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

NCT01518530 | Completed Phase 2 Results DMC

• 1 other identifier: 0086-11-HYMC
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The study is intended to examine the safety and efficacy of computerized mobilization of the neck for the treatment of patients with chronic neck pain. This is a third continuation study aimed at examining the Occiflex Robotic System. This time we will be studying tailored or personalized three dimensional movement of the neck.

Conditions

Neck Pain

Keywords

Chronic Neck Pain, Occiflex, Computerized Mobilization

Outcome Measures

Primary Outcomes (1)

• Occiflex Device Safety

  A meticulous documentation of any serious adverse effect will be made. Any minor side effects will be recorded with an emphasis on the possible relationship to the treatment. The number of minor and serious adverse effects out of 360 therapeutic sessions will be noted.

  6 weeks

Secondary Outcomes (1)

• Efficacy as Per the NDI-Neck Disability Index

  6 weeks

Study Arms (1)

Passive Mobilization Cervical Spine

EXPERIMENTAL

Patients with chronic neck pain according to the International Association of the Study of Pain criteria of the following types: facet joint disorder, post-whiplash injury, myofascial pain syndrome.

Device: Occiflex Robotic Intervention System

Interventions

Occiflex Robotic Intervention System DEVICE

Occiflex is a robotic system which is comprised of a cradle moved in a three dimension space with six degrees of freedom. It allows the therapist to tailor a personalized course of 3-D mobilization of the head and neck.

Passive Mobilization Cervical Spine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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:

• Patients with cervical radiculopathy Myelopathy Discopathy Malignancy involving the neck or cervical spine Severe Osteoporosis Severe skin disorder Psychiatric disorders Cervical disc herniation

Sponsors & Collaborators

• Hillel Yaffe Medical Center: lead

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Yaron River
• Organization: Hillel Yaffe Medical Center

yaronr@hy.health.gov.il

972-523-756-446

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2011
• First Posted: January 26, 2012
• Study Start: February 1, 2012
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: October 29, 2013
• Results First Posted: October 29, 2013

Record last verified: 2013-08

Locations

IL (1)