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Restoration of Disc Height Reduces Chronic Low Back Pain

This study has been completed.
Sponsor:
Collaborator:
Axiom Worldwide, LLC
Information provided by:
NEMA Research, Inc.
ClinicalTrials.gov Identifier:
NCT00828880
First received: January 22, 2009
Last updated: January 23, 2009
Last verified: January 2009
History of Changes
  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:

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 by NEMA Research, Inc.

Additional 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
Study First Received: January 22, 2009
Last Updated: January 23, 2009
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 19, 2013