NCT01216566

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2010

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2010

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 7, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

October 7, 2010

Status Verified

October 1, 2010

Enrollment Period

4 months

First QC Date

June 1, 2010

Last Update Submit

October 6, 2010

Conditions

Outcome Measures

Primary Outcomes (1)

  • Safety of computerized continuous mobilization of the cervical spine

    one year

Secondary Outcomes (1)

  • Efficacy of computerized mobilization of treatment of patients with chronic neck pain

    one year

Study Arms (1)

I. Patients with chronic neck pain

EXPERIMENTAL
Device: Occiflex Device

Interventions

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

I. Patients with chronic neck pain

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with chronic neck pain: post-whiplash injury, myofacial pain, cervical facet joint disease and idiopathic chronic neck pain

You may not qualify if:

  • Radiculopathy
  • Myelopathy
  • Cerebral vascular disease
  • Malignancy
  • Osteoporosis
  • Cervical disc herniation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

June 1, 2010

First Posted

October 7, 2010

Study Start

December 1, 2010

Primary Completion

April 1, 2011

Study Completion

May 1, 2011

Last Updated

October 7, 2010

Record last verified: 2010-10

Locations