Chronic Low Back Pain
Conditions
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.
Interventions
DEVICEDRX9000
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
Axiom Worldwide, LLC
NEMA Research, Inc.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Countries
United States
Outcome results
None listed