Clinical trial NCT05828433: Effect of Epley-Canalith Repositioning Procedure and Vestibular Rehabilitation Therapy in Diabetic Patients With BPPV
Official title: Effectiveness of Epley-Canalith Repositioning Procedure Versus Vestibular Rehabilitation Therapy in Diabetic Patients With Benign Paroxysmal Positional Vertigo: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Paroxysmal Positional Vertigo
Lead sponsor: University of Jazan
Sponsor class: OTHER_GOV
First posted: 2023-04-25
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed description: Research Objectives:To determine the effective therapy among Epley-Canalith Repositioning Procedure and Vestibular Rehabilitation for improving balance and posture control in Diabetic patients with Benign Paroxysmal Positional Vertigo

Methods: Thirty subjects were recruited for the proposed study on the basis of inclusion and exclusion criteria. Patients who are diagnosed with posterior canal BPPV by ENT physician and diabetes by the physician through laboratory investigations, both male and female aged between 20 to 70 years, Positive Dix -Hallpike test, Nystagmus lasting less than 60 seconds, willing to participate in the study and with a minimum score of 25/56 in Berg Balance Scale were included. Whereas, patients taking antivertigo drugs, who had been treated for similar vertigo experience, disease of different origin that may cause vertigo like migraine, multiple sclerosis, stroke, traumatic brain injury, if CRP has been done before, other causes of peripheral vertigo such as Meniere's disease, vestibular neuritis, labrynthitis and perilymphatic fistula, pathologies contraindicated for Dix- hallpike maneuver like prolapse intervertebral disk, cervical spine instability, cervical myelopathy, previous cervical spine surgery were excluded. Those meeting the criteria will be randomized into Group A i.e., Epley-Canalith Repositioning and Group B i.e., Vestibular Rehabilitation Therapy through lottery method.

Interventions In Group A (control group), the affected posterior canal (it is the posterior semi-circular canal of the under most ear when the classic nystagmus is provoked) was predetermined by Dix-Hallpike test. The time of latency and duration of induced nystagmus was recorded by an assistant using stopwatch. This provided an estimate of the time required for the canalith bolus trough 90°.

Procedure will be explained to the patients before the intervention. The patients will be asked to keep the eyes open to watch the nystagmus. The patient will be seated length wise on the examination table in search a way that when brought to the Hallpike position, the head should extend beyond the end of the table. An assistant was asked to stand by the side of affected canal.

Step 1: The patient was brought down with the head turned 45° towards the affected canal as in Hallpike test. The neck was extended.

Step 2: The head was rotated 90° towards the unaffected side. The neck will be extended Step 3: The head and body was rotated by further 9°0 from the previous positions (now face down). The neck was in neutral position. Step 4: The patient was brought up in siting position while the head was kept turning towards the unaffected side. Step 5: The head was turned forward and the chin will be kept 20° down for a minute.

Since all the patients were having nystagmus lasting for less than 60 seconds, each position was maintained for 60 second. The procedure will be repeated until no nystagmus will be observed during the last cycle or until no progress is apparent in the last two cycles.

The intervention will be given for approximately 15min, for 2 times in a week, for 4 weeks.

Before going home, all the patients were given instructions:

* The patients were asked to wait for 10 minutes after the maneuver is performed before going home
* Patients were instructed not to lie supine, to keep their head at 45 reclining positions while sleeping for 2 days.
* All patients were asked to avoid provoking head positions like bending over, looking up or down for 7 days following the procedure.

Group B received Vestibular Rehabilitation Therapy which consisted of habituation exercises, gaze stability and balance training. Habituation exercises: The patient were instructed to sit on the side the examining couch. Then he was warned that the exercises could worsen the frequency and intensity of vertigo in the beginning but that they should not alarmed because the symptoms would subside with the continuation of the intervention. In this testing, each maneuver is done in a passive way. For each measurement, it was noted whether vertigo is elicited (M+ or M-). Intensity and duration of vertigo will be recorded. When nystagmus is observed, its presence or absence is noted (Ny+ or Ny-). In case of exacerbation of symptoms, the exercises will be modified by decreasing the repetition or stopping the exercises until the symptoms disappeared. The frequency and duration of the exercises will be customized according the patient's response to the exercises. In this study, 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. The exercises program were be graded so that the patient progresses from easily tolerated movements to difficult ones. Gaze stability exercises and balance training: The exercises were progressed from sitting to standing and support surface conditions were systematically varied progressing from firm surface to compliant and regular surfaces. The exercises were performed in 3 sets or 5 repetitions, for 2 days in a week, for 4 weeks. Data collection In this study, 30 subjects who fulfilled the inclusion criteria were included. Those meeting the criteria met with the physiotherapist who explained the project. Subjects were provided with the general guidance and information about the project and given time to consider involvement. The subjects will be given further opportunity to ask questions and then they will give a consent form.

After giving consent, patients were assessed with Dix- hallpike, Vertigo Symptom Scale -sf, Berg Balance Scale before the intervention and the findings will be recorded. The patients will be divided into 2 groups, Group A (N =15) and Group B (N=15). All the outcome were again recoded after the 4 weeks of intervention.

Data analysis Data was summarized as Mean ± SE (standard error of the mean). Pre and post groups were compared by paired t test. Pre to post change (pre-post or post-pre) in outcome measures of two independent groups will be compared by independent Student's t test. Discrete (categorical) data were summarized in number (n) and percentage (%) and compared by chi-square (χ2) test. A two-tailed (α=2) p\<0.05 will be considered statistically significant. Analyses was performed on SPSS software (Windows version 17.0).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Vertigo symptom scale - short form
timeFrame: 4 weeks
measure: Berg Balance Scale
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jazan
country: Saudi Arabia
facility: Jazan University
Study officials:
References: