Low Back Pain
Conditions
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
Interventions
DEVICEDRX9000™
Nonsurgical spinal decompression
Sponsors
NEMA Research, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* If ANY of the following
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events | 1 year |
| Recurrence rate, measured by the proportion of patients with VRS ≥ 4 | 1 year |
| Proportion of patients using adjuvant analgesic medication | 1 year |
| Functional capacity, measured by the established Oswestry Disability Index | 1 year |
| Patient's satisfaction with procedures and treatment | 1 year |
Countries
United States
Outcome results
None listed