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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NEMA Research, Inc.
ClinicalTrials.gov Identifier:
NCT00414596
First received: December 19, 2006
Last updated: May 4, 2016
Last verified: May 2016
  Purpose
This pilot study will evaluate the effectiveness and safety of the Axiom Worldwide DRX9000 for active treatment of chronic low back pain.

Condition Intervention Phase
Low Back Pain
Device: DRX9000™
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study to Evaluate The Effectiveness And Safety Of Axiom Worldwide Drx9000™ Spinal Decompression System For Treatment of Low Back Pain

Resource links provided by NLM:


Further study details as provided by NEMA Research, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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. [ Time Frame: Six weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: Six weeks ] [ Designated as safety issue: No ]
    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. [ Time Frame: Six weeks ] [ Designated as safety issue: No ]
    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. [ Time Frame: Six weeks ] [ Designated as safety issue: Yes ]
    Total number of adverse events reported following 6 weeks of DRX9000 treatment.

  • Number of Patients Who Withdraw From Study. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Total number of patients who withdrew during the 6 weeks of treatment.


Enrollment: 20
Study Start Date: December 2006
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DRX Group
Patients using the device DRX9000™.
Device: DRX9000™
Device is designed to apply spinal decompressive forces.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00414596

Locations
United States, California
Vibrance Medical Group
Beverly Hills, California, United States, 90212
United States, Florida
Naples Anesthesia and Pain Associates
Naples, Florida, United States, 34108
Active Health and Wellness Center
Tampa, Florida, United States, 33614
Sponsors and Collaborators
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
  More Information

Additional Information:
Responsible Party: NEMA Research, Inc.
ClinicalTrials.gov Identifier: NCT00414596     History of Changes
Other Study ID Numbers: P-AXW01 
Study First Received: December 19, 2006
Results First Received: April 28, 2009
Last Updated: May 4, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 24, 2016