Back to resultsComputerized Mobilization of the Cervical Spine Utilizing the Occiflex Device for the Treatment of Chronic Neck Pain
Primary Purpose
Neck Pain
Status
Unknown status
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Occiflex Device
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pain
Eligibility 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
Sites / Locations
- Hillel Yaffe Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
I. Patients with chronic neck pain
Arm Description
Outcomes
Primary Outcome Measures
Safety of computerized continuous mobilization of the cervical spine
Secondary Outcome Measures
Efficacy of computerized mobilization of treatment of patients with chronic neck pain
Full Information
NCT ID
NCT01216566
First Posted
June 1, 2010
Last Updated
October 6, 2010
Sponsor
Hillel Yaffe Medical Center
Collaborators
Headway Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01216566
Brief Title
Computerized Mobilization of the Cervical Spine Utilizing the Occiflex Device for the Treatment of Chronic Neck Pain
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Unknown status
Study Start Date
December 2010 (undefined)
Primary Completion Date
April 2011 (Anticipated)
Study Completion Date
May 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Hillel Yaffe Medical Center
Collaborators
Headway Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to investigate the efficacy and safety of the Occiflex device in the treatment of neck pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
I. Patients with chronic neck pain
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Occiflex Device
Intervention Description
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
Primary Outcome Measure Information:
Title
Safety of computerized continuous mobilization of the cervical spine
Time Frame
one year
Secondary Outcome Measure Information:
Title
Efficacy of computerized mobilization of treatment of patients with chronic neck pain
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Hillel Yaffe Medical Center
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yaron M River, MD
Phone
972-4-6304427
Email
yaron60@netvision.net.il
First Name & Middle Initial & Last Name & Degree
Jill Bracha, PT
12. IPD Sharing Statement
Learn more about this trial
Computerized Mobilization of the Cervical Spine Utilizing the Occiflex Device for the Treatment of Chronic Neck Pain
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