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

Low Back Pain Clinical Trial

Official title:

Clinical Efficacy and Safety of Axiom Worldwide DRX9000 Axial Decompression

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00469118
• Other study ID #: AXW01
• Status: Withdrawn
• Phase: Phase 2
• First received: May 2, 2007
• Last updated: October 7, 2015
• Start date: February 2009
• Est. completion date: February 2009

Study information

• Verified date: October 2015
• Source: NEMA Research, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Device:
• DRX9000™
Nonsurgical spinal decompression

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
NEMA Research, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		1 year	No
Secondary	Incidence of adverse events		1 year	Yes
Secondary	Recurrence rate, measured by the proportion of patients with VRS = 4		1 year	No
Secondary	Proportion of patients using adjuvant analgesic medication		1 year	No
Secondary	Functional capacity, measured by the established Oswestry Disability Index		1 year	No
Secondary	Patient's satisfaction with procedures and treatment		1 year	No