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

October 6, 2010 updated by: Hillel Yaffe Medical Center
The purpose of this study is to investigate the efficacy and safety of the Occiflex device in the treatment of neck pain.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Hadera, Israel, 38100
        • Hillel Yaffe Medical Center
        • Contact:
        • Sub-Investigator:
          • Jill Bracha, PT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: I. Patients with chronic neck pain
Device: Occiflex Device
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety of computerized continuous mobilization of the cervical spine
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy of computerized mobilization of treatment of patients with chronic neck pain
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hillel Yaffe Medical Center

Collaborators

Headway Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (ANTICIPATED)

April 1, 2011

Study Completion (ANTICIPATED)

May 1, 2011

Study Registration Dates

First Submitted

June 1, 2010

First Submitted That Met QC Criteria

October 6, 2010

First Posted (ESTIMATE)

October 7, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

October 7, 2010

Last Update Submitted That Met QC Criteria

October 6, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HYMC-0030-10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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