Clinical Efficacy and Safety of Axiom Worldwide DRX9000 Axial Decompression System for Treatment of Low Back Pain - Full Text View

Sponsored by:	NEMA Research, Inc.
Information provided by:	NEMA Research, Inc.
ClinicalTrials.gov Identifier:	NCT00469118

Purpose

This study will document efficacy and safety of the Axiom Worldwide DRX9000 for treatment of low back pain (LBP). This study will test the hypothesis that patients with LBP who have undergone a standardized treatment regimen with the DRX9000 will experience greater than 50% reduction in their numerical pain intensity rating scale following completion of a 6 week series of 20 treatments.

Condition	Intervention	Phase
Low Back Pain	Device: DRX9000™	Phase II

MedlinePlus related topics: Back Pain

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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

Primary Outcome Measures:

The primary outcome measure is lower back pain measured on an 11-point numeric rating scale (VRS) with 0 reflecting no pain at all and 10 the worst imaginable pain. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence of adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Recurrence rate, measured by the proportion of patients with VRS ≥ 4 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Proportion of patients using adjuvant analgesic medication [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Functional capacity, measured by the established Oswestry Disability Index [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Patient's satisfaction with procedures and treatment [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:

100

Intervention Details:

Nonsurgical spinal decompression

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

In addition to a diagnosis of LBP, ALL of the following criteria must be met:
- Male or female, >18 years of age
- Able to provide written informed consent (ICF) to the IRB approved clinical multimodal protocol
- Chronic (onset more than 12 weeks) low back pain with an intensity level of > 4 on a verbal rating scale for pain (VRS) of 0-10 (with 0 = no pain and 10 = worst possible pain)
- Completed necessary diagnostic medical history evaluation forms as described in the protocol to confirm the patient's diagnosis and eligibility for the study
- Willing and able to complete the 6 week 20 session DRX9000 outpatient treatments and a minimum of 6 months follow-up

Exclusion Criteria:

If ANY of the following exclusion criteria are present, the subject is NOT eligible:
- Pregnancy
- Evidence of neurologic motor deficits on clinical examination
- Evidence of spinal cord compression, metastatic cancer, tumor, hematoma, infection or compression fracture
- Severe spinal stenosis
- Litigation for health-related claim (in process or pending), Worker's Compensation, or Personal Injury cases
- Previous spine fusion surgery or instrumentation
- Hemiplegia or paraplegia
- Significant cardiovascular or metabolic disease, or abdominal aortic aneurysm
- Unwillingness to postpone other types of therapy for LBP that are not listed as adjuncts in the research protocol
- 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: NCT00469118

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 Pergolizzi, MD	NEMA Research, Inc.

More Information

Responsible Party:	NEMA Research ( Joseph Pergolizzi, MD )
Study ID Numbers:	AXW01
Study First Received:	May 2, 2007
Last Updated:	December 18, 2008
ClinicalTrials.gov Identifier:	NCT00469118
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