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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. The completion date has passed and the status has not been verified in more than two years.
Verified October 2010 by Hillel Yaffe Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01216566
First Posted: October 7, 2010
Last Update Posted: October 12, 2017
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.
Collaborator:
Headway Ltd.
Information provided by:
Hillel Yaffe Medical Center
  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
Intervention Model: Single Group Assignment
Masking: None (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 ]

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

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

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 Submitted: June 1, 2010
First Posted: October 7, 2010
Last Update Posted: October 12, 2017
Last Verified: October 2010

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