Clinical trial NCT05707091: Low Laser Therapy on Facial Motor Functions Function and Synkinesis in Patients With Bell's Palsy
Official title: Effects of Low Laser Therapy on Facial Motor Functions Function and Synkinesis in Patients With Bell's Palsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bell's Palsy
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-01-31
Enrollment: 32
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Facial disability index
timeFrame: 4 weeks
measure: Housebrackmann scale
timeFrame: 4 weeks
measure: Sunnybrook facial grading
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Ali raza
state: Punjab
Study officials:
affiliation: Riphah International University
name: Ali Raza, MsOmpt
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.
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.