Computerized Mobilization of the Cervical Spine Utilizing the Occiflex Device for the Treatment of Chronic Neck Pain
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Hillel Yaffe Medical Center.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Hillel Yaffe Medical Center
Collaborator:
Headway Ltd.
Information provided by:
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT01216566
First received: June 1, 2010
Last updated: October 6, 2010
Last verified: October 2010
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Purpose
The purpose of this study is to investigate the efficacy and safety of the Occiflex device in the treatment of neck pain.
| Condition | Intervention | Phase |
|---|---|---|
|
Neck Pain |
Device: Occiflex Device |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Hillel Yaffe Medical Center:
Primary Outcome Measures:
- Safety of computerized continuous mobilization of the cervical spine [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Efficacy of computerized mobilization of treatment of patients with chronic neck pain [ Time Frame: one year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 10 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | May 2011 |
| Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: I. Patients with chronic neck pain |
Device: Occiflex Device
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with chronic neck pain: post-whiplash injury, myofacial pain, cervical facet joint disease and idiopathic chronic neck pain
Exclusion Criteria:
- Radiculopathy
- Myelopathy
- Cerebral vascular disease
- Malignancy
- Osteoporosis
- Cervical disc herniation
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01216566
Locations
| Israel | |
| Hillel Yaffe Medical Center | Not yet recruiting |
| Hadera, Israel, 38100 | |
| Contact: Yaron M River, MD 972-4-6304427 yaron60@netvision.net.il | |
| Sub-Investigator: Jill Bracha, PT | |
Sponsors and Collaborators
Hillel Yaffe Medical Center
Headway Ltd.
More Information
No publications provided
| Responsible Party: | Yaron River, MD, Dept. of Neurology, Hillel Yaffe Medical Center |
| ClinicalTrials.gov Identifier: | NCT01216566 History of Changes |
| Other Study ID Numbers: | HYMC-0030-10 |
| Study First Received: | June 1, 2010 |
| Last Updated: | October 6, 2010 |
| Health Authority: | Israel: Ministry of Health |
Additional relevant MeSH terms:
|
Neck Pain Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013