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

NCT ID: NCT04280120

Last Updated: 2021-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2021-05-20

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Bell Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study will include a minimum of 60 participants visiting the investigator's outpatient department from 2020-2021. The equal allocation procedure will be used based on the admission of the cases.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
The participants, care provider, investigator and outcome assessor will be unaware about the allocation. The therapist performing the initial assessment and the final assessment will be same but will be unaware about the patient assignment.

Study Groups

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Neural Mobilisation Group

1. Massage therapy.
2. Faradic electrical stimulation.
3. Exercises in front of the mirror.
4. 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.

Group Type EXPERIMENTAL

Neural Mobilisation

Intervention Type OTHER

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.

Massage therapy

Intervention Type OTHER

Massage therapy consisting of tapping, effleurage and finger and thumb kneading for 15-16 minutes.

Faradic electrical stimulation

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type OTHER

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.

Conservative group

1. Massage therapy consisting of tapping, effleurage and finger and thumb kneading for 15-16 minutes.
2. 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.
3. 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.

Group Type ACTIVE_COMPARATOR

Massage therapy

Intervention Type OTHER

Massage therapy consisting of tapping, effleurage and finger and thumb kneading for 15-16 minutes.

Faradic electrical stimulation

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Massage therapy

Massage therapy consisting of tapping, effleurage and finger and thumb kneading for 15-16 minutes.

Intervention Type OTHER

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.

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Majmaah University

OTHER

Sponsor Role lead

Responsible Party

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faizan kashoo, PT

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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IAMR

Ghaziabad, Uttar Pradesh, India

Site Status

Faizan Kashoo

Meerut, Uttar Pradesh, India

Site Status

Countries

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India

Other Identifiers

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MU-1441-99

Identifier Type: -

Identifier Source: org_study_id

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