Computerized Mobilization of the Cervical Spine Utilizing... | NCT01216566

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

NCT01216566

Sponsor

Hillel Yaffe Medical Center

Status

Unknown status

Last Update Posted

Oct 7, 2010Estimated

Enrollment

10Estimated

Phase

Phase 1Phase 2

Conditions

Neck Pain

Interventions

Occiflex Device

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2010

Primary Completion Date

Apr 2011Estimated

Completion Date

May 2011Estimated

First Submitted Date

Jun 1, 2010

First Submission Date that Met QC Criteria

Oct 6, 2010

First Posted Date

Oct 7, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 6, 2010

Last Update Posted Date

Oct 7, 2010Estimated

Name	Class
Headway Ltd.	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to investigate the efficacy and safety of the Occiflex device in the treatment of neck pain.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
I. Patients with chronic neck pain	Experimental		Device: Occiflex Device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Occiflex Device	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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hillel Yaffe Medical Center		Hadera		38100	Israel

Type	Date	Date Unknown
Release	Aug 16, 2011
Reset	Sep 19, 2011
Release	Jul 18, 2012
Reset	Aug 21, 2012
Release	May 7, 2013
Reset	Jun 7, 2013
Release	Aug 22, 2013
Reset	Oct 28, 2013

Submission Tracking

Estimated Results First Submitted Date

Aug 16, 2011

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Aug 16, 2011			Sep 19, 2011
Jul 18, 2012

Condition Browse Module

MeSH Terms

ID	Term
D019547	Neck Pain

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided