Status:
COMPLETED
Pilot Study to Evaluate The Effectiveness And Safety Of Axiom Worldwide Drx9000™ Spinal Decompression System
Lead Sponsor:
NEMA Research, Inc.
Conditions:
Low Back Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This pilot study will evaluate the effectiveness and safety of the Axiom Worldwide DRX9000 for active treatment of chronic low back pain.
Detailed Description
Currently, there are no prospective safety and/or outcomes studies utilizing the DRX9000™ in the peer-reviewed medical literature. There are published trials utilizing similar machines which provided ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00414596
Start Date
December 1 2006
End Date
April 1 2007
Last Update
June 6 2016
Active Locations (3)
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1
Vibrance Medical Group
Beverly Hills, California, United States, 90212
2
Naples Anesthesia and Pain Associates
Naples, Florida, United States, 34108
3
Active Health and Wellness Center
Tampa, Florida, United States, 33614