Clinical Efficacy and Safety of Axiom Worldwide DRX9000 Axial Decompression System for Treatment of Low Back Pain

Study Overview
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Brief Summary
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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
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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

Official Title
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Clinical Efficacy and Safety of Axiom Worldwide DRX9000 Axial Decompression

Conditions
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Low Back Pain

Intervention / Treatment
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* Device: DRX9000™


Participation Criteria
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Eligibility Criteria
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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 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DRX Treatment<br>20 treatments of spinal decompression over a six week period. Each session lasts about 45 minutes and consists of a 28-minute treatment on the DRX9000™ machine followed by 15 minutes of cold therapy to the lumbar paravertebral muscles. | Device: DRX9000™<br>* Nonsurgical spinal decompression<br>|
| No Intervention: Conservative Care<br>Conservative non surgical therapy for 6 weeks prior to beginning DRX9000 treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |