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

NCT ID: NCT00469118

Last Updated: 2015-10-12

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2009-02-28

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

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

DRX9000™

Intervention Type: DEVICE

Nonsurgical spinal decompression

Conservative Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

DRX9000™

Nonsurgical spinal decompression

Intervention Type: DEVICE

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

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NEMA Research, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Joseph Pergolizzi, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joseph V Pergolizzi, MD

Role: PRINCIPAL_INVESTIGATOR

NEMA Research, Inc.

Charlotte Richmond, PhD

Role: STUDY_DIRECTOR

NEMA Research, Inc.

Locations

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

AXW01

Identifier Type: -

Identifier Source: org_study_id