Restoration of Disc Height Reduces Chronic Low Back Pain

Chronic Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00828880
• Other study ID #: R-AXW01
• Status: Completed
• Phase: N/A
• First received: January 22, 2009
• Last updated: January 23, 2009

Study information

• Verified date: January 2009
• Source: NEMA Research, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

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

Locations

Country	Name	City	State
United States	Upper Valley Interventional Radiology	McAllen	Texas

Sponsors (2)

Lead Sponsor	Collaborator
NEMA Research, Inc.	Axiom Worldwide, LLC

Country where clinical trial is conducted

United States,