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Benign Paroxysmal Positional VertigoNCT05828433

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

A study testing Epley-Canalith Repositioning and Vestibular Rehabilitation Therapy in people with Benign Paroxysmal Positional Vertigo, run by Dr. Mohammad Abu Shaphe at 1 site in Saudi Arabia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 70 years
Conditions the study is for
Benign Paroxysmal Positional Vertigo
What is being tested?
Epley-Canalith Repositioning and Vestibular Rehabilitation Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteSaudi Arabia
Study dates
7 Jan 2022to 17 Jan 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Saudi Arabia1 site
  • Jazan University

    Jizan

Other trials in Saudi Arabia

About this study

Official title: Effectiveness of Epley-Canalith Repositioning Procedure Versus Vestibular Rehabilitation Therapy in Diabetic Patients With Benign Paroxysmal Positional Vertigo: A Randomized Trial

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).

Read the 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).

Being tested
Epley-Canalith Repositioning, Vestibular Rehabilitation Therapy
Medical subject headings
Benign Paroxysmal Positional Vertigo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Epley-Canalith RepositioningOther

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

  • Vestibular Rehabilitation TherapyOther

    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.

Study groups in NCT05828433
Study groupRoleWhat they receive
Epley-Canalith RepositioningExperimentalStep 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
Receives: Other: Epley-Canalith Repositioning
Vestibular Rehabilitation TherapyExperimentalHabituation exercises Gaze stability exercises and balance training
Receives: Other: Vestibular Rehabilitation Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 4 weeks

  2. 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)

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2023
  2. Study start7 Jan 2022
  3. Primary completion17 Jan 2023
  4. Study completion17 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05828433
Sponsor's protocol ID
04/JUREC/15PT.2022
Status last verified
Apr 2023
First submitted
21 Mar 2023
Last updated
25 Apr 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Epley-Canalith Repositioning and Vestibular Rehabilitation Therapy in people with Benign Paroxysmal Positional Vertigo, run by Dr. Mohammad Abu Shaphe at 1 site in Saudi Arabia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vertigo symptom scale - short form (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.

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