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

January 22, 2009
January 23, 2009
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Complete list of historical versions of study NCT00828880 on ClinicalTrials.gov Archive Site
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Restoration of Disc Height Reduces Chronic Low Back Pain
Restoration of Disk Height Through Non-Invasive Spinal Decompression is Associated With Decreased Discogenic Low-Back Pain: A Retrospective Cohort Study

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.

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Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Non-Probability Sample

Primary care clinic

Chronic Low Back Pain
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
DRX9000
Intervention: Device: DRX9000
Apfel CC, Cakmakkaya OS, Martin W, Richmond C, Macario A, George E, Schaefer M, Pergolizzi JV. Restoration of disk height through non-surgical spinal decompression is associated with decreased discogenic low back pain: a retrospective cohort study. BMC Musculoskelet Disord. 2010 Jul 8;11:155.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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).

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00828880
R-AXW01
No
Joseph V. Pergolizzi, Jr., MD, NEMA Research, Inc
NEMA Research, Inc.
Axiom Worldwide, LLC
Not Provided
NEMA Research, Inc.
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP