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

Sponsor

Riphah International University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05707091

Collaborator

(none)

Enrollment

Location

Arms

1.9

Anticipated Duration (Months)

16.5

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Bell's Palsy	Other: Low level laser therapy and conventional therapy Procedure: Conventional therapy	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Low level laser therapy 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 One group treated with low level laser therapy along with conventional therapy
Experimental: Conventional therapy 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 Group B treated with ems and exercises

Arm

Intervention/Treatment

Experimental: Low level laser therapy

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

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

Experimental: Conventional therapy

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

Group B treated with ems and exercises

Outcome Measures

Primary Outcome Measures

Facial disability index [4 weeks]
To access the physical well-being
Housebrackmann scale [4 weeks]
To grade the facial muscle weakness
Sunnybrook facial grading [4 weeks]
To acess symmetry and synkinesis

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ali raza	Lahore	Punjab	Pakistan

Sponsors and Collaborators

Riphah International University

Investigators

Principal Investigator: Ali Raza, MsOmpt, Riphah International University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Riphah International University

ClinicalTrials.gov Identifier:

NCT05707091

Other Study ID Numbers:

REC/RCR&AHS/22/0216

First Posted:

Jan 31, 2023

Last Update Posted:

Jan 31, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Bell Palsy

Facial Paralysis

Synkinesis

Study Results

No Results Posted as of Jan 31, 2023