Dr. Leslie of the Mayo Clinic Proves Spinal Decompression to be Up to 88.9% Effective for NECK and BACK PAIN !

OBJECTIVE:

Prospective, multicenter, phase II, non-randomized, clinical study to evaluate the effectiveness and safety of the Axiom Worldwide DRX9000^TM 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^TM 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^TM 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.

RESUTS:

18 evaluable subjects (33.3% female, 83.3% white, mean age 46.6, 77.8% employed) had mean pain score 6.4 on a 0 to 10 scale (0=no pain 10=worst pain) prior to first DRX^TM treatment that decreased to 0.8 after last DRX^TM treatment. 88.9% of patients (16 out of 18) reported an improvement in back pain, and better function as measured by activities of daily living. On a 0 to 10 scale (0=Not satisfied 10=Very satisfied) patients rated the DRX9000^TM an 8.1. No patient required any invasive therapies (e.g., epidural injections, surgery).

CONCLUSION:

Overall, patients’ pain improved after DRX^TM treatment, requiring fewer analgesics, with better function. There were no safety issues identified with the multimodal treatment routine. Non-treatment or control groups were not included making efficacy outcome versus placebo or spontaneous recovery difficult to determine. Randomized doubled-blinded or comparative long-term outcome trials are needed to further prove the efficacy of the DRX9000^TM non-surgical spinal decompression system for the routine treatment of chronic LBP.

• 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 DRX9000TM in use today

• A 6-week course of 20 DRX9000^TM treatments significantly reduced the severity of chronic LBP in 89% (16 of 18) of treated patients from 6.4 to 3.1 after 2 weeks and to only 0.8 (scale 0-10) after completion of treatment.

• Oswestry Disability scores improved from 23.7 to only 5.5 at end of therapy

• Adjunctive pain medication consumption was decreased by DRX9000^TM treatments

• No significant adverse events or safety issues resulted from DRX9000^TM treatments

• The DRX9000^TM shows great promise in treating chronic LBP arising from multiple causes

• Comparative outcome trials utilizing a set of standardized and validated multiple outcome variables, as was utilized in this study, are being planned to document the value of DRX9000^TM non-surgical spinal decompression system in routine treatment of chronic LBP

Subjects Conditions

• Herniated Discs
• Bulging Discs
• Degenerative Discs
• Failed Black Surgery
• Facet Syndrome

Prior to Treatment

• Average Pain Score 6.4 out of 10
• Pain Greater Than 6 Months

6 Week Treatment Protocol

• 20 Treatments

Post Treatment

• Average Pain Decreased to 0.8 out of 10
• Decrease Pain
• Improved Function
• Required Fewed Analgesics after treatment
• No Safety Issues or Adverse Effects