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Low Laser Therapy on Facial Motor Functions Function and Synkinesis in Patients With Bell's Palsy

Primary Purpose

Bell's Palsy

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Low level laser therapy and conventional therapy
Conventional therapy
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bell's Palsy

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ali razaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Low level laser therapy

Conventional therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Facial disability index
To access the physical well-being
Housebrackmann scale
To grade the facial muscle weakness
Sunnybrook facial grading
To acess symmetry and synkinesis

Secondary Outcome Measures

Full Information

First Posted
January 22, 2023
Last Updated
January 22, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05707091
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
March 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bell's Palsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low level laser therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Low level laser therapy and conventional therapy
Intervention Description
One group treated with low level laser therapy along with conventional therapy
Intervention Type
Procedure
Intervention Name(s)
Conventional therapy
Intervention Description
Group B treated with ems and exercises
Primary Outcome Measure Information:
Title
Facial disability index
Description
To access the physical well-being
Time Frame
4 weeks
Title
Housebrackmann scale
Description
To grade the facial muscle weakness
Time Frame
4 weeks
Title
Sunnybrook facial grading
Description
To acess symmetry and synkinesis
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ali Raza, MsOMPT
Phone
03326099065
Email
araza.frahs@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Raza, MsOmpt
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ali raza
City
Lahore
State/Province
Punjab
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Raza, MsOMPT
Phone
03326099065
Email
araza.frahs@riphah.edu.pk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32802293
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.
Results Reference
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PubMed Identifier
28337563
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;:
Results Reference
background
PubMed Identifier
26226172
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.
Results Reference
background
PubMed Identifier
23709010
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.
Results Reference
background
PubMed Identifier
32463963
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.
Results Reference
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Low Laser Therapy on Facial Motor Functions Function and Synkinesis in Patients With Bell's Palsy

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