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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01518530

First Posted: January 26, 2012

Last Update Posted: October 29, 2013

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.

Information provided by (Responsible Party):

Hillel Yaffe Medical Center

Purpose

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	Intervention	Phase
Neck Pain	Device: Occiflex Robotic Intervention System	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:

MedlinePlus related topics: Neck Injuries and Disorders

U.S. FDA Resources

Further study details as provided by Hillel Yaffe Medical Center:

Primary Outcome Measures:

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:

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.


Enrollment:	10
Study Start Date:	February 2012
Study Completion Date:	May 2012
Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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:

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

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


Responsible Party:	Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:	NCT01518530 History of Changes
Other Study ID Numbers:	0086-11-HYMC
First Submitted:	December 20, 2011
First Posted:	January 26, 2012
Results First Submitted:	May 7, 2013
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

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