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

This study is not yet open for participant recruitment.
Verified January 2012 by Hillel Yaffe Medical Center
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT01518530
First received: December 20, 2011
Last updated: January 25, 2012
Last verified: January 2012
History of Changes

December 20, 2011
January 25, 2012
February 2012
May 2012   (final data collection date for primary outcome measure)
Occiflex Device Safety [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT01518530 on ClinicalTrials.gov Archive Site
Efficacy as per the NDI-Neck Disability Index [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
Tailored Computerized Mobilization of the Cervical Spine Utilizing the Occiflex Device for the Treatment of Chronic Neck Pain
Not Provided

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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Neck Pain
Device: Occiflex Robotic Intervention System
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.
  • Active Comparator: Passive Mobilization Cervical Spine
    Intervention: Device: Occiflex Robotic Intervention System
  • Active Comparator: Active + Passive Mobilization Cervical Spine
    Intervention: Device: Occiflex Robotic Intervention System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
30
May 2012
May 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with chronic neck pain: post-whiplash injury, myofacial pain, cervical facet joint disease and idiopathic chronic neck pain

Exclusion Criteria:

  • Patients with cervical radiculopathy Myelopathy Discopathy Malignancy involving the neck or cervical spine Severe Osteoporosis Severe skin disorder Psychiatric disorders Cervical disc herniation
Both
18 Years to 65 Years
No
Contact: Yaron River, MD 972-4-630-4427 yaron60@netvision.net.il
Israel
 
NCT01518530
0086-11-HYMC
Yes
Hillel Yaffe Medical Center
Hillel Yaffe Medical Center
Not Provided
Not Provided
Hillel Yaffe Medical Center
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP