Pilot Study to Evaluate The Effectiveness And Safety Of Axiom Worldwide Drx9000™ Spinal Decompression System

A Phase 2 study testing DRX9000™ in people with Low Back Pain, run by NEMA Research, Inc. at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Low Back Pain
What is being tested?: DRX9000™
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 3 sitesUnited States
Study dates: Dec 2006to Apr 2007
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 12Show fewer

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)

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Vibrance Medical Group
Beverly Hills, California, 90212
Naples Anesthesia and Pain Associates
Naples, Florida, 34108
Active Health and Wellness Center
Tampa, Florida, 33614

Other trials in United States

About this study

Official title: Pilot Study to Evaluate The Effectiveness And Safety Of Axiom Worldwide Drx9000™ Spinal Decompression System For Treatment of Low Back Pain

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

Read the detailed description

Currently, there are no prospective safety and/or outcomes studies utilizing the DRX9000™ in the peer-reviewed medical literature. There are published trials utilizing similar machines which provided evidence in support of the FDA granted indications for use spinal decompression and of the DRX9000™. Axiom Worldwide has determined it will be of benefit to the continuing medical care of patients and a furthering of the scientific knowledge of the treatment of LBP to complete such a prospective evaluation using a standardized treatment protocol. This study will therefore attempt to establish and validate the safety and efficacy of this computerized spinal decompression system in the treatment of LBP and sciatica.

Conditions: Low Back Pain
Being tested: DRX9000™
Medical subject headings: Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DRX9000™Device
Device is designed to apply spinal decompressive forces.

Study groups in NCT00414596
Study group	Role	What they receive
DRX Group	Experimental	Patients using the device DRX9000™. Receives: Device: DRX9000™

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Six weeks

Secondary outcomes (5)

Recurrence for Significant (VRS Greater Than or Equal to 4) LBP Following Completion of 6 Weeks of DRX9000 Treatment.
The number of Subjects reporting VRS greater than or equal to 4 for LBP following completion of 6 weeks of DRX9000 treatment will be recorded.
Measured: Six weeks
Change in Functional Capacity From Baseline to Six Weeks (The Revised Oswestry Pain Questionaire)
Subject functional capacity following 6 weeks of DRX9000 treatment will be measured as a numerical score by the Revised Oswestry Pain Questionaire (scale 0-50, 0=pain without effects). Functional capacity was assessed at Baseline, 3 Weeks and 6 Weeks.
Measured: Six weeks
Patient's Satisfaction With Treatment Procedures Following 6 Weeks of DRX9000 Treatment.
Patient's satisfaction with treatment procedures following 6 weeks of DRX9000 treatment was measured on a scale from 0-10 (0= very unsatisfied, 10=very satisfied).
Measured: Six weeks
Number of Adverse Events Following 6 Weeks of DRX9000 Treatment.
Total number of adverse events reported following 6 weeks of DRX9000 treatment.
Measured: Six weeks
Number of Patients Who Withdraw From Study.
Total number of patients who withdrew during the 6 weeks of treatment.
Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2006Apr 2007

First posted21 Dec 2006 (estimated)
Study startDec 2006
Primary completionApr 2007
Study completionApr 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Low Back PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00414596
Sponsor's protocol ID: P-AXW01
Status last verified: May 2016
First submitted: 19 Dec 2006
Last updated: 6 Jun 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Study to Evaluate The Effectiveness And Safety Of Axiom Worldwide Drx9000™ Spinal Decompression System For Treatment of Low Back Pain
ClinicalTrials.gov ID: NCT00414596
Acronym / sponsor ID: P-AXW01
Conditions: Low Back Pain
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: NEMA Research, Inc.Industry (pharma, biotech, devices)
Study start: Dec 2006
Primary completion: Apr 2007 (actual)
Study completion: Apr 2007 (actual)
First posted: 21 Dec 2006 (estimated)
Results: Posted 6 Jun 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
DRX Group	Experimental	Device: DRX9000™Patients using the device DRX9000™.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DRX9000™Device is designed to apply spinal decompressive forces.	Device	DRX Group

Primary outcome

Post-treatment Numerical Pain Intensity Rating Scale (VRS), Which is a Scale From 0-10 (0=no Pain, 10= Worst Pain)
Time frame: Six weeks
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.

5 secondary outcomes

Recurrence for Significant (VRS Greater Than or Equal to 4) LBP Following Completion of 6 Weeks of DRX9000 Treatment.
Time frame: Six weeks
Change in Functional Capacity From Baseline to Six Weeks (The Revised Oswestry Pain Questionaire)
Time frame: Six weeks
Patient's Satisfaction With Treatment Procedures Following 6 Weeks of DRX9000 Treatment.
Time frame: Six weeks
Number of Adverse Events Following 6 Weeks of DRX9000 Treatment.
Time frame: Six weeks
Number of Patients Who Withdraw From Study.
Time frame: 6 weeks

Results and safety

Results posted to the registry on 6 Jun 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DRX Group	20	18

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

Time frame: Six weeks. Median (Inter-Quartile Range). Unit: units on a scale

Measure	DRX Group n = 18
Value	0 (0 to 7)

DRX Group: p = .0001, Mixed Models Analysis

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DRX Group	0 of 20 (0%)	8 of 20 (40%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
click here for more information about the DRX9000Link provided by the sponsor.
Nema Research websiteLink provided by the sponsor.

Related trials for Low Back Pain

Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

John Leslie, MD principal investigator

Mayo Clinic

Charlotte Richmond, PhD study director

NEMA Research, Inc.

Joseph V Pergolizzi, MD study chair

Naples Anesthesia and Pain Associates

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DRX9000™ in people with Low Back Pain, run by NEMA Research, Inc. at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post-treatment Numerical Pain Intensity Rating Scale (VRS), Which is a Scale From 0-10 (0=no Pain, 10= Worst Pain) (time frame: Six weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00414596.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2016.