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NCT00414596 Clinical Trial

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

Low Back Pain Clinical Trial

Official title:
Pilot Study to Evaluate The Effectiveness And Safety Of Axiom Worldwide Drx9000™ Spinal Decompression System For Treatment of Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00414596
Other study ID # P-AXW01
Secondary ID
Status Completed
Phase N/A
First received December 19, 2006
Last updated February 12, 2009
Start date December 2006
Est. completion date April 2007

Study information
Verified date February 2009
Source NEMA Research, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date April 2007
Est. primary completion date April 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• DRX9000™

Locations
Country Name City State
United States Vibrance Medical Group Beverly Hills California
United States Naples Anesthesia and Pain Associates Naples Florida
United States Active Health and Wellness Center Tampa Florida

Sponsors (1)
Lead Sponsor Collaborator
NEMA Research, Inc.

Country where clinical trial is conducted

United States, 

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