Effect of Neural Mobilization in Bells Palsy: A Randomized Controlled Trial

Bells palsy is a sudden paralysis of half of the facial muscle. The BP is idiopathic and 70% responds well with drug therapy. There are many complementary therapies such as , tapping, electrical stimulation, and massage that adds to the recovery of condition. However, efficacy of neural mobilization in BP is not reported in the scientific literature.

Study Overview

• Status: Completed
• Conditions: Bell Palsy
• Intervention / Treatment: Other: Neural Mobilisation; Other: Massage therapy; Diagnostic test: Faradic electrical stimulation; Other: Exercises

Detailed Description

Bells Palsy responds well with drug therapy such as prednisolone and antiviral drugs for the duration of 10-12 days. However, the administration of these drugs produce adverse side effect. Therapist use a number of techniques to maintain the physiological properties of facial muscles. However, adding a new technique would add to the arsenal of techniques available for the therapist. The research is intended to determine the effect of adding Neural mobilization in the recovery of Bells Palsy. A randomized controlled trail is intended to include 60 participants divided into two groups. Experimental group will receive Neural Mobilization with conservative treatment and control group will receive conservative treatment only.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • UP
    • Ghāziābād, UP, India, 201206
      • IAMR
    • Meerut, UP, India, 15341
      • Faizan Kashoo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The first episode of Bell's palsy.
• Modified House-Brackmann scale III-IV.

Exclusion Criteria:

• Diabetic
• Recurrent Bells palsy
• facial palsy
• History of stroke
• Any cerebrovascular accident
• epilepsy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Neural Mobilisation Group; Massage therapy.; Faradic electrical stimulation.; Exercises in front of the mirror.; Neural mobilization was applied by gently holding the lower part of the ear between the index finger and thumb. The thumb was placed at the opening of the external auditory meatus and the index finger placed behind the auricle of the ear (Figure 2). The intensity of auricular traction was determined by the patient reporting the level of discomfort. The patient tolerated 3-4 sets of gentle horizontal traction and circular movement 25 times each with 5 seconds rest.	Other: Neural Mobilisation; Neural mobilization was applied by gently holding the lower part of the ear between the index finger and thumb. The thumb was placed at the opening of the external auditory meatus and the index finger placed behind the auricle of the ear (Figure 2). The intensity of auricular traction was determined by the patient reporting the level of discomfort. The patient tolerated 3-4 sets of gentle horizontal traction and circular movement 25 times each with 5 seconds rest.; Other: Massage therapy; Massage therapy consisting of tapping, effleurage and finger and thumb kneading for 15-16 minutes.; Diagnostic test: Faradic electrical stimulation; Faradic electrical stimulation with anode electrode at the back of the neck and cathode over the nerve trunk anterior to the earlobe. The cathodic pen electrode was used to locate the facial nerve trunk for stimulation manually. (Biphasic current, pulse time 300 microseconds, frequency 60 Hz, 20 contractions, Rest 10 seconds). The total treatment time was 15 minutes.; Other: Exercises; Exercises in front of the mirror like raising the eyebrow, clinching the teeth (patient trying to see his clenched teeth in the mirror), smiling and performing other facial expressions for 12-15 minutes.
Active Comparator: Conservative group; Massage therapy consisting of tapping, effleurage and finger and thumb kneading for 15-16 minutes.; Faradic electrical stimulation with anode electrode at the back of the neck and cathode over the nerve trunk anterior to the earlobe. The cathodic pen electrode was used to locate the facial nerve trunk for stimulation manually. (Biphasic current, pulse time 300 microseconds, frequency 60 Hz, 20 contractions, Rest 10 seconds). The total treatment time was 15 minutes.; Exercises in front of the mirror like raising the eyebrow, clinching the teeth (patient trying to see his clenched teeth in the mirror), smiling and performing other facial expressions for 12-15 minutes.	Other: Massage therapy; Massage therapy consisting of tapping, effleurage and finger and thumb kneading for 15-16 minutes.; Diagnostic test: Faradic electrical stimulation; Faradic electrical stimulation with anode electrode at the back of the neck and cathode over the nerve trunk anterior to the earlobe. The cathodic pen electrode was used to locate the facial nerve trunk for stimulation manually. (Biphasic current, pulse time 300 microseconds, frequency 60 Hz, 20 contractions, Rest 10 seconds). The total treatment time was 15 minutes.; Other: Exercises; Exercises in front of the mirror like raising the eyebrow, clinching the teeth (patient trying to see his clenched teeth in the mirror), smiling and performing other facial expressions for 12-15 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sunnybrook facial assessment scale	Sunnybrook facial assessment scale is a scale to assess quantitatively the facial asymmetry. It is a weighted scale based on evaluation of 3 different sub-scale including resting symmetry, the symmetry of voluntary movement, and severity of synkinesis to form one single composite score from 0 to 100. Firstly, the physiotherapist assesses the symmetry of the eye (0-1), cheek (0-2), and mouth (0-1) at rest. (0=normal, the weighted factor of 5). Secondly, the Physiotherapist rates facial movements during 5 standard facial expressions: a brow lift, gentile eye closure, open mouth smile, snarl and lip pucker, on a scale of 1 to 5 (1=no movement, to 5=normal movement). The values are added together and multiplied by 4. In the 3rd step, the severity of synkinesis on a 3-point scale (0=none, to 3=severe) during the 5 expressions as in the 2nd step. The overall score is given by the symmetry value of the voluntary movements minus the resting symmetry and the synkinesis.	1 year
Kinovea© tool for facial movement analysis	As a secondary outcome, we used Kinovea©, a free and open-source tool for movement analysis (Kinovea©, 0.8.15 2006 to 2011; Joan Charmant & Contrib, Bordeaux, France). From plain video-recordings of movements, the software allows measuring distances and times, manually or using semi-automated tracking to follow points and check live values or trajectories. Facial distances were measured after maximal contractions movements of 3 selected facial muscles: frontalis, orbicularis oris, zygomatic. A symmetry ratio calculated comparing sides of each movement pattern. Subjects had to look straight ahead towards a specified target fixed on the facing wall and it was asked them not to move during video acquisitions. It was asked to keep the head lean the wall, keeping firm it during the 3 tested movements.	1 year

Collaborators and Investigators

• Sponsor: Majmaah University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Actual): May 15, 2021
• Study Completion (Actual): May 20, 2021

Study Registration Dates

• First Submitted: February 19, 2020
• First Submitted That Met QC Criteria: February 20, 2020
• First Posted (Actual): February 21, 2020

Study Record Updates

• Last Update Posted (Actual): June 23, 2021
• Last Update Submitted That Met QC Criteria: June 17, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Virus Diseases; Infections; Neurologic Manifestations; Stomatognathic Diseases; Mouth Diseases; DNA Virus Infections; Cranial Nerve Diseases; Herpesviridae Infections; Paralysis; Facial Nerve Diseases; Bell Palsy; Facial Paralysis
• Other Study ID Numbers: MU-1441-99

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No