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Restoration of Disc Height Reduces Chronic Low Back Pain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00828880
First Posted: January 26, 2009
Last Update Posted: January 26, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Axiom Worldwide, LLC
Information provided by:
NEMA Research, Inc.
  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: Observational Model: Cohort
Time Perspective: 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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Joseph V. Pergolizzi, Jr., MD, NEMA Research, Inc
ClinicalTrials.gov Identifier: NCT00828880     History of Changes
Other Study ID Numbers: R-AXW01
First Submitted: January 22, 2009
First Posted: January 26, 2009
Last Update Posted: January 26, 2009
Last Verified: January 2009

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms