Pilot Study to Evaluate The Effectiveness And Safety Of Axiom Worldwide Drx9000™ Spinal Decompression System - Full Text View

Sponsored by:	NEMA Research, Inc.
Information provided by:	NEMA Research, Inc.
ClinicalTrials.gov Identifier:	NCT00414596

Purpose

This pilot study will evaluate the effectiveness and safety of the Axiom Worldwide DRX9000 for active treatment of chronic low back pain.

Condition	Intervention
Low Back Pain	Device: DRX9000™

MedlinePlus related topics: Back Pain

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Pilot Study to Evaluate The Effectiveness And Safety Of Axiom Worldwide Drx9000™ Spinal Decompression System For Treatment of Low Back Pain

Further study details as provided by NEMA Research, Inc.:

Study Start Date:	December 2006
Study Completion Date:	April 2007
Primary Completion Date:	April 2007 (Final data collection date for primary outcome measure)

Eligibility

Criteria

Inclusion Criteria:

Male or female, greater than 18 years of age
Able to understand possible risks and benefits and provide written informed consent (ICF) to the IRB approved clinical multimodal protocol
LBP with an intensity level of greater than 4 on an eleven point numerical pain rating scale (VRS) of 0-10 (with 0 - no pain and 10 - worst possible pain)
Completed the necessary diagnostic and medical history evaluations as described in the protocol to confirm the patient's diagnosis and eligibility for the study and DRX9000 treatment protocol.
Willing and able to complete a six week 20 session of DRX9000 outpatient treatments and a minimum of 6 months follow-up

Exclusion Criteria:

Pregnancy
Evidence of neurological motor deficits on clinical examination
Evidence of spinal cord compression, metastatic cancer, tumor, hematoma, infection or compression fracture
Evidence of severe central stenosis with neurological deficits or nerve root entrapment
Litigation for health-related claim (in process or pending), Worker's Compensation, or Personal Injury
Previous spine fusion surgery, insertion of hardware or artificial disc
Hemiplegia or paraplegia
History of severe cardiovascular or metabolic disease, or abdominal aortic aneurysm
Unwillingness to postpone other types of therapy for LBP during the 6 week treatment sessions
Known alcohol abuse or drug abuse
Height less than 4 feet 10 inches (147 cm) or greater than 6 feet 8 inches (203 cm)
Body weight greater than 300 pounds (136 kg)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00414596

Locations

United States, California
Vibrance Medical Group
Beverly Hills, California, United States, 90212
United States, Florida
Active Health and Wellness Center
Tampa, Florida, United States, 33614
Naples Anesthesia and Pain Associates
Naples, Florida, United States, 34108

Sponsors and Collaborators

NEMA Research, Inc.

Investigators

Principal Investigator:	John Leslie, MD	Mayo Clinic Arizona
Study Director:	Charlotte Richmond, PhD	NEMA Research, Inc.
Study Chair:	Joseph V Pergolizzi, MD	Naples Anesthesia and Pain Associates

More Information

click here for more information about the DRX9000 This link exits the ClinicalTrials.gov site

Nema Research website This link exits the ClinicalTrials.gov site

Study ID Numbers:	P-AXW01
Study First Received:	December 19, 2006
Last Updated:	February 14, 2008
ClinicalTrials.gov Identifier:	NCT00414596
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Signs and Symptoms
Neurologic Manifestations
Low Back Pain
Pain
Back Pain

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009