ALL Major PPO & POS Insurance Plans Accepted:
Medicare
Anthem Blue Cross
Blue Shield
United Healthcare
Aetna * Cigna
Humana
PacifiCare
Great West
Fiserv Health
Beech Street
Call (949) 857-1888 for More Information
Conditions effectively treated with DRX9000 Spinal Decompression:
DRX9000 for Sciatica
DRX9000 for Herniated Discs
DRX9000 for Disc Bulges
DRX9000 for Degenerative Disc Disease
|
Excerpts from Magnetic Resonance Imaging (MRI) Findings after Treatment with DRX9000
Charlotte Richmond , PhD , Director of Clinical Research, NEMA Research, Inc., and CEO Biomedical Research and Education Foundation, LLC
Frank Florio , DC , Director of Clinical Research, Axiom Worldwide, LLC
Jonathan M Wilhelm , DC , CCEP, Big Sky Spinal Care Center
Martin Auster , MD , MBA, Assistant Professor, Department of Radiology, Johns Hopkins University School of Medicine
Published in U.S. Musculoskeletal Review
Click Image to Download Complete PDF
Introduction
Spinal decompression systems such as the DRX9000™ (Axiom Worldwide, Tampa, FL) have been launched into clinical practice in the last 10 years for the treatment of low-back pain (LBP). These systems were developed to provide a non-invasive intervention for the treatment of LBP of discogenic origin. They also address some of the problems associated with simple traction such as fatigue (both patient and therapist), the patient’s inability to tolerate the force or position, triggering of muscle spasm, and the exacerbation of pain. The US Food and Drug Administration (FDA)-cleared DRX9000 True Non-surgical Spinal Decompression System™ (see Figure 1) applies spinal distraction forces by using a sensitive computerized feedback mechanism to provide relief of LBP and symptoms associated with herniated discs, bulging or protruding inter-vertebral discs, degenerative disc disease, posterior facet syndrome, and sciatica. The DRX9000 uses a split-table design to reduce friction between the patient and the device. The patient lays supine; a chest and shoulder support system controls the upper body and a knee rest is used to eliminate pelvic rotation. The apparatus has built-in air bladders, disc-anglepull adjusters, and harnesses, and it can increase the decompression force more slowly in the latter part of the therapy. The DRX9000 uses a motor pulley to deliver mechanized segmental distraction, which can be delivered in a static or oscillatory fashion for a pre-selected duration; the location of lumbar spinal disease determines the best pull-angle settings.
The DRX9000 aims to relieve pain by enlarging intra-discal spaces, reducing herniation, and decreasing intra-discal pressure during treatment. A retrospective chart audit of 94 patients provided preliminary data that chronic LBP may improve with DRX9000 spinal decompression. 1 A prospective trial on 18 patients found that pain improved significantly after DRX9000 treatment, requiring fewer analgesics and resulting in better function.2 In view of such findings, corresponding radiographic data may be helpful to explain improvement in pain and function after DRX9000 treatment.
Presentation of Case
MRI of the lumbar spine performed on August 4, 2006 (see Figure 2) prior to treatment with the DRX9000 revealed mild to moderate degenerative disc disease of the lumbar spine with loss of disc signal at most levels, as well as disc bulges identified at L3/L4, L4/L5, and L5/S1. Prior to initial treatment, the patient reported an overall pain level of 6 on a 0–10 scale; this pain occurred 75% of the time. The patient underwent 20 treatments on the DRX9000 over a six-week period.
At his final DRX9000 treatment, the patient reported a pain level of 0. Follow-up MRI (see Figure 3) of the same patient performed on October 10, 2006 showed an increase in intra-discal signal on T2-weighted sagittal images at L2/3, L3/4, L4/5, and L5/S1, reflecting an improvement in disc morphology. The incidental small annular tears were unchanged.
Discussion
A recent review of clinical trials evaluating the efficacy of spinal decompression systems concluded that currently available data in the peer-reviewed press are too limited to determine whether spinal decompression provides benefits to individuals with LBP over other non-surgical treatments. 10 Previous studies include weak and inconsistent methodologies because of designs that included different sample sizes, clinical patient inclusion criteria, regulatory oversight levels, protocol lengths, and post-therapy follow-up. Investigators used inappropriate end-point measures and poor outcome markers, reported negative results inadequately, and neglected to include placebo controls. Since that review, two studies evaluating the DRX9000 have emerged. 1,2 The first study is retrospective and analyzes the treatment of 94 patients from September 2005 to March 2006 with the DRX9000. 1 The mean pre-DRX9000 pain score was 6.05 (0–10 scale) and decreased to 0.89 after the final DRX9000 session. No adverse events were noted. Results suggest that chronic LBP improved after treatment, with patients requiring fewer analgesics and achieving better function. The authors acknowledge the inconclusiveness of these findings as their study design was retrospective and did not include control groups. The second study, a prospective, multicenter, non-randomized, phase II pilot study to evaluate the effectiveness and safety of the DRX9000 for the active treatment of chronic LBP, followed subjects from January 5, 2007 to April 27, 2007. Twenty patients with chronic LBP—based on a diagnosis of musculoskeletal or mechanical LBP, herniated discs, bulging or protruding discs, degenerative disc disease, or pain from failed back surgery more than six months previously—underwent a series of 20 DRX9000 treatments (each session lasting 28 minutes) for six weeks, with five sessions per week in the first two weeks tapering to two sessions per week in the last two weeks. Adjunctive treatment included ice after DRX9000 sessions, lumbar stretching exercises, and analgesics as required. Assessments of pain, analgesic use, functionality, satisfaction, activities of daily living, and safety were collected through examinations, questionnaires, and patient diaries. Eighteen evaluable study participants (33.3% female; 83.3% white; mean age 46.6 years; 77.8% employed) had a mean pain score of 6.4 on a 0–10 scale prior to the first DRX9000 treatment; this decreased to 0.8 after the final DRX9000 treatment. Sixteen out of the 18 subjects (88.9%) reported an improvement in back pain and better function as measured by activities of daily living. On a 0–10 satisfaction scale, patients gave the DRX9000 an average score of 8.1. No patient required any invasive therapies (e.g. epidural injections, surgery). Overall, the pain of patients decreased by 50% after two weeks of DRX9000 treatment. Patients required fewer analgesics and experienced better function. No safety issues were identified with the multimodal treatment routine.
For LBP of discogenic origin, the goal of therapy is to expand the intervertebral space and reduce disc protrusion and intra-discal pressure,21–23 which are the goals of DRX9000 treatment. MRI is useful to quantify the volume and hydration variation of the inter-vertebral disc. 24 Therefore, the use of MRI to explain improvement in pain and function after DRX9000 treatment may be beneficial.
Our case report demonstrates the positive hydrating effect that the DRX9000 treatment has on the inter-vertebral disc. Further prospective clinical studies are needed to further validate clinical and radiographic improvement in patients with chronic LBP.
Important Facts About DRX9000 Spinal Decompression
DRX9000 Spinal Decompression is NOT traction. Traction is a consistent pull using a fixed amount of weight. DRX9000 Spinal Decompression is computer-controlled to vary the force of pull to maximize Disc Decompression.
DRX9000 Spinal Decompression is extremely safe. There have been no reports of patient injury or significant side effects since receiving FDA Approval in 2001.
DRX9000 Spinal Decompression is very effective. Recent studies have demonstrated success rates as high as 88.9% for patients matching an ideal diagnostic profile.
The DRX9000 Spinal Decompression Unit measures the treatment force thousands of times per second! This allows the Unit to increase or decrease the treatment pull within seconds to adjust to the needs of the patient. This technological advance is found ONLY in the DRX9000 Spinal Decompression Unit. Vax-D, Accu-Spina, SpineMED and DTS Traction tables DO NOT possess this capability!
Contact our office at (949) 857-1888 to arrange a consultation to determine if DRX9000 Spinal Decompression is right for you AND to determine your Insurance Coverage.
|
More DRX9000 Research Studies...
Nonsurgical Spinal Decompression to Treat Low Back Pain - Anesthesiology News
Treatment of 94 Outpatients with Chronic Discogenic Low Back Pain with the DRX9000
Management of Low Back Pain with DRX9000
Advances in Biotechnology Improve Clinical Outcomes for Spinal Decompression
Treatment of L5/S1 Extruded Disc Herniation with DRX9000
DRX9000 Spinal Decompression Testimonials:
The doctors and staff here are absolutely fantastic!
-- Eduardo P. – Long Beach, CA
I lived in fear of being permanently disabled…I was in pain all of the time – day and night. It's so exciting to have my life back!!!
-- Nancy L. – Irvine, CA
I had this problem for 30 years. After completing DRX9000 treatment I am completely pain-free with none of the previous symptoms. I can do any physical activity and have no discomfort whatsoever.
-- Richard A. – Irvine, CA
All of my symptoms and limitations were improved by 95%.
-- Diane F. – Irvine, CA
It is amazing! ...[T]he extreme pain that I was feeling is almost completely gone! I can’t believe how good I feel!
-- Alan M. – Rancho Santa Margarita, CA
When I first visited your office I had so much pain I couldn’t stand up straight and could walk only a few steps at a time…Now I am pain free, out riding my bike and playing golf again. I still can hardly believe it! You have given me my life back!
-- Dale H. – Austin, TX
Prior to DRX9000 Spinal Decompression treatment I could not walk! The pain in my lower back was very extreme and I could hardly take a step.
...I am totally rehabilitated. I have returned to working out at the gym and have even started yoga.
-- Truman P. – Irvine, CA
Thank you so much for helping me to recover from this back problem. I really am starting to feel like myself again after almost 3 years of dealing with all of the pain and stress. I sure am glad I didn't opt for surgery.
-- Nancy L. – Irvine, CA
Before Spinal Decompression I suffered from 3 herniated discs and 2 degenerated discs...I have my life and lifestyle back because of the treatments.
The office is extremely friendly…The doctors are extremely caring.
-- Argyle W. – Anaheim, CA
When I first came to your office I was experiencing constant lower back pain and was unable to do many of my daily activities. Now, after completing the Spinal Decompression Therapy, I feel like a new person! It is truly amazing!
-- Nancy H. – Mission Viejo, CA |
