Pilot Study to Evaluate The Effectiveness And Safety Of Axiom Worldwide Drx9000™ Spinal Decompression System

Study Overview
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Brief Summary
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This pilot study will evaluate the effectiveness and safety of the Axiom Worldwide DRX9000 for active treatment of chronic low back pain.

Detailed Description
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Currently, there are no prospective safety and/or outcomes studies utilizing the DRX9000™ in the peer-reviewed medical literature. There are published trials utilizing similar machines which provided evidence in support of the FDA granted indications for use spinal decompression and of the DRX9000™. Axiom Worldwide has determined it will be of benefit to the continuing medical care of patients and a furthering of the scientific knowledge of the treatment of LBP to complete such a prospective evaluation using a standardized treatment protocol. This study will therefore attempt to establish and validate the safety and efficacy of this computerized spinal decompression system in the treatment of LBP and sciatica.

Official Title
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Pilot Study to Evaluate The Effectiveness And Safety Of Axiom Worldwide Drx9000™ Spinal Decompression System For Treatment of Low Back Pain

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: 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)

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DRX Group<br>Patients using the device DRX9000™. | Device: DRX9000™<br>* Device is designed to apply spinal decompressive forces.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-treatment Numerical Pain Intensity Rating Scale (VRS), Which is a Scale From 0-10 (0=no Pain, 10= Worst Pain) | The numerical results of the post-treatment verbal numerical pain intensity rating scale (VRS) following completion of a standard six week series of 20 DRX9000 treatments. | Six weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence for Significant (VRS Greater Than or Equal to 4) LBP Following Completion of 6 Weeks of DRX9000 Treatment. | The number of Subjects reporting VRS greater than or equal to 4 for LBP following completion of 6 weeks of DRX9000 treatment will be recorded. | Six weeks | 
| Change in Functional Capacity From Baseline to Six Weeks (The Revised Oswestry Pain Questionaire) | Subject functional capacity following 6 weeks of DRX9000 treatment will be measured as a numerical score by the Revised Oswestry Pain Questionaire (scale 0-50, 0=pain without effects). Functional capacity was assessed at Baseline, 3 Weeks and 6 Weeks. | Six weeks | 
| Patient's Satisfaction With Treatment Procedures Following 6 Weeks of DRX9000 Treatment. | Patient's satisfaction with treatment procedures following 6 weeks of DRX9000 treatment was measured on a scale from 0-10 (0= very unsatisfied, 10=very satisfied). | Six weeks | 
| Number of Adverse Events Following 6 Weeks of DRX9000 Treatment. | Total number of adverse events reported following 6 weeks of DRX9000 treatment. | Six weeks | 
| Number of Patients Who Withdraw From Study. | Total number of patients who withdrew during the 6 weeks of treatment. | 6 weeks |