Restoration of Disc Height Reduces Chronic Low Back Pain

This study has been completed.

First Received: January 22, 2009 Last Updated: January 23, 2009 History of Changes

Sponsors and Collaborators:	NEMA Research, Inc. Axiom Worldwide, LLC
Information provided by:	NEMA Research, Inc.
ClinicalTrials.gov Identifier:	NCT00828880

Purpose

The investigators hypothesize that a 6-week treatment of non-invasive spinal decompression reduces discogenic low back pain (LBP), increases lumbar disk height, and that an increase in lumbar disc height is associated with decreased LBP.

Condition	Intervention
Chronic Low Back Pain	Device: DRX9000

Study Type:	Observational
Study Design:	Cohort, Retrospective
Official Title:	Restoration of Disk Height Through Non-Invasive Spinal Decompression is Associated With Decreased Discogenic Low-Back Pain: A Retrospective Cohort Study

Resource links provided by NLM:

MedlinePlus related topics: Back Pain

U.S. FDA Resources

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

Groups/Cohorts	Assigned Interventions
DRX9000	Device: DRX9000 DRX9000 - non-invasive spinal decompression. Treatments 28 min 5 x/wk x 2wks, 3x/wk x 2 wks, 2x/wk x 2 wks for a total of 20 treatments in a 6-week period

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Primary care clinic

Criteria

Inclusion Criteria:

at least 18 years of age;
consented for the 6 weeks treatment protocol;
presented with discogenic low back pain of at least 3 out of 10; AND
current CT scan not older than 2 months.

Exclusion Criteria:

metastatic cancer;
previous spinal fusion or placement of stabilization hardware;
instrumentation or artificial discs;
neurologic motor deficits, bladder, or sexual dysfunction;
alcohol or drug abuse; OR
litigation for a health-related claim (in process or pending for workers' compensation or personal injury).

Limitations of the spinal decompression system also led to the exclusion of patients with extremes of height (< 147 cm or > 203 cm) and body weight (> 136 kg).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00828880

Locations

United States, Texas
Upper Valley Interventional Radiology
McAllen, Texas, United States, 78501

Sponsors and Collaborators

NEMA Research, Inc.

Axiom Worldwide, LLC

More Information

No publications provided

Responsible Party:	NEMA Research, Inc ( Joseph V. Pergolizzi, Jr., MD )
Study ID Numbers:	R-AXW01
Study First Received:	January 22, 2009
Last Updated:	January 23, 2009
ClinicalTrials.gov Identifier:	NCT00828880 History of Changes
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:

Signs and Symptoms
Nervous System Diseases
Neurologic Manifestations

Low Back Pain
Pain
Back Pain

ClinicalTrials.gov processed this record on September 10, 2009