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

NCT04280120 | Completed DMC

• 1 other identifier: MU-1441-99
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Bell Palsy

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Neural Mobilisation Group

EXPERIMENTAL

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.

Other: Neural Mobilisation; Other: Massage therapy; Diagnostic Test: Faradic electrical stimulation; Other: Exercises

Conservative group

ACTIVE COMPARATOR

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.

Other: Massage therapy; Diagnostic Test: Faradic electrical stimulation; Other: Exercises

Interventions

Neural Mobilisation 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.

Neural Mobilisation Group

Massage therapy OTHER

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

Conservative group; Neural Mobilisation Group

Faradic electrical stimulation 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.

Conservative group; Neural Mobilisation Group

Exercises 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; Neural Mobilisation Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Majmaah University: lead

Study Sites (2)

IAMR

Ghaziabad, Uttar Pradesh, 201206, India

Location

Faizan Kashoo

Meerut, Uttar Pradesh, 15341, India

Location

MeSH Terms

Conditions

Bell Palsy

Interventions

Massage; Exercise

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Mouth Diseases; Stomatognathic Diseases; Facial Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: 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.

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: February 21, 2020
• Study Start: March 1, 2020
• Primary Completion: May 15, 2021
• Study Completion: May 20, 2021
• Last Updated: June 23, 2021

Record last verified: 2021-06

Locations

IN (2)