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Dr. Leslie of the Mayo Clinic Proves Spinal Decompression to be Up to 88.9% Effective for NECK and BACK PAIN !
PILOT: Effectiveness and Safety of Non-Surgical Spinal Decompression
Prospective, multicenter, phase II, non-randomized, clinical study to evaluate the effectiveness and safety of the Axiom Worldwide DRX9000TM for active treatment of chronic LBP utilizing a standardized clinical research multimodal protocol.
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 DRXTM treatments (28 mins each) for 6 weeks with 5 sessions the first week tapering to 1 session/wk. Treatment multimodal protocol included ice after DRXTM 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.
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 DRXTM treatment that decreased to 0.8 after last DRXTM 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 DRX9000TM an 8.1. No patient required any invasive therapies (e.g., epidural injections, surgery).
Overall, patients’ pain improved after DRXTM 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 DRX9000TM 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
MATERIALS & METHODS
A 6-week course of 20 DRX9000TM 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 DRX9000TM treatments
No significant adverse events or safety issues resulted from DRX9000TM treatments
The DRX9000TM 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 DRX9000TM non-surgical spinal decompression system in routine treatment of chronic LBP
SUMMARY OF PILOT STUDY
Conducted by: Mayo Clinic & Supervised by: John Leslie, M.D.
- 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
- Average Pain Decreased to 0.8 out of 10
- Decrease Pain
- Improved Function
- Required Fewed Analgesics after treatment
- No Safety Issues or Adverse Effects
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