Restoration of Disc Height Reduces Chronic Low Back Pain

NEMA Research

Status: Completed

Conditions: Chronic Low Back Pain

Treatments: Device: DRX9000

Study type: Observational

Funder types: Industry

Identifiers

NCT00828880

R-AXW01

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

0 participants in 1 patient group

DRX9000

Treatment:

Device: DRX9000