NCT05707091

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 31, 2023

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

January 31, 2023

Status Verified

January 1, 2023

Enrollment Period

2 months

First QC Date

January 22, 2023

Last Update Submit

January 22, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Facial disability index

    To access the physical well-being

    4 weeks

  • Housebrackmann scale

    To grade the facial muscle weakness

    4 weeks

  • Sunnybrook facial grading

    To acess symmetry and synkinesis

    4 weeks

Study Arms (2)

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.

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.

Procedure: Conventional therapy

Interventions

One group treated with low level laser therapy along with conventional therapy

Low level laser therapy

Group B treated with ems and exercises

Conventional therapy

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ali raza

Lahore, Punjab Province, Pakistan

RECRUITING

Related 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.

    PMID: 32802293BACKGROUND
  • 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.

    PMID: 28337563BACKGROUND
  • 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.

    PMID: 26226172BACKGROUND
  • 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.

    PMID: 23709010BACKGROUND
  • 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.

    PMID: 32463963BACKGROUND

MeSH Terms

Conditions

Bell Palsy

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsMouth DiseasesStomatognathic DiseasesFacial Nerve DiseasesCranial Nerve DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Officials

  • Ali Raza, MsOmpt

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2023

First Posted

January 31, 2023

Study Start

January 1, 2023

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

January 31, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations