NCT00414596

Brief Summary

This pilot study will evaluate the effectiveness and safety of the Axiom Worldwide DRX9000 for active treatment of chronic low back pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2 low-back-pain

Timeline
Completed

Started Dec 2006

Shorter than P25 for phase_2 low-back-pain

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

December 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 21, 2006

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
9.2 years until next milestone

Results Posted

Study results publicly available

June 6, 2016

Completed
Last Updated

June 6, 2016

Status Verified

May 1, 2016

Enrollment Period

4 months

First QC Date

December 19, 2006

Results QC Date

April 28, 2009

Last Update Submit

May 4, 2016

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

  • Post-treatment Numerical Pain Intensity Rating Scale (VRS), Which is a Scale From 0-10 (0=no Pain, 10= Worst Pain)

    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.

    Six weeks

Secondary Outcomes (5)

  • Recurrence for Significant (VRS Greater Than or Equal to 4) LBP Following Completion of 6 Weeks of DRX9000 Treatment.

    Six weeks

  • Change in Functional Capacity From Baseline to Six Weeks (The Revised Oswestry Pain Questionaire)

    Six weeks

  • Patient's Satisfaction With Treatment Procedures Following 6 Weeks of DRX9000 Treatment.

    Six weeks

  • Number of Adverse Events Following 6 Weeks of DRX9000 Treatment.

    Six weeks

  • Number of Patients Who Withdraw From Study.

    6 weeks

Study Arms (1)

DRX Group

EXPERIMENTAL

Patients using the device DRX9000™.

Device: DRX9000™

Interventions

DRX9000™DEVICE

Device is designed to apply spinal decompressive forces.

DRX Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Vibrance Medical Group

Beverly Hills, California, 90212, United States

Location

Naples Anesthesia and Pain Associates

Naples, Florida, 34108, United States

Location

Active Health and Wellness Center

Tampa, Florida, 33614, United States

Location

Related Links

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Jospeph V Pergolizzi, MD
Organization
NEMA Research, Inc
nemaresearch@aol.com
239-597-3564

Study Officials

  • John Leslie, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

  • Charlotte Richmond, PhD

    NEMA Research, Inc.

    STUDY DIRECTOR

  • Joseph V Pergolizzi, MD

    Naples Anesthesia and Pain Associates

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2006

First Posted

December 21, 2006

Study Start

December 1, 2006

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

June 6, 2016

Results First Posted

June 6, 2016

Record last verified: 2016-05

Locations

US(3)