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

Not Applicable

Recruiting

• Conditions: Bell's Palsy
• Interventions: Other: Low level laser therapy and conventional therapy; Procedure: Conventional therapy

• Registration Number: NCT05707091
• Lead Sponsor: Riphah International University

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.

Study Timeline

• Status Verified: 2023-01
• Study Start: 2023-01-01
• Study First Submitted: 2023-01-22
• Study First Submitted QC: 2023-01-22
• Last Update Submitted: 2023-01-22
• Study First Posted: 2023-01-31
• Last Update Posted: 2023-01-31
• Primary Completion: 2023-03-01
• Study Completion: 2023-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 32

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low level laser therapy	Low level laser therapy and conventional 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.
Conventional therapy	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Ali raza; 🇵🇰 Lahore, Punjab, Pakistan