Neck PainPhase 2NCT01518530
Tailored Computerized Mobilization of the Cervical Spine Utilizing the Occiflex Device for the Treatment of Chronic Neck Pain
A Phase 2 study testing Occiflex Robotic Intervention System in people with Neck Pain, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
The study is intended to examine the safety and efficacy of computerized mobilization of the neck for the treatment of patients with chronic neck pain. This is a third continuation study aimed at examining the Occiflex Robotic System. 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 Robotic Intervention System
- 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
- Feb 2012to May 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients with cervical radiculopathy Myelopathy Discopathy Malignancy involving the neck or cervical spine Severe Osteoporosis Severe skin disorder Psychiatric disorders Cervical disc herniation
Trial locations and contacts
1 site in 1 country.
About this study
The study is intended to examine the safety and efficacy of computerized mobilization of the neck for the treatment of patients with chronic neck pain. This is a third continuation study aimed at examining the Occiflex Robotic System. This time we will be studying tailored or personalized three dimensional movement of the neck.
- Conditions
- Neck Pain
- Being tested
- Occiflex Robotic Intervention System
- Keywords
- Chronic Neck Pain, Occiflex, Computerized Mobilization
- 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 Robotic Intervention SystemDevice
Occiflex is a robotic system which is comprised of a cradle moved in a three dimension space with six degrees of freedom. It allows the therapist to tailor a personalized course of 3-D mobilization of the head and neck.
| Study group | Role | What they receive |
|---|---|---|
| Passive Mobilization Cervical Spine | Experimental | Patients with chronic neck pain according to the International Association of the Study of Pain criteria of the following types: facet joint disorder, post-whiplash injury, myofascial pain syndrome. Receives: Device: Occiflex Robotic Intervention System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occiflex Device Safety
A meticulous documentation of any serious adverse effect will be made. Any minor side effects will be recorded with an emphasis on the possible relationship to the treatment. The number of minor and serious adverse effects out of 360 therapeutic sessions will be noted.
Measured: 6 weeks
Secondary outcomes (1)
Efficacy as Per the NDI-Neck Disability Index
The most important instrument used to measure efficacy of treatment in patients with chronic neck pain will be used. A score of 0-50, where 50 denotes maximal disability due to chronic neck pain will be documented.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2012 (estimated)
- Study startFeb 2012
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01518530
- Sponsor's protocol ID
- 0086-11-HYMC
- Status last verified
- Aug 2013
- First submitted
- 20 Dec 2011
- Last updated
- 29 Oct 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored Computerized Mobilization of the Cervical Spine Utilizing the Occiflex Device for the Treatment of Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT01518530
- Acronym / sponsor ID
- 0086-11-HYMC
- Conditions
- Neck Pain
- Keywords
- Chronic Neck Pain, Occiflex, Computerized Mobilization
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Feb 2012
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 26 Jan 2012 (estimated)
- Results
- Posted 29 Oct 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is intended to examine the safety and efficacy of computerized mobilization of the neck for the treatment of patients with chronic neck pain. This is a third continuation study aimed at examining the Occiflex Robotic System. This time we will be studying tailored or personalized three dimensional movement of the neck.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Passive Mobilization Cervical Spine | Experimental | Device: Occiflex Robotic Intervention SystemPatients with chronic neck pain according to the International Association of the Study of Pain criteria of the following types: facet joint disorder, post-whiplash injury, myofascial pain syndrome. |
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 (1 listed)
- Patients with cervical radiculopathy Myelopathy Discopathy Malignancy involving the neck or cervical spine Severe Osteoporosis Severe skin disorder Psychiatric disorders Cervical disc herniation
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 Robotic Intervention SystemOcciflex is a robotic system which is comprised of a cradle moved in a three dimension space with six degrees of freedom. It allows the therapist to tailor a personalized course of 3-D mobilization of the head and neck. | Device | Passive Mobilization Cervical Spine |
Primary outcome
Occiflex Device Safety
Time frame: 6 weeks
A meticulous documentation of any serious adverse effect will be made. Any minor side effects will be recorded with an emphasis on the possible relationship to the treatment. The number of minor and serious adverse effects out of 360 therapeutic sessions will be noted.
1 secondary outcome
Efficacy as Per the NDI-Neck Disability Index
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Occiflex Robotic Intervention System 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 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: finished, as of the sponsor's last update on 29 Oct 2013. 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 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?
Yes. Results are posted in the registry (first posted 29 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Occiflex Device Safety (time frame: 6 weeks). 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 29 Oct 2013.