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

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ClinicalTrials.gov Identifier: NCT01518530
Recruitment Status : Completed
First Posted : January 26, 2012
Results First Posted : October 29, 2013
Last Update Posted : October 29, 2013
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center

Study Description
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Brief Summary:
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.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : February 2012
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Passive Mobilization Cervical Spine
Patients with chronic neck pain according to the International Association of the Study of Pain criteria of the following types: facet joint disorder, post-whiplash injury, myofascial pain syndrome.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Occiflex Device Safety [ Time Frame: 6 weeks ]
    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.


Secondary Outcome Measures :
  1. Efficacy as Per the NDI-Neck Disability Index [ Time Frame: 6 weeks ]
    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.


Eligibility Criteria
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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:

  • Patients with cervical radiculopathy Myelopathy Discopathy Malignancy involving the neck or cervical spine Severe Osteoporosis Severe skin disorder Psychiatric disorders Cervical disc herniation
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01518530


Locations
Israel
Hillel Yaffe Medical Center
Hadera, Israel, 38100
Sponsors and Collaborators
Hillel Yaffe Medical Center
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01518530     History of Changes
Other Study ID Numbers: 0086-11-HYMC
First Posted: January 26, 2012    Key Record Dates
Results First Posted: October 29, 2013
Last Update Posted: October 29, 2013
Last Verified: August 2013

Keywords provided by Hillel Yaffe Medical Center:
Chronic Neck Pain, Occiflex, Computerized Mobilization

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