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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05707091
Other study ID # REC/RCR&AHS/22/0216
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2023
Est. completion date March 1, 2023

Study information

Verified date January 2023
Source Riphah International University
Contact Ali Raza, MsOMPT
Phone 03326099065
Email araza.frahs@riphah.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To determine the effects of low-level laser therapy on facial motor functions and synkinesis in patients with bell's palsy


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 32
Est. completion date March 1, 2023
Est. primary completion date March 1, 2023
Accepts healthy volunteers No
Gender All
Age group 30 Years to 60 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Low level laser therapy and conventional therapy
One group treated with low level laser therapy along with conventional therapy
Procedure:
Conventional therapy
Group B treated with ems and exercises

Locations

Country Name City State
Pakistan Ali raza Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (5)

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. — View Citation

Alayat 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. — View Citation

Bylund 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. — View Citation

de 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. — View Citation

Ordahan 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. Erratum In: Lasers Med Sci. 2019 Jun 17;: — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Facial disability index To access the physical well-being 4 weeks
Primary Housebrackmann scale To grade the facial muscle weakness 4 weeks
Primary Sunnybrook facial grading To acess symmetry and synkinesis 4 weeks
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