Pilot Study to Evaluate The Effectiveness And Safety Of Axiom Worldwide Drx9000™ Spinal Decompression System
This study has been completed.
Sponsor:
NEMA Research, Inc.
Information provided by:
NEMA Research, Inc.
ClinicalTrials.gov Identifier:
NCT00414596
First received: December 19, 2006
Last updated: February 12, 2009
Last verified: February 2009
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Purpose
This pilot study will evaluate the effectiveness and safety of the Axiom Worldwide DRX9000 for active treatment of chronic low back pain.
| Condition | Intervention |
|---|---|
|
Low Back Pain |
Device: DRX9000™ |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pilot Study to Evaluate The Effectiveness And Safety Of Axiom Worldwide Drx9000™ Spinal Decompression System For Treatment of Low Back Pain |
Resource links provided by NLM:
Further study details as provided by NEMA Research, Inc.:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00414596
Locations
| United States, California | |
| Vibrance Medical Group | |
| Beverly Hills, California, United States, 90212 | |
| United States, Florida | |
| Naples Anesthesia and Pain Associates | |
| Naples, Florida, United States, 34108 | |
| Active Health and Wellness Center | |
| Tampa, Florida, United States, 33614 | |
Sponsors and Collaborators
NEMA Research, Inc.
Investigators
| Principal Investigator: | John Leslie, MD | Mayo Clinic |
| Study Director: | Charlotte Richmond, PhD | NEMA Research, Inc. |
| Study Chair: | Joseph V Pergolizzi, MD | Naples Anesthesia and Pain Associates |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00414596 History of Changes |
| Other Study ID Numbers: | P-AXW01 |
| Study First Received: | December 19, 2006 |
| Last Updated: | February 12, 2009 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Back Pain Low Back Pain Pain |
Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 22, 2013