Status:
COMPLETED
Restoration of Disc Height Reduces Chronic Low Back Pain
Lead Sponsor:
NEMA Research, Inc.
Collaborating Sponsors:
Axiom Worldwide, LLC
Conditions:
Chronic Low Back Pain
Eligibility:
All Genders
18+ years
Brief 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 hei...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
Trial Type :
OBSERVATIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00828880
Last Update
January 26 2009
Active Locations (1)
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1
Upper Valley Interventional Radiology
McAllen, Texas, United States, 78501