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

May 4, 2016 updated by: NEMA Research, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Beverly Hills, California, United States, 90212
        • Vibrance Medical Group
    • Florida
      • Naples, Florida, United States, 34108
        • Naples Anesthesia and Pain Associates
      • Tampa, Florida, United States, 33614
        • Active Health and Wellness Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

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)
Time Frame: Six weeks
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.
Time Frame: Six weeks
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)
Time Frame: Six weeks
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.
Time Frame: Six weeks
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.
Time Frame: Six weeks
Total number of adverse events reported following 6 weeks of DRX9000 treatment.
Six weeks
Number of Patients Who Withdraw From Study.
Time Frame: 6 weeks
Total number of patients who withdrew during the 6 weeks of treatment.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NEMA Research, Inc.

Investigators

  • Principal Investigator: John Leslie, MD, Mayo Clinic
  • Study Director: Charlotte Richmond, PhD, NEMA Research, Inc.
  • Study Chair: Joseph V Pergolizzi, MD, Naples Anesthesia and Pain Associates

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

December 19, 2006

First Submitted That Met QC Criteria

December 19, 2006

First Posted (Estimate)

December 21, 2006

Study Record Updates

Last Update Posted (Estimate)

June 6, 2016

Last Update Submitted That Met QC Criteria

May 4, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P-AXW01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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