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Computerized Mobilization of the Cervical Spine Utilizing the Occiflex Device for the Treatment of Chronic Neck Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01216566
Recruitment Status : Unknown
Verified October 2010 by Hillel Yaffe Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : October 7, 2010
Last Update Posted : October 7, 2010
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to investigate the efficacy and safety of the Occiflex device in the treatment of neck pain.

Condition or disease Intervention/treatment Phase
Neck Pain Device: Occiflex Device Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : December 2010
Estimated Primary Completion Date : April 2011
Estimated Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Safety of computerized continuous mobilization of the cervical spine [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Efficacy of computerized mobilization of treatment of patients with chronic neck pain [ Time Frame: one year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: October 7, 2010    Key Record Dates
Last Update Posted: October 7, 2010
Last Verified: October 2010

Additional relevant MeSH terms:
Neck Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms