VertigoPhase 2NCT00000359
Treatments for Benign Paroxysmal Positional Vertigo (BPPV)
A Phase 2 study testing Canalith repositioning maneuver (Epley maneuver), Semont maneuver and Brandt-Daroff exercises in people with Vertigo, run by Baylor College of Medicine at 1 site in United States.
Trial summary
The purpose of this study was to determine the relative short- and long-term efficacy of several physical treatment paradigms commonly employed for the treatment of benign paroxysmal positional vertigo (BPPV), including the canalith repositioning (Epley) maneuver, the liberatory (Semont) maneuver, the Brandt-Daroff… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Vertigo
- What is being tested?
- Canalith repositioning maneuver (Epley maneuver), Semont maneuver and Brandt-Daroff exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 1998to Jun 2003
- Phase
- Phase 2
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients may be eligible for this study if they:
- Are at least 21 years old.
- Have a diagnosis of unilateral posterior semicircular canal BPPV according to established clinical test criteria.
- Have functional to normal range of motion of the neck and the back.
Who cannot join
- Patients will not be eligible for this study if they:
- Have a history of prior ear surgery or prior treatment for BPPV.
- Have an orthopedic or connective tissue disorder that impairs functional neck or trunk range of motion.
- Have a significant neurological disorder or spinal cord damage.
- Are on vestibular suppressant medications.
- Have Meniere's disease or acoustic neuromas.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study was to determine the relative short- and long-term efficacy of several physical treatment paradigms commonly employed for the treatment of benign paroxysmal positional vertigo (BPPV), including the canalith repositioning (Epley) maneuver, the liberatory (Semont) maneuver, the Brandt-Daroff exercises and nonspecific vestibular habituation exercises. These procedures involve exercises and head manipulations. Vertigo intensity and frequency, the presence/absence of slow-phase eye movements, the degree of dizziness handicap and acts of daily living (ADL) were assessed. The study also ascertained the effects of co-morbid conditions on the response to treatment. While BPPV is a common and significant public health problem that has been recognized for several decades, this is the first systematic study of the relative treatment efficacy of different physical treatment modalities for this disorder.
- Conditions
- Vertigo
- Being tested
- Canalith repositioning maneuver (Epley maneuver), Semont maneuver, Brandt-Daroff exercises, Vestibular habituation exercises, ShamManeuver
- Keywords
- Physical Therapy, Vertigo, rehabilitation, occupational therapy
- Medical subject headings
- Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Canalith repositioning maneuver (Epley maneuver)Behavioural
Also called CRP, Epley maneuver
Standard passive motion of the head: Dix-Hallpike maneuver, turn head to opposite side, roll over, sit up.
Semont maneuverBehavioural
Also called Liberatory maneuver
Sidelying maneuver, flip over 180 deg, sit up.
Brandt-Daroff exercisesBehavioural
Active exercise. Sidelying to involved side, sidelying to uninvolved side, sit up.
Vestibular habituation exercisesBehavioural
Head shaking exercises in pitch, roll, yaw and circumduction. Titrating from 2 repetitions per exercise to 20 repetitions per exercise, as tolerated.
ShamManeuverBehavioural
Passive movement of the head
| Study group | Role | What they receive |
|---|---|---|
| Canalith repositioning maneuver | Experimental | Repositioning treatment for posterior canal BPPV Receives: Behavioral: Canalith repositioning maneuver (Epley maneuver) |
| Modified Epley maneuver | Experimental | Not described Receives: Behavioral: Vestibular habituation exercises |
| Sham | Sham comparator | The subject sat in a chair; the head was passively tilted downward, turned away from the involved side, turned back to center, upward, away from the involved side, twice, slowly. Receives: Behavioral: ShamManeuver |
| Liberatory maneuver | Active comparator | The standard liberatory maneuver (also known as the Semont maneuver) was used. Receives: Behavioral: Semont maneuver |
| Brandt Daroff exercise | Active comparator | Modified Brandt Daroff exercise performed as a self-liberatory exercise. Receives: Behavioral: Brandt-Daroff exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vertigo
Measured: 6 month s
Secondary outcomes (1)
Balance
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 1999 (estimated)
- Study startOct 1998
- Primary completionJun 2003
- Study completionJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for VertigoStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Helen Cohen, Baylor College of Medicine
- Investigators
- Helen Cohen, EdD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000359
- Sponsor's protocol ID
- NIDCD-1156
- Other IDs
- R01DC003602, 1R01DC003602-01A1
- Status last verified
- Jul 2012
- First submitted
- 2 Nov 1999
- Last updated
- 26 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Cohen HS. Side-lying as an alternative to the Dix-Hallpike test of the posterior canal. Otol Neurotol. 2004 Mar;25(2):130-4. doi: 10.1097/00129492-200403000-00008.
PubMed 15021771Cohen HS, Kimball KT, Stewart MG. Benign paroxysmal positional vertigo and comorbid conditions. ORL J Otorhinolaryngol Relat Spec. 2004;66(1):11-5. doi: 10.1159/000077227.
PubMed 15103195Cohen HS, Kimball KT. Treatment variations on the Epley maneuver for benign paroxysmal positional vertigo. Am J Otolaryngol. 2004 Jan-Feb;25(1):33-7. doi: 10.1016/j.amjoto.2003.09.010.
PubMed 15011204Cohen HS, Kimball KT. Effectiveness of treatments for benign paroxysmal positional vertigo of the posterior canal. Otol Neurotol. 2005 Sep;26(5):1034-40. doi: 10.1097/01.mao.0000185044.31276.59.
PubMed 16151355
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatments for Benign Paroxysmal Positional Vertigo (BPPV)
- ClinicalTrials.gov ID
- NCT00000359
- Acronym / sponsor ID
- NIDCD-1156
- Conditions
- Vertigo
- Keywords
- Physical Therapy, Vertigo, rehabilitation, occupational therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- Oct 1998
- Primary completion
- Jun 2003 (actual)
- Study completion
- Jun 2003 (actual)
- First posted
- 3 Nov 1999 (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 purpose of this study was to determine the relative short- and long-term efficacy of several physical treatment paradigms commonly employed for the treatment of benign paroxysmal positional vertigo (BPPV), including the canalith repositioning (Epley) maneuver, the liberatory (Semont) maneuver, the Brandt-Daroff exercises and nonspecific vestibular habituation exercises. These procedures involve exercises and head manipulations. Vertigo intensity and frequency, the presence/absence of slow-phase eye movements, the degree of dizziness handicap and acts of daily living (ADL) were assessed. The study also ascertained the effects of co-morbid conditions on the response to treatment. While BPPV is a common and significant public health problem that has been recognized for several decades, this is the first systematic study of the relative treatment efficacy of different physical treatment modalities for this disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Canalith repositioning maneuver | Experimental | Behavioral: Canalith repositioning maneuver (Epley maneuver)Repositioning treatment for posterior canal BPPV |
| Modified Epley maneuver | Experimental | Behavioral: Vestibular habituation exercises |
| Sham | Sham comparator | Behavioral: ShamManeuverThe subject sat in a chair; the head was passively tilted downward, turned away from the involved side, turned back to center, upward, away from the involved side, twice, slowly. |
| Liberatory maneuver | Active comparator | Behavioral: Semont maneuverThe standard liberatory maneuver (also known as the Semont maneuver) was used. |
| Brandt Daroff exercise | Active comparator | Behavioral: Brandt-Daroff exercisesModified Brandt Daroff exercise performed as a self-liberatory exercise. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Are at least 21 years old.
- Have a diagnosis of unilateral posterior semicircular canal BPPV according to established clinical test criteria.
- Have functional to normal range of motion of the neck and the back.
Key exclusion criteria (6 listed)
- Have a history of prior ear surgery or prior treatment for BPPV.
- Have an orthopedic or connective tissue disorder that impairs functional neck or trunk range of motion.
- Have a significant neurological disorder or spinal cord damage.
- Are on vestibular suppressant medications.
- Have Meniere's disease or acoustic neuromas.
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 |
|---|---|---|
| Canalith repositioning maneuver (Epley maneuver)Also: CRP, Epley maneuverStandard passive motion of the head: Dix-Hallpike maneuver, turn head to opposite side, roll over, sit up. | Behavioural | Canalith repositioning maneuver |
| Semont maneuverAlso: Liberatory maneuverSidelying maneuver, flip over 180 deg, sit up. | Behavioural | Liberatory maneuver |
| Brandt-Daroff exercisesActive exercise. Sidelying to involved side, sidelying to uninvolved side, sit up. | Behavioural | Brandt Daroff exercise |
| Vestibular habituation exercisesHead shaking exercises in pitch, roll, yaw and circumduction. Titrating from 2 repetitions per exercise to 20 repetitions per exercise, as tolerated. | Behavioural | Modified Epley maneuver |
| ShamManeuverPassive movement of the head | Behavioural | Sham |
Primary outcome
Vertigo
Time frame: 6 month s
1 secondary outcome
Balance
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2012.
- Background: PubMed 15021771Cohen HS. Side-lying as an alternative to the Dix-Hallpike test of the posterior canal. Otol Neurotol. 2004 Mar;25(2):130-4. doi: 10.1097/00129492-200403000-00008.
- Results publication: PubMed 15103195Cohen HS, Kimball KT, Stewart MG. Benign paroxysmal positional vertigo and comorbid conditions. ORL J Otorhinolaryngol Relat Spec. 2004;66(1):11-5. doi: 10.1159/000077227.
- Results publication: PubMed 15011204Cohen HS, Kimball KT. Treatment variations on the Epley maneuver for benign paroxysmal positional vertigo. Am J Otolaryngol. 2004 Jan-Feb;25(1):33-7. doi: 10.1016/j.amjoto.2003.09.010.
- Results publication: PubMed 16151355Cohen HS, Kimball KT. Effectiveness of treatments for benign paroxysmal positional vertigo of the posterior canal. Otol Neurotol. 2005 Sep;26(5):1034-40. doi: 10.1097/01.mao.0000185044.31276.59.
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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.
Helen Cohen, EdD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Canalith repositioning maneuver (Epley maneuver), Semont maneuver and Brandt-Daroff exercises in people with Vertigo, run by Baylor College of Medicine at 1 site 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 4 inclusion and 6 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 26 Jul 2012. 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 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 (time frame: 6 month s). 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 NCT00000359, which also lists 4 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 26 Jul 2012.