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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
DRX9000™
Sponsored by
NEMA Research, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Vibrance Medical Group
  • Naples Anesthesia and Pain Associates
  • Active Health and Wellness Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DRX Group

Arm Description

Patients using the device DRX9000™.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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).
Number of Adverse Events Following 6 Weeks of DRX9000 Treatment.
Total number of adverse events reported following 6 weeks of DRX9000 treatment.
Number of Patients Who Withdraw From Study.
Total number of patients who withdrew during the 6 weeks of treatment.

Full Information

First Posted
December 19, 2006
Last Updated
May 4, 2016
Sponsor
NEMA Research, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00414596
Brief Title
Pilot Study to Evaluate The Effectiveness And Safety Of Axiom Worldwide Drx9000™ Spinal Decompression System
Official Title
Pilot Study to Evaluate The Effectiveness And Safety Of Axiom Worldwide Drx9000™ Spinal Decompression System For Treatment of Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NEMA Research, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DRX Group
Arm Type
Experimental
Arm Description
Patients using the device DRX9000™.
Intervention Type
Device
Intervention Name(s)
DRX9000™
Intervention Description
Device is designed to apply spinal decompressive forces.
Primary Outcome Measure Information:
Title
Post-treatment Numerical Pain Intensity Rating Scale (VRS), Which is a Scale From 0-10 (0=no Pain, 10= Worst Pain)
Description
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.
Time Frame
Six weeks
Secondary Outcome Measure Information:
Title
Recurrence for Significant (VRS Greater Than or Equal to 4) LBP Following Completion of 6 Weeks of DRX9000 Treatment.
Description
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.
Time Frame
Six weeks
Title
Change in Functional Capacity From Baseline to Six Weeks (The Revised Oswestry Pain Questionaire)
Description
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.
Time Frame
Six weeks
Title
Patient's Satisfaction With Treatment Procedures Following 6 Weeks of DRX9000 Treatment.
Description
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).
Time Frame
Six weeks
Title
Number of Adverse Events Following 6 Weeks of DRX9000 Treatment.
Description
Total number of adverse events reported following 6 weeks of DRX9000 treatment.
Time Frame
Six weeks
Title
Number of Patients Who Withdraw From Study.
Description
Total number of patients who withdrew during the 6 weeks of treatment.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Leslie, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Charlotte Richmond, PhD
Organizational Affiliation
NEMA Research, Inc.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Joseph V Pergolizzi, MD
Organizational Affiliation
Naples Anesthesia and Pain Associates
Official's Role
Study Chair
Facility Information:
Facility Name
Vibrance Medical Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90212
Country
United States
Facility Name
Naples Anesthesia and Pain Associates
City
Naples
State/Province
Florida
ZIP/Postal Code
34108
Country
United States
Facility Name
Active Health and Wellness Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.axiomworldwide.com
Description
click here for more information about the DRX9000
URL
http://www.nema.net
Description
Nema Research website

Learn more about this trial

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

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