Comparison of EM and SM+ Maneuvers in Patients With BPPV

NCT05853328 | Completed

• 1 other identifier: 20-072
• Study Type: interventional
• Target: 214
• Locations: 3 countries
• Sites: 3

Brief Summary

Objective of this prospective randomized treatment trial is to compare the effectiveness of the SemontPLUS (SM+) with the Epley maneuver (EM) for the therapy of posterior canal benign paroxysmal positional vertigo canalolithiasis (pcBPPV).

Conditions

BPPV

Keywords

Benign paroxysmal positional vertigo; SemontPLUS maneuver; Epley maneuver

Outcome Measures

Primary Outcomes (1)

• Number of days until no positional vertigo could be induced

  Patients had to document whether they could provoke positional vertigo every morning. The primary endpoint was the number of days until no positional vertigo could be induced on three subsequent mornings.

  28 days

Secondary Outcomes (1)

• Effect of the single maneuver performed by the physician.

  28 days

Study Arms (2)

Epley Maneuver

ACTIVE COMPARATOR

The SOC therapy for this patient population is Physical Therapy. No medication or medical device therapy was included. In addition to SOC, patients in this arm were allocated to Epley Maneuver. The first treatment maneuver was performed once by a physician according to the assigned treatment group. The patient simultaneously received verbal instructions on how to perform the maneuver. Fifteen minutes after the first diagnostic maneuver, a second diagnostic maneuver was carried out in order to evaluate the effect of a single maneuver. For the self-maneuvers, patients received written instructions with figures on how to perform the EM independently in a home environment. For the self-maneuver at home, the modified Epley self-maneuver was done by the patient with a pillow under the shoulders. The frequency at home was three times in the morning, three times at noon, and three times in the evening, i.e., nine times per day.

Procedure: Epley Maneuver

SemontPLUS Maneuver

ACTIVE COMPARATOR

The SOC therapy for this patient population is Physical Therapy. No medication or medical device therapy was included. In addition to SOC, patients in this arm were allocated to the SemontPLUS Maneuver. The first treatment maneuver was performed once by a physician according to the assigned treatment group. For the SM+, the angle of the 60° overextended head and body was measured by an inclinometer application. The patient simultaneously received verbal instructions on how to perform the maneuver. Fifteen minutes after the first diagnostic maneuver, a second diagnostic maneuver was carried out in order to evaluate the effect of a single maneuver. For the self-maneuvers, patients received written instructions with figures on how to perform the SM+ independently in a home environment. The frequency at home was three times in the morning, three times at noon, and three times in the evening, i.e., nine times per day.

Procedure: SemontPLUS maneuver

Interventions

Epley Maneuver PROCEDURE

The patient is sitting with both feet on the table or bed with the head looking forward. Subsequently, they let themselves fall backwards with a pillow under the shoulder and the head is turned 45° to the right. They stay in this position for 30 seconds. Afterwards, they turn the head quickly 90° to the left side followed by a turn of the whole body to the left so that their nose is pointing at the floor. They stay in this position for another 30 seconds. Subsequently, the patients sit themselves up with the head still turned 45° to the left. They can help themselves by using both arms. After a few seconds, they can turn the head slowly back to the neutral position facing forward.

Epley Maneuver

SemontPLUS maneuver PROCEDURE

The patients first turn head 45° to the left. Then they extend the right arm and subsequently move the whole body by 150°+ to the right side. This position is kept for 60 seconds. Subsequently, patients move their whole body by 240° towards the non-affected side. Finally, after another 60 seconds, the patient sits up for another 60 sec.

SemontPLUS Maneuver

Eligibility Criteria

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

You may qualify if:

• Subject (≥ 18 years of age) meets diagnostic criteria for the current presence of BPPV of a posterior arcuate duct (8):
• History: rotary vertigo attacks triggered by head or body position change. Duration: \< 1 minute, associated with nausea, vomiting, oscillopsia
• Findings: When positioned to the affected ear: torsional and vertically to the forehead beating, exhaustive nystagmus with crescendo-decrescendo-like course.

You may not qualify if:

• Subjects not capable of giving consent
• Respondent does not want therapy for BPPV

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead

Study Sites (3)

Department of ENT, AZ Sint-Jan Brugge-Oostende AV

Ostend, Flanders, 8400, Belgium

Location

Department of Neurology, Ludwig Maximilian University

Munich, Bavaria, 81377, Germany

Location

Department of ENT, University of Siena

Siena, 53100, Italy

Location

Related Publications (1)

• Strupp M, Mandala M, Vinck AS, Van Breda L, Salerni L, Gerb J, Bayer O, Mavrodiev V, Goldschagg N. The Semont-Plus Maneuver or the Epley Maneuver in Posterior Canal Benign Paroxysmal Positional Vertigo: A Randomized Clinical Study. JAMA Neurol. 2023 Aug 1;80(8):798-804. doi: 10.1001/jamaneurol.2023.1408.

  PMID: 37358870 DERIVED

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 Officials

• Michael Strupp

  LMU University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Model Details: Patients will be randomly assigned to one of two test groups. After being randomized to the SM+ arm or the EM arm, patients will receive one initial maneuver from a physician, then subsequently performe self-maneuvers at home three times in the morning, three times at noon and three times in the evening.

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: May 10, 2023
• Study Start: June 1, 2020
• Primary Completion: March 10, 2022
• Study Completion: April 7, 2022
• Last Updated: May 12, 2023

Record last verified: 2023-05

Locations

BE (1); DE (1); IT (1)