Pilot Study to Evaluate The Effectiveness And Safety Of Axiom Worldwide Drx9000™ Spinal Decompression System
Completed · Phase 2
Conditions studied: Low Back Pain
In brief
This pilot study will evaluate the effectiveness and safety of the Axiom Worldwide DRX9000 for active treatment of chronic low back pain.
Key facts
- Study ID
- NCT00414596
- Run by
- NEMA Research, Inc.
- People needed
- 20
- Starts
- 2006-12-01
- Expected to finish
- 2007-04-01
- Last updated by the study team
- 2016-06-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female, greater than 18 years of age
- Able to understand possible risks and benefits and provide written informed consent (ICF) to the IRB approved clinical multimodal protocol
- LBP with an intensity level of greater than 4 on an eleven point numerical pain rating scale (VRS) of 0-10 (with 0 - no pain and 10 - worst possible pain)
- Completed the necessary diagnostic and medical history evaluations as described in the protocol to confirm the patient's diagnosis and eligibility for the study and DRX9000 treatment protocol.
- Willing and able to complete a six week 20 session of DRX9000 outpatient treatments and a minimum of 6 months follow-up
You may not qualify if…
- Pregnancy
- Evidence of neurological motor deficits on clinical examination
- Evidence of spinal cord compression, metastatic cancer, tumor, hematoma, infection or compression fracture
- Evidence of severe central stenosis with neurological deficits or nerve root entrapment
- Litigation for health-related claim (in process or pending), Worker's Compensation, or Personal Injury
- Previous spine fusion surgery, insertion of hardware or artificial disc
- Hemiplegia or paraplegia
- History of severe cardiovascular or metabolic disease, or abdominal aortic aneurysm
- Unwillingness to postpone other types of therapy for LBP during the 6 week treatment sessions
- Known alcohol abuse or drug abuse
- Height less than 4 feet 10 inches (147 cm) or greater than 6 feet 8 inches (203 cm)
- Body weight greater than 300 pounds (136 kg)
Where it is running
- Vibrance Medical Group — Beverly Hills, California, United States
- Naples Anesthesia and Pain Associates — Naples, Florida, United States
- Active Health and Wellness Center — Tampa, Florida, United States
Full record on ClinicalTrials.gov
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