Status:
WITHDRAWN
Clinical Efficacy and Safety of Axiom Worldwide DRX9000 Axial Decompression System for Treatment of Low Back Pain
Lead Sponsor:
NEMA Research, Inc.
Conditions:
Low Back Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will document efficacy and safety of the Axiom Worldwide DRX9000™ for treatment of low back pain (LBP) in a prospective, randomized, crossover, multicenter trial utilizing a standardized cl...
Detailed Description
This study will document efficacy and safety of the Axiom Worldwide DRX9000™ for treatment of low back pain (LBP) in a prospective, randomized, crossover, multicenter trial utilizing a standardized cl...
Eligibility Criteria
Inclusion
- In addition to a diagnosis of LBP, ALL of the following criteria must be met:
- Male or female, \>18 years of age
- Able to provide written informed consent (ICF) to the IRB approved clinical multimodal protocol
- Chronic (onset more than 12 weeks) low back pain with an intensity level of \> 4 on a verbal rating scale for pain (VRS) of 0-10 (with 0 = no pain and 10 = worst possible pain)
- Completed necessary diagnostic medical history evaluation forms as described in the protocol to confirm the patient's diagnosis and eligibility for the study
- Willing and able to complete the 6 week 20 session DRX9000 outpatient treatments and a minimum of 6 months follow-up
Exclusion
- If ANY of the following exclusion criteria are present, the subject is NOT eligible:
- Pregnancy
- Evidence of neurologic motor deficits on clinical examination
- Evidence of spinal cord compression, metastatic cancer, tumor, hematoma, infection or compression fracture
- Severe spinal stenosis
- Litigation for health-related claim (in process or pending), Worker's Compensation, or Personal Injury cases
- Previous spine fusion surgery or instrumentation
- Hemiplegia or paraplegia
- Significant cardiovascular or metabolic disease, or abdominal aortic aneurysm
- Unwillingness to postpone other types of therapy for LBP that are not listed as adjuncts in the research protocol
- 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 :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00469118
Start Date
February 1 2009
End Date
February 1 2009
Last Update
October 12 2015
Active Locations (1)
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1
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224