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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Nonsurgical spinal decompression
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States
The primary outcome measure is lower back pain measured on an 11-point numeric rating scale (VRS) with 0 reflecting no pain at all and 10 the worst imaginable pain.
Time frame: 1 year
Incidence of adverse events
Time frame: 1 year
Recurrence rate, measured by the proportion of patients with VRS ≥ 4
Time frame: 1 year
Proportion of patients using adjuvant analgesic medication
Time frame: 1 year
Functional capacity, measured by the established Oswestry Disability Index
Time frame: 1 year
Patient's satisfaction with procedures and treatment
Time frame: 1 year
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