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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2007-04-30

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.

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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.

Conditions

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Low Back Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DRX Group

Patients using the device DRX9000™.

Group Type EXPERIMENTAL

DRX9000™

Intervention Type DEVICE

Device is designed to apply spinal decompressive forces.

Interventions

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DRX9000™

Device is designed to apply spinal decompressive forces.

Intervention Type DEVICE

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No