Restoration of Disc Height Reduces Chronic Low Back Pain

Completed

• Conditions: Chronic Low Back Pain
• Interventions: Device: DRX9000

• Registration Number: NCT00828880
• Lead Sponsor: NEMA Research, Inc.

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 height is associated with decreased LBP.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-01
• Study First Submitted: 2009-01-22
• Study First Submitted QC: 2009-01-23
• Last Update Submitted: 2009-01-23
• Study First Posted: 2009-01-26
• Last Update Posted: 2009-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
DRX9000	DRX9000	-

Trial Locations

Locations (1)

Upper Valley Interventional Radiology; 🇺🇸 McAllen, Texas, United States