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
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014