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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT01518530
First received: December 20, 2011
Last updated: August 22, 2013
Last verified: August 2013
Results First Received: May 7, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Neck Pain
Intervention: Device: Occiflex Robotic Intervention System

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
From January 2012 to February 2012 twenty-three patients were screened and 10 were found to be eligible in the Physical Therapy Department of the Hillel Yaffe Medical Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One recruited patient was dropped because of protocol violation.

Reporting Groups
  Description
Chronic Neck Pain Patients Treated With Occiflex Occiflex is a computerized robotic system for the accurate 3-dimensional mobilization of the head and neck.

Participant Flow for 2 periods

Period 1:   Active Treatment Period
    Chronic Neck Pain Patients Treated With Occiflex  
STARTED     10  
COMPLETED     9  
NOT COMPLETED     1  

Period 2:   Post-Treatment Follow-up
    Chronic Neck Pain Patients Treated With Occiflex  
STARTED     9  
COMPLETED     9  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
One patient dropped out of the experiment due to lack of necessary documentation required for inclusion.

Reporting Groups
  Description
Patients With Chronic Neck Pain Treated With Occiflex Occiflex is a computerized robotic system for the accurate 3-dimensional mobilization of the head and neck.

Baseline Measures
    Patients With Chronic Neck Pain Treated With Occiflex  
Number of Participants  
[units: participants]
  9  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     9  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  47  ± 11.21  
Gender  
[units: participants]
 
Female     7  
Male     2  
Region of Enrollment  
[units: participants]
 
Israel     10  



  Outcome Measures

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

2.  Secondary:   Efficacy as Per the NDI-Neck Disability Index   [ Time Frame: 6 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Yaron River
Organization: Hillel Yaffe Medical Center
phone: 972-523-756-446
e-mail: yaronr@hy.health.gov.il


No publications provided


Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01518530     History of Changes
Other Study ID Numbers: 0086-11-HYMC
Study First Received: December 20, 2011
Results First Received: May 7, 2013
Last Updated: August 22, 2013
Health Authority: Israel: Ministry of Health