva AC, Simoes A, Youssef MN, de Freitas PM. Laser Therapy in the Treatment of Paresthesia: A Retrospective Study of 125 Clinical Cases. Photomed Laser Surg. 2015 Aug;33(8):415-23. doi: 10.1089/pho.2015.3888.
PubMed 26226172Alayat MS, Elsodany AM, El Fiky AA. Efficacy of high and low level laser therapy in the treatment of Bell's palsy: a randomized double blind placebo-controlled trial. Lasers Med Sci. 2014 Jan;29(1):335-42. doi: 10.1007/s10103-013-1352-z. Epub 2013 May 26.
PubMed 23709010Bylund N, Hultcrantz M, Jonsson L, Marsk E. Quality of Life in Bell's Palsy: Correlation with Sunnybrook and House-Brackmann Over Time. Laryngoscope. 2021 Feb;131(2):E612-E618. doi: 10.1002/lary.28751. Epub 2020 May 28.
PubMed 32463963
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Low Laser Therapy on Facial Motor Functions Function and Synkinesis in Patients With Bell's Palsy
- ClinicalTrials.gov ID
- NCT05707091
- Acronym / sponsor ID
- REC/RCR&AHS/22/0216
- Conditions
- Bell's Palsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 31 Jan 2023 (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.
To determine the effects of low-level laser therapy on facial motor functions and synkinesis in patients with bell's palsy
Detailed description
A randomised controlled trial tested low-level laser therapy (LLLT) for bell's palsy. Lahore's Ittefaq Hospital selected 32 bell's palsy patients for the research. The Facial Disability Index (FDI), House-Brackmann Scale (HBS), and Sunnybrook Facial Grading System were used to collect data over ten months (SFG). LLLT and conventional therapy were randomly assigned to two groups. SPSS 25 compared pre- and post-treatment values of the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low level laser therapy | Experimental | Other: Low level laser therapy and conventional therapyPatients assigned to experimental group received low level laser therapy and conventional therapy. Treatment frequency was five sessions/week for 4 weeks. . For laser therapy, Omega laser system used with infrared probes of 830 nm wavelength and 100 mW output power, average energy density of 10 J/cm2 , frequency of 1 KHz, and a duty cycle of 80 % in one group. In all cases, the laser was in direct contact with the superficial roots of the facial nerve on the affected side. And was applied for 2 min and 5 s per point for 8 points. |
| Conventional therapy | Experimental | Procedure: Conventional therapyGroup B was treated with conventional therapy. The interrupted galvanic electrical impulses with the duration of 3-30 milliseconds, the tolerable intensity was applied over the motor points of each facial muscle. A total of 30-60 electrical twitch induced muscle contractions will be maintained for each muscle. The facial muscles exercise training with mirror-visual feedback was progressed to resisted exercises by self and/or therapist-assistance. All exercises were demonstrated to participants by the therapist's efforts and instructed the participants to continue the exercises twice a day for 10-15 minutes. A pictorial leaflet of facial expressions exercises with appropriate instructions to perform exercises. Treatment frequency was five sessions/week for 4 weeks. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male female diagnosed with idiopathic Bell's palsy by physician
- age 30-60years
- Bell's palsy in patients having known history of hypertension
- Bell's palsy in patients having known history of diabetes
Key exclusion criteria (7 listed)
- Participants with a middle ear infection
- parotid gland tumor
- malignant otitis external
- Tumors in the base of the lateral skull
- upper motor neuron facial palsy
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 therapy and conventional therapyOne group treated with low level laser therapy along with conventional therapy | Other | Low level laser therapy |
| Conventional therapyGroup B treated with ems and exercises | Procedure or surgery | Conventional therapy |
Primary outcome
Facial disability index
Time frame: 4 weeks
To access the physical well-being
Housebrackmann scale
Time frame: 4 weeks
To grade the facial muscle weakness
Sunnybrook facial grading
Time frame: 4 weeks
To acess symmetry and synkinesis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- Background: PubMed 32802293Aghamohamdi D, Fakhari S, Farhoudi M, Farzin H. The Efficacy of Low-Level Laser Therapy in the Treatment of Bell's Palsy in Diabetic Patients. J Lasers Med Sci. 2020 Summer;11(3):310-315. doi: 10.34172/jlms.2020.52. Epub 2020 Jun 21.
- Background: PubMed 28337563Ordahan B, Karahan AY. Role of low-level laser therapy added to facial expression exercises in patients with idiopathic facial (Bell's) palsy. Lasers Med Sci. 2017 May;32(4):931-936. doi: 10.1007/s10103-017-2195-9. Epub 2017 Mar 23.
- Background: PubMed 26226172de Oliveira RF, da Silva AC, Simoes A, Youssef MN, de Freitas PM. Laser Therapy in the Treatment of Paresthesia: A Retrospective Study of 125 Clinical Cases. Photomed Laser Surg. 2015 Aug;33(8):415-23. doi: 10.1089/pho.2015.3888.
- Background: PubMed 23709010Alayat MS, Elsodany AM, El Fiky AA. Efficacy of high and low level laser therapy in the treatment of Bell's palsy: a randomized double blind placebo-controlled trial. Lasers Med Sci. 2014 Jan;29(1):335-42. doi: 10.1007/s10103-013-1352-z. Epub 2013 May 26.
- Background: PubMed 32463963Bylund N, Hultcrantz M, Jonsson L, Marsk E. Quality of Life in Bell's Palsy: Correlation with Sunnybrook and House-Brackmann Over Time. Laryngoscope. 2021 Feb;131(2):E612-E618. doi: 10.1002/lary.28751. Epub 2020 May 28.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Ali Raza, MsOmpt principal investigator
Riphah International University
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 and conventional therapy and Conventional therapy in people with Bell's Palsy, run by Riphah International University 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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 31 Jan 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ali Raza, MsOMPT (03326099065, araza.frahs@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Facial disability index (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05707091, which also lists 5 linked publications.
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 31 Jan 2023.