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OpenTrials
Completed

NCT Number: NCT00828880

Restoration of Disc Height Reduces Chronic Low Back Pain

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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Key information

Conditions

Chronic Low Back Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Upper Valley Interventional Radiology

McAllen, Texas, 78501, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

DRX9000

Device

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

Sponsors and collaborators

Lead sponsor

NEMA Research, Inc.

Industry

Collaborators

  • Axiom Worldwide, LLC

Registry information

Official study title

Restoration of Disk Height Through Non-Invasive Spinal Decompression is Associated With Decreased Discogenic Low-Back Pain: A Retrospective Cohort Study

Important dates

First posted
Jan 26, 2009
Registry last updated
Jan 26, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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