EFFECTIVENESS & SAFET Y OF NON-SURGICAL SPINAL DECOMPRESSION

I recently obtained a recent study on the DRX 9000 spinal decompression table, it shows a 89% percent success rate. Of course we need randomized double blind studies, this is a start in the right direction.
I am confident that within a year we will have these studies and spinal decompression on the DRX 9000 will be the standard of care for management of disc herniations.
www.drshoshany.com



Effectiveness and Safety of Non-Surgical Spinal Decompression as presented at the American Academy of Pain Management AAPM 18th. Annual Clinical Meeting September 27-30, 2007

John Leslie MD, Charlotte Richmond, PhD, Alex Macario, MD, Christian Apfel, MD, Frank Florio,DC, Darren Clair, MD, Joseph Pergolizzi, MD

Mayo Clinc, Universty of California at San Francisco, John Hopkins University

EFFECTIVENESS & SAFET Y OF NON-SURGICAL SPINAL DECOMPRESSION
OBJECTIVE :Prospective, multi-center, phase II, non-randomized clinical study to evaluate the effectiveness and safety of the Axiom Worldwide DRX9000 for active treatment of chronic LBP utilizing a standardized clinical research multimodal protocol.
METHODS: 20 patients with chronic LBP based on a diagnosis of musculoskeletal or mechanical LBP, herniated discs bulging or protruding discs, degenerative disc, pain from failed back surgery more than 6 months previously, posterior facet syndrome or sciatica underwent a series of 20 DRX treatments (28 mins each) for 6 weeks with 5 sessions the first week tapering to 1 session/wk. Treatment multimodal protocol included ice after DRX sessions, lumbar stretching exercises, and adjunct analgesics as required. Assessments of pain, analgesic use, functionality, satisfaction, activities of daily living and safety were collected through examinations, questionnaires and patient diaries.
RESULTS: 18 evaluable subjects (33.3%female,83.3% white, mean age 44.6, 77.8% employed) had mean pain score 5.8 on a 0 to 10 scale(0 = no pain 10 = worst pain) at initial presentation that decreased to 2.9 after last DRX treatment. Patients reported a mean 88.9% (16 out of 18) improvement in back pain, and a better function as measured by activities of daily living. On a ) to 10 scale (0 = not satisfied 10 = very satisfied) patients rated the DRX9000 an 8.1 . No patient required any invasive therapies (e.g. , epidural injections, surgery).
CONCLUSION: Overall, patients’ pain improved immediately after DRX treatment, requiring fewer analgesics, with better function. There were no safety issues identified with multimodal treatment routine. Non-treatment or control groups were not included making efficacy outcome versus placebo or spontaneous recovery difficult to determine. Randomized double-blinded or comparative long-term outcome trials are needed to further prove the efficacy of the DRX9000 non-surgical spinal decompression system for the routine treatment of chronic LBP.
DISCLOSURE: This study was funded by Axiom Worldwide.

BACKGROUND
Paucity of literature on benefits of non-surgical spinal decompression over other non-surgical treatments
Previous studies are poorly designed
Results are descriptive in nature
Efficacy versus placebo or spontaneous recovery difficult to determine
Over 1,200 DRX9000 in use today
MATERIALS & METHODS
METHODS
Prospective, multi-center, Phase II , non-randomized clinical trial
3 free- standing clinics (2 MDs and 1DC)
Diagnosis: Low back pain > 12 weeks
Outcome measures assessed:
Daily Pain Diary
Verbal Rating Scale (VRS)
Oswestry Pain Questionnaire
Adverse Events
Satisfaction Survey
TREATMENT PROTOCOL
DRX9000 sessions
28 minute sessions for 6 weeks
Total of 20 treatments
5 sessions week 1&2
3 sessions week 3&4
2 sessions week 5&6
Additional Therapy
Ice therapy post DRX
Back exercises after week 2

FAILED THERAPY PRIOR TO DRX9000
PROCEDURE # PROCEDURE # PROCEDURE
CHIROPRACTIC 16 TENS 5 Facet injections 1
MUSCLE STIMULATION 10 ACUPUNCTURE 3 Ultra sound 1
ICE THERAPY 9 LUMBAR SUPPORT 3 Other Decompressive therapy 1
MASSAGE THERAPY 9 Epidural injections 3

ADVERSE EVENTS
ADVERSE EVENT RELATED TO DEVICE ADVERSE EVENT RELATED TO DEVICE
Neck Pain Possibly Shoulder pain No
Head cold (2) No LBP/flu like symptoms No

Sinus headache 2) No
Vertigo No
Sinus Infection No
Adrenal Insufficiency No


Week 3 Week 6 Would you recommend DRX9000 to anyone else?
7.6 8.1 Yes 88.9% No 11.1%
www.drshoshany.com
Manhattan's Spinal decompression specialist
If you suffer with chronic back pain or have been diagnosed with a herniated disc call (212) 645-8151 for Non surgical spinal decompression