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

NEMA Research

Status and phase

Completed

Phase 2

Conditions

Low Back Pain

Treatments

Device: DRX9000™

Study type

Interventional

Funder types

Industry

Identifiers

NCT00414596

P-AXW01

Details and patient eligibility

About

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

Full description

Currently, there are no prospective safety and/or outcomes studies utilizing the DRX9000™ in the peer-reviewed medical literature. There are published trials utilizing similar machines which provided evidence in support of the FDA granted indications for use spinal decompression and of the DRX9000™. Axiom Worldwide has determined it will be of benefit to the continuing medical care of patients and a furthering of the scientific knowledge of the treatment of LBP to complete such a prospective evaluation using a standardized treatment protocol. This study will therefore attempt to establish and validate the safety and efficacy of this computerized spinal decompression system in the treatment of LBP and sciatica.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)