Neck PainPhase 1/2NCT01216566
Computerized Mobilization of the Cervical Spine Utilizing the Occiflex Device for the Treatment of Chronic Neck Pain
A Phase 1/2 study testing Occiflex Device in people with Neck Pain, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to investigate the efficacy and safety of the Occiflex device in the treatment of neck pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Occiflex Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2010to May 2011
- Phase
- Phase 1/2
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chronic neck pain: post-whiplash injury, myofacial pain, cervical facet joint disease and idiopathic chronic neck pain
Who cannot join
- Radiculopathy
- Myelopathy
- Cerebral vascular disease
- Malignancy
- Osteoporosis
- Cervical disc herniation
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hillel Yaffe Medical Center
Hadera, 38100
Yaron M River, MD, 972-4-6304427, yaron60@netvision.net.il
Jill Bracha, PT
About this study
The purpose of this study is to investigate the efficacy and safety of the Occiflex device in the treatment of neck pain.
- Conditions
- Neck Pain
- Being tested
- Occiflex Device
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occiflex DeviceDevice
This device is a computerized robotic platform that allows continuous mobilization of the cervical spine in a three dimensional space. The patients undergoes biweekly 20 minute therapeutic session for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| I. Patients with chronic neck pain | Experimental | Not described Receives: Device: Occiflex Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of computerized continuous mobilization of the cervical spine
Measured: one year
Secondary outcomes (1)
Efficacy of computerized mobilization of treatment of patients with chronic neck pain
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2010 (estimated)
- Study startDec 2010
- Primary completionApr 2011 (estimated)
- Study completionMay 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Collaborators
- Headway Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01216566
- Sponsor's protocol ID
- HYMC-0030-10
- Status last verified
- Oct 2010
- First submitted
- 1 Jun 2010
- Last updated
- 7 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computerized Mobilization of the Cervical Spine Utilizing the Occiflex Device for the Treatment of Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT01216566
- Acronym / sponsor ID
- HYMC-0030-10
- Conditions
- Neck Pain
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Collaborators
- Headway Ltd.
- Study start
- Dec 2010
- Primary completion
- Apr 2011 (estimated)
- Study completion
- May 2011 (estimated)
- First posted
- 7 Oct 2010 (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 is to investigate the efficacy and safety of the Occiflex device in the treatment of neck pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| I. Patients with chronic neck pain | Experimental | Device: Occiflex Device |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with chronic neck pain: post-whiplash injury, myofacial pain, cervical facet joint disease and idiopathic chronic neck pain
Key exclusion criteria (6 listed)
- Radiculopathy
- Myelopathy
- Cerebral vascular disease
- Malignancy
- Osteoporosis
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 |
|---|---|---|
| Occiflex DeviceThis device is a computerized robotic platform that allows continuous mobilization of the cervical spine in a three dimensional space. The patients undergoes biweekly 20 minute therapeutic session for 6 weeks | Device | I. Patients with chronic neck pain |
Primary outcome
Safety of computerized continuous mobilization of the cervical spine
Time frame: one year
1 secondary outcome
Efficacy of computerized mobilization of treatment of patients with chronic neck pain
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2010.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Occiflex Device in people with Neck Pain, run by Hillel Yaffe Medical Center 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 1 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: status not confirmed, as of the sponsor's last update on 7 Oct 2010. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of computerized continuous mobilization of the cervical spine (time frame: one year). 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 7 Oct 2010.