Clinical Efficacy and Safety of Axiom Worldwide DRX9000 Axial Decompression System for Treatment of Low Back Pain

This study has been terminated.
(Financial concerns with device manufacturer.)
Sponsor:
Information provided by (Responsible Party):
Joseph Pergolizzi, MD, NEMA Research, Inc.
ClinicalTrials.gov Identifier:
NCT00469118
First received: May 2, 2007
Last updated: October 16, 2012
Last verified: October 2012
  Purpose

This study will document efficacy and safety of the Axiom Worldwide DRX9000™ for treatment of low back pain (LBP) in a prospective, randomized, crossover, multicenter trial utilizing a standardized clinical research multimodal protocol. During the first two weeks subjects are randomized to receive either conservative care or DRX treatment first and then cross over to receive either conservative care or DRX treatment the next 6 weeks. This study will test the hypothesis that standardized 6-week treatment regimen of spinal decompression using DRX9000™ will reduce chronic lower back pain more than conservative therapy (current baseline therapy).


Condition Intervention Phase
Low Back Pain
Device: DRX9000™
Procedure: Conservative Care
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


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

Primary Outcome Measures:
  • The primary outcome measure is lower back pain measured on an 11-point numeric rating scale (VRS) with 0 reflecting no pain at all and 10 the worst imaginable pain. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Recurrence rate, measured by the proportion of patients with VRS ≥ 4 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Proportion of patients using adjuvant analgesic medication [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Functional capacity, measured by the established Oswestry Disability Index [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Patient's satisfaction with procedures and treatment [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: February 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DRX Treatment
20 treatments of spinal decompression over a six week period. Each session lasts about 45 minutes and consists of a 28-minute treatment on the DRX9000™ machine followed by 15 minutes of cold therapy to the lumbar paravertebral muscles.
Device: DRX9000™
Nonsurgical spinal decompression
Sham Comparator: Conservative Care
Conservative non surgical therapy for 6 weeks prior to beginning DRX9000 treatment
Procedure: Conservative Care

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • In addition to a diagnosis of LBP, ALL of the following criteria must be met:

    • Male or female, >18 years of age
    • Able to provide written informed consent (ICF) to the IRB approved clinical multimodal protocol
    • Chronic (onset more than 12 weeks) low back pain with an intensity level of > 4 on a verbal rating scale for pain (VRS) of 0-10 (with 0 = no pain and 10 = worst possible pain)
    • Completed necessary diagnostic medical history evaluation forms as described in the protocol to confirm the patient's diagnosis and eligibility for the study
    • Willing and able to complete the 6 week 20 session DRX9000 outpatient treatments and a minimum of 6 months follow-up

Exclusion Criteria:

  • If ANY of the following exclusion criteria are present, the subject is NOT eligible:

    • Pregnancy
    • Evidence of neurologic motor deficits on clinical examination
    • Evidence of spinal cord compression, metastatic cancer, tumor, hematoma, infection or compression fracture
    • Severe spinal stenosis
    • Litigation for health-related claim (in process or pending), Worker's Compensation, or Personal Injury cases
    • Previous spine fusion surgery or instrumentation
    • Hemiplegia or paraplegia
    • Significant cardiovascular or metabolic disease, or abdominal aortic aneurysm
    • Unwillingness to postpone other types of therapy for LBP that are not listed as adjuncts in the research protocol
    • 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: NCT00469118

Locations
United States, Maryland
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
NEMA Research, Inc.
Investigators
Principal Investigator: Joseph V Pergolizzi, MD NEMA Research, Inc.
Study Director: Charlotte Richmond, PhD NEMA Research, Inc.
  More Information

No publications provided

Responsible Party: Joseph Pergolizzi, MD, Principal Investigator, NEMA Research, Inc.
ClinicalTrials.gov Identifier: NCT00469118     History of Changes
Other Study ID Numbers: AXW01
Study First Received: May 2, 2007
Last Updated: October 16, 2012
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 July 29, 2014