Effect of Epley-Canalith Repositioning Procedure and Vestibular Rehabilitation Therapy in Diabetic Patients With BPPV

NCT05828433 | Completed

• 1 other identifier: 04/JUREC/15PT.2022
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Benign paroxysmal positional vertigo (BPPV) is a common inner ear disorder characterized by brief episodes of vertigo caused by changes in head position. The condition can cause significant func-tional impairment and reduced quality of life. BPPV is especially common among diabetic patients. The Epley-Canalith Repositioning Procedure (CRP) and Vestibular Rehabilitation Therapy (VRT) are two commonly used interventions for the treatment of BPPV. The objective of this paper is to determine the effective therapy among Epley-Canalith Repositioning Procedure and Vestibular Rehabilitation for improving balance and posture control in Diabetic patients with Benign Parox-ysmal Positional Vertigo. Thirty subjects with Diabetes Mellitus (Type 2) suffering from Benign Paroxysmal Positional Vertigo (BPPV) were recruited for the study and randomly assigned to groups A and B, underwent Canalith Repositioning Procedure and Vestibular Rehabilitation Therapy respectively. The outcome measures of the study were Vertigo Symptom Scale- Short Form (VSS-sf) score and Berg Balance Scale Form (BBS) score assessed at pre -treatment (pre) and 4 weeks post treatment (post).

Conditions

Benign Paroxysmal Positional Vertigo

Outcome Measures

Primary Outcomes (2)

• Vertigo symptom scale - short form

  VSS consisting of 36 items addresses frequency and severity of dizziness symptoms within the last 12 months. Both a long (VSS-lf) and short a form (VSS-sf) is available. There are 15 items in the VSS-sf. The VSS-sf exhibits high internal consistency (alpha=0.9) and r=0.52 is the construct validity. It has high test -retest reliability is ICC VSS-sf = 0.88, VSS-V=0.90, VSS-A=0.90

  4 weeks

• Berg Balance Scale

  It is used to test if a patient can securely balance himself while doing a series of prede-termined tasks. It consists of 14 items, each of which has a 5-point ordinal scale rang-ing from 0 to 4, with 0 denoting the lowest degree of function and 4 denoting the high-est level. The relative intra-rater reliability of the BBS with a pooled estimate of 0.98 (95% CI 0.97 to 0.99). Relative inter-rater reliability of the BBS with a pooled estimate of 0.97 (95% CI 0.96 to 0.98)

  4 weeks

Study Arms (2)

Epley-Canalith Repositioning

EXPERIMENTAL

Step 1: The patient was brought down with the head tilted 45 degrees towards the af-fected canal as in Hallpike test. The neck was extended. Step 2: The head was rotated 90 degrees towards the unaffected side. The neck was extended. Step 3: The head and body were rotated by further 90 degrees from the previous positions (now face down). The neck was in neutral position. Step 4: The patient was brought into a sitting position while having their head turned constantly in the direction of the unaffected side. Step 5: The head was turn forward and the chin was kept 20° down for a minute

Other: Epley-Canalith Repositioning

Vestibular Rehabilitation Therapy

EXPERIMENTAL

Habituation exercises Gaze stability exercises and balance training

Other: Vestibular Rehabilitation Therapy

Interventions

Epley-Canalith Repositioning OTHER

Epley-Canalith Repositioning The intervention was given for approximately 15min, for 2 times in a week, for 4 weeks.

Epley-Canalith Repositioning

Vestibular Rehabilitation Therapy OTHER

Vestibular Rehabilitation Therapy Habituation exercises: The patients were asked to repeat the exercises 5 -10 times for 5 to 10 min, for 2 days in a week, for 4 weeks. Gaze stability exercises and balance training: The exercises were performed in 3 sets or 5 repetitions, for 2 days in a week, for 4 weeks.

Vestibular Rehabilitation Therapy

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are diagnosed with posterior canal BPPV by ENT physician
• Patients diagnosed with diabetes mellitus (Type 2) by the physician through laboratory investigations
• Both male and female
• Age between 20 to 70 years
• Positive Dix -Hallpike test
• Nystagmus lasting less than 60 seconds
• Willing to participate in the study
• Minimum score of 25/56 in Berg Balance Scale

You may not qualify if:

• Patients taking antivertigo drugs
• Treated for similar vertigo experience
• Disease of different origin that may cause vertigo like migraine, multiple sclerosis, stroke, traumatic brain injury
• CRP has been done before
• Other causes of peripheral vertigo such as Meniere's disease, vestibular neuritis, labyrinthitis and peri lymphatic fistula
• Pathologies contraindicated for Dix- Hallpike manoeuvre like prolapse inter-vertebral disk, cervical spine instability, cervical myelopathy
• Previous cervical spine surgery

Sponsors & Collaborators

• Dr. Mohammad Abu Shaphe: lead

Study Sites (1)

Jazan University

Jizan, Saudi Arabia

Location

MeSH Terms

Conditions

Benign Paroxysmal Positional Vertigo

Condition Hierarchy (Ancestors)

Vertigo; Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: April 25, 2023
• Study Start: January 7, 2022
• Primary Completion: January 17, 2023
• Study Completion: January 17, 2023
• Last Updated: April 25, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)