VertigoLM_BPPVNCT01008124
The Liberatory Maneuver for the Treatment of Benign Paroxysmal Positional Vertigo (BPPV)
A study testing Liberatory Maneuver in people with Vertigo and Vestibular Disease, run by Midwestern University at 2 sites in United States.
Trial summary
This study is being done because the investigators would like to know how effective the Liberatory maneuver is in treating benign paroxysmal positional vertigo (BPPV). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vertigo, Vestibular Disease
- What is being tested?
- Liberatory Maneuver
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2009to Nov 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BPPV involving the posterior canal on only one side
Who cannot join
- No other canals involved (anterior canal or lateral canal), no central nervous system disorder, and no other medical condition that would not enable the individual to have the maneuver done.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Chicago Dizziness and Hearing
Chicago, Illinois, 60611
Midwestern University
Downers Grove, Illinois, 60515
About this study
Official title: The Liberatory Maneuver for the Treatment of Benign Paroxysmal Positional Vertigo: A Randomized Controlled Trial
This study is being done because the investigators would like to know how effective the Liberatory maneuver is in treating benign paroxysmal positional vertigo (BPPV).
Read the detailed description
BPPV is a problem with the inner ear that causes brief periods of vertigo triggered by changes in the position of the head such as rolling, looking up, or bending down. BPPV is presently thought to be caused by small pieces of debris or crystals becoming displaced within the inner ear. It can be treated by moving the patient through a series of positions called a maneuver. There are 2 different maneuvers currently used to treat BPPV by the clinician called the liberatory maneuver and the canalith repositioning procedure. We would like to determine how effective the liberatory maneuver is in the treatment of BPPV compared to a placebo maneuver.
- Conditions
- Vertigo, Vestibular Disease
- Being tested
- Liberatory Maneuver, Placebo maneuver
- Keywords
- Benign Paroxysmal Positional Vertigo, BPPV, PC, BPPN, Vertigo
- Medical subject headings
- Vertigo, Vestibular Diseases, Benign Paroxysmal Positional Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liberatory ManeuverOther
Also called Semont Maneuver
3 cycles of the liberatory maneuver initial session.
Placebo maneuverOther
3 cycles placebo maneuver initial session.
| Study group | Role | What they receive |
|---|---|---|
| Liberatory Maneuver | Experimental | Liberatory Maneuver Receives: Other: Liberatory Maneuver |
| Placebo Maneuver | Placebo comparator | Placebo Maneuver Receives: Other: Placebo maneuver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative Dix-Hallpike maneuver
Measured: 1-2 weeks
Secondary outcomes (1)
Self reported willingness to move
Measured: 1-2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2009 (estimated)
- Study startNov 2009 (estimated)
- Primary completionNov 2010 (estimated)
- Study completionNov 2010 (estimated)
Why it stopped: Never recruited/started study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for VertigoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Midwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University
- Responsible party
- Principal investigator, Janet Odry Helminski, PhD, Midwestern University
- Investigators
- Janet O. Helminski, PhD, Principal investigator, Midwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01008124
- Sponsor's protocol ID
- MWU 1718
- Acronym
- LM_BPPV
- Status last verified
- Mar 2021
- First submitted
- 4 Nov 2009
- Last updated
- 29 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Salvinelli F, Trivelli M, Casale M, Firrisi L, Di Peco V, D'Ascanio L, Greco F, Miele A, Petitti T, Bernabei R. Treatment of benign positional vertigo in the elderly: a randomized trial. Laryngoscope. 2004 May;114(5):827-31. doi: 10.1097/00005537-200405000-00007.
PubMed 15126738Massoud EA, Ireland DJ. Post-treatment instructions in the nonsurgical management of benign paroxysmal positional vertigo. J Otolaryngol. 1996 Apr;25(2):121-5.
PubMed 8683652
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Liberatory Maneuver for the Treatment of Benign Paroxysmal Positional Vertigo: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01008124
- Acronym / sponsor ID
- LM_BPPV / MWU 1718
- Conditions
- Vertigo, Vestibular Disease
- Keywords
- Benign Paroxysmal Positional Vertigo, BPPV, PC, BPPN, Vertigo
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Never recruited/started study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Midwestern UniversityUniversity, hospital or other
- Collaborators
- Northwestern University
- Study start
- Nov 2009 (estimated)
- Primary completion
- Nov 2010 (estimated)
- Study completion
- Nov 2010 (estimated)
- First posted
- 5 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done because the investigators would like to know how effective the Liberatory maneuver is in treating benign paroxysmal positional vertigo (BPPV).
Detailed description
BPPV is a problem with the inner ear that causes brief periods of vertigo triggered by changes in the position of the head such as rolling, looking up, or bending down. BPPV is presently thought to be caused by small pieces of debris or crystals becoming displaced within the inner ear. It can be treated by moving the patient through a series of positions called a maneuver. There are 2 different maneuvers currently used to treat BPPV by the clinician called the liberatory maneuver and the canalith repositioning procedure. We would like to determine how effective the liberatory maneuver is in the treatment of BPPV compared to a placebo maneuver.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liberatory Maneuver | Experimental | Other: Liberatory ManeuverLiberatory Maneuver |
| Placebo Maneuver | Placebo comparator | Other: Placebo maneuverPlacebo Maneuver |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BPPV involving the posterior canal on only one side
Key exclusion criteria (1 listed)
- No other canals involved (anterior canal or lateral canal), no central nervous system disorder, and no other medical condition that would not enable the individual to have the maneuver done.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liberatory ManeuverAlso: Semont Maneuver3 cycles of the liberatory maneuver initial session. | Other | Liberatory Maneuver |
| Placebo maneuver3 cycles placebo maneuver initial session. | Other | Placebo Maneuver |
Primary outcome
Negative Dix-Hallpike maneuver
Time frame: 1-2 weeks
1 secondary outcome
Self reported willingness to move
Time frame: 1-2 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2021.
- Background: PubMed 15126738Salvinelli F, Trivelli M, Casale M, Firrisi L, Di Peco V, D'Ascanio L, Greco F, Miele A, Petitti T, Bernabei R. Treatment of benign positional vertigo in the elderly: a randomized trial. Laryngoscope. 2004 May;114(5):827-31. doi: 10.1097/00005537-200405000-00007.
- Background: PubMed 8683652Massoud EA, Ireland DJ. Post-treatment instructions in the nonsurgical management of benign paroxysmal positional vertigo. J Otolaryngol. 1996 Apr;25(2):121-5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janet O. Helminski, PhD principal investigator
Midwestern University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liberatory Maneuver in people with Vertigo and Vestibular Disease, run by Midwestern University at 2 sites in United States.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 29 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Negative Dix-Hallpike maneuver (time frame: 1-2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01008124, which also lists 2 linked publications.
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 29 Mar 2021.