Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT00469118
Status:
WITHDRAWN
Last Update Posted:
2015-10-12
First Post:
2007-05-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Efficacy and Safety of Axiom Worldwide DRX9000 Axial Decompression System for Treatment of Low Back Pain
Sponsor:
NEMA Research, Inc.
Organization:
Study Overview
Official Title:
Clinical Efficacy and Safety of Axiom Worldwide DRX9000 Axial Decompression
Status:
WITHDRAWN
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Financial concerns with device manufacturer.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 clinical research multimodal protocol. During the first two weeks subjects are randomized to receive either conservative care or DRX treatment first and then cross over to receive either conservative care or DRX treatment the next 6 weeks. This study will test the hypothesis that standardized 6-week treatment regimen of spinal decompression using DRX9000™ will reduce chronic lower back pain more than conservative therapy (current baseline therapy).
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 clinical research multimodal protocol. During the first two weeks subjects are randomized to receive either conservative care or DRX treatment first and then cross over to receive either conservative care or DRX treatment the next 6 weeks. This study will test the hypothesis that standardized 6-week treatment regimen of spinal decompression using DRX9000™ will reduce chronic lower back pain more than conservative therapy (current baseline therapy
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: