Benign Paroxysmal Positional VertigoNCT00978809
Effects of Physical Treatment on Postural Stability in Benign Paroxysmal Positional Vertigo (BPPV) Patients
A study testing Epley maneuver and Semont maneuver in people with Benign Paroxysmal Positional Vertigo, run by Assuta Hospital Systems at 1 site in Israel.
Trial summary
The propose of this study is to compare two methods of physical treatment for benign paroxysmal positional vertigo, by evaluating treatment effects on postural stability. The trail design is a double blinded randomized controlled trail, with each patient going through three evaluations: before treatment, 1 week after… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Benign Paroxysmal Positional Vertigo
- What is being tested?
- Epley maneuver and Semont maneuver
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2009to Jun 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- medical referral for treating "vertigo"
- subject has short episodes of rotatory vertigo (up to 1 minute)
- subject has positive Hallpike-Dix test with typical nystagmus
- repeated Hallpike-dix test will show fatigability
Who cannot join
- Hallpike-Dix test produces vertigo without nystagmus
- subject has BPPV of the horizontal or anterior semi-circular canal
- subject has other known vestibular or neurologic condition
- subject has nystagmus of a different type
- subject has a cervical spine problem which prevents the utilization of Epley or Semont maneuvers
- subject is unable to stand for 1 minute
- subject gets pharmacologic treatment for vertigo while doing the postural stability evaluation
- subject is under 18 years old or a pregnant female or cannot obtain informed concent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Epley Maneuver vs. Semont Maneuver for Benign Paroxysmal Positional Vertigo (BPPV): Evaluating Treatment Effectiveness by Postural Stability - a Double Blinded Randomized Controlled Trial.
The propose of this study is to compare two methods of physical treatment for benign paroxysmal positional vertigo, by evaluating treatment effects on postural stability.
The trail design is a double blinded randomized controlled trail, with each patient going through three evaluations: before treatment, 1 week after treatment and 60 days after treatment.
- Conditions
- Benign Paroxysmal Positional Vertigo
- Being tested
- Epley maneuver, Semont maneuver
- Keywords
- BPPV, postural stability, Epley, Semont
- 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 maneuverOther
Also called canalith repositioning maneuver
Semont maneuverOther
Also called liberatory manoeuvre
| Study group | Role | What they receive |
|---|---|---|
| Semont | Active comparator | BPPV patients treated by Semont maneuver by a physical therapist. Receives: Other: Semont maneuver |
| control | No intervention | healthy volunteers. |
| Epley maneuver | Active comparator | BPPV patients treated with Epley maneuver by a physical therapist. Receives: Other: Epley maneuver |
What is being measured
The primary outcome is the main question the study is designed to answer.
postural stability
Measured: 60 days post treatment
Secondary outcomes (1)
subjective vertigo
Measured: 60 days post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionJun 2010 (estimated)
- Study completionJun 2010
Why it stopped: major difficulties recruiting patients
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 Benign Paroxysmal Positional 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
- Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assuta Hospital Systems
- Sponsor type
- University, hospital or other
- Collaborators
- Ben-Gurion University of the Negev
- Investigators
- Itshak Melzer, Dr, Study chair, Ben-Gurion University of the NegevMoshe Puterman, Dr, Study director, Soroka University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00978809
- Sponsor's protocol ID
- BPPV-2
- Other IDs
- 2009051
- Status last verified
- Jun 2011
- First submitted
- 16 Sep 2009
- Last updated
- 17 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Blatt PJ, Georgakakis GA, Herdman SJ, Clendaniel RA, Tusa RJ. The effect of the canalith repositioning maneuver on resolving postural instability in patients with benign paroxysmal positional vertigo. Am J Otol. 2000 May;21(3):356-63. doi: 10.1016/s0196-0709(00)80045-9.
PubMed 10821549Di Girolamo S, Paludetti G, Briglia G, Cosenza A, Santarelli R, Di Nardo W. Postural control in benign paroxysmal positional vertigo before and after recovery. Acta Otolaryngol. 1998 Jun;118(3):289-93. doi: 10.1080/00016489850183340.
PubMed 9655200
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epley Maneuver vs. Semont Maneuver for Benign Paroxysmal Positional Vertigo (BPPV): Evaluating Treatment Effectiveness by Postural Stability - a Double Blinded Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT00978809
- Acronym / sponsor ID
- BPPV-2
- Conditions
- Benign Paroxysmal Positional Vertigo
- Keywords
- BPPV, postural stability, Epley, Semont
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: major difficulties recruiting patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assuta Hospital SystemsUniversity, hospital or other
- Collaborators
- Ben-Gurion University of the Negev
- Study start
- Sep 2009
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Jun 2010 (actual)
- First posted
- 17 Sep 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.
The propose of this study is to compare two methods of physical treatment for benign paroxysmal positional vertigo, by evaluating treatment effects on postural stability.
The trail design is a double blinded randomized controlled trail, with each patient going through three evaluations: before treatment, 1 week after treatment and 60 days after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Semont | Active comparator | Other: Semont maneuverBPPV patients treated by Semont maneuver by a physical therapist. |
| control | No intervention | –healthy volunteers. |
| Epley maneuver | Active comparator | Other: Epley maneuverBPPV patients treated with Epley maneuver by a physical therapist. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- medical referral for treating "vertigo"
- subject has short episodes of rotatory vertigo (up to 1 minute)
- subject has positive Hallpike-Dix test with typical nystagmus
- repeated Hallpike-dix test will show fatigability
Key exclusion criteria (8 listed)
- Hallpike-Dix test produces vertigo without nystagmus
- subject has BPPV of the horizontal or anterior semi-circular canal
- subject has other known vestibular or neurologic condition
- subject has nystagmus of a different type
- subject has a cervical spine problem which prevents the utilization of Epley or Semont maneuvers
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 |
|---|---|---|
| Epley maneuverAlso: canalith repositioning maneuver | Other | Epley maneuver |
| Semont maneuverAlso: liberatory manoeuvre | Other | Semont |
Primary outcome
postural stability
Time frame: 60 days post treatment
1 secondary outcome
subjective vertigo
Time frame: 60 days post treatment
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 17 Apr 2015.
- Background: PubMed 10821549Blatt PJ, Georgakakis GA, Herdman SJ, Clendaniel RA, Tusa RJ. The effect of the canalith repositioning maneuver on resolving postural instability in patients with benign paroxysmal positional vertigo. Am J Otol. 2000 May;21(3):356-63. doi: 10.1016/s0196-0709(00)80045-9.
- Background: PubMed 9655200Di Girolamo S, Paludetti G, Briglia G, Cosenza A, Santarelli R, Di Nardo W. Postural control in benign paroxysmal positional vertigo before and after recovery. Acta Otolaryngol. 1998 Jun;118(3):289-93. doi: 10.1080/00016489850183340.
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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.
Itshak Melzer, Dr study chair
Ben-Gurion University of the Negev
Moshe Puterman, Dr study director
Soroka University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epley maneuver and Semont maneuver in people with Benign Paroxysmal Positional Vertigo, run by Assuta Hospital Systems at 1 site in Israel.
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 4 inclusion and 8 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 17 Apr 2015. 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 Israel. 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 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?
postural stability (time frame: 60 days post treatment). 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 NCT00978809, 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 17 Apr 2015.