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

Primary Purpose

Low Back Pain

Status
Withdrawn
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:

  • 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)

Sites / Locations

  • Johns Hopkins Bayview Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

DRX Treatment

Conservative Care

Arm Description

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.

Conservative non surgical therapy for 6 weeks prior to beginning DRX9000 treatment

Outcomes

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.

Secondary Outcome Measures

Incidence of adverse events
Recurrence rate, measured by the proportion of patients with VRS ≥ 4
Proportion of patients using adjuvant analgesic medication
Functional capacity, measured by the established Oswestry Disability Index
Patient's satisfaction with procedures and treatment

Full Information

First Posted
May 2, 2007
Last Updated
October 7, 2015
Sponsor
NEMA Research, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00469118
Brief Title
Clinical Efficacy and Safety of Axiom Worldwide DRX9000 Axial Decompression System for Treatment of Low Back Pain
Official Title
Clinical Efficacy and Safety of Axiom Worldwide DRX9000 Axial Decompression
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Financial concerns with device manufacturer.
Study Start Date
February 2009 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
Detailed Description
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

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
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DRX Treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Conservative Care
Arm Type
No Intervention
Arm Description
Conservative non surgical therapy for 6 weeks prior to beginning DRX9000 treatment
Intervention Type
Device
Intervention Name(s)
DRX9000™
Intervention Description
Nonsurgical spinal decompression
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Incidence of adverse events
Time Frame
1 year
Title
Recurrence rate, measured by the proportion of patients with VRS ≥ 4
Time Frame
1 year
Title
Proportion of patients using adjuvant analgesic medication
Time Frame
1 year
Title
Functional capacity, measured by the established Oswestry Disability Index
Time Frame
1 year
Title
Patient's satisfaction with procedures and treatment
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph V Pergolizzi, MD
Organizational Affiliation
NEMA Research, Inc.
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
Facility Information:
Facility Name
Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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