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MKT 0251 Pilot Study

ABSTRACT

objective:

Prospective, multicenter, phase ll, non-randomized clinical study to evaluate the effectiveness and safety of the Axiom Worldwide DRX9000® tm for active treatment of chronic LBP utillizing a standardized clinical research multimodal protocal.

METHODS:

20 patients with chionic LBP, based on a diagnosis of musculoskeletal or mechanical LBPherniated discs, bulging or protruding discs, degenerative disc, pain from failed back surgery more then 6 months  previously, posterior facet syndrome or sciatica underwent a series  of 20 DRX treatments (28 mins each) for weeks with 5 sessions the first week  tapering to 1 sessions, lumbar stretching exerciser and adjunct analgesic 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 age46.6,77.8% employed) had mean pain score 6.4 on a 0 to 10 scale (0=no pain 10=worst pain) Prior to first DRX treatment that decreased to 0. after last DRX treatment 88.9% of patients (16 outof 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 satisfed)  patients rated the DRX9000® an 8.1. no patient required any invasive therapies (e.g, eqidural injection, surgery).

CONCLUSION:

overall, patients pain improved after DRX 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 placebr 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 decopression system for the routine treatment of chronic LBP.

  • Paucity of literature on benefits of none-surgical spinal decompression over other non-surgicl treatments
  • Previous studies are poorly desigend
  • Results are descriptive in nature
  • Efficacy versues placebo or spontaneous recovery difficult to determine
  • Over 1200 DRX9000® in use today

MATERIALS AND METHODS

METHODS


  • Prospectiive, multi-center, phase ll, 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

-Tolal of 20 treatments

  • 5 sessions weeks 1&2
  • 3 sessions weeks 3&4
  • 2 sessions weeks 5&6
  • Additional Therapy

-ice therapy post DRX

-Back exercises after week 2

RESULTS

DEMOGRAPHICS
Total Number of Subjects=18
Male 66.7% Mean Age 46.6yrs
LBP symptom Duration(mean) 526
weeks
Mean Height 175 cm
Employed 77.8% Mean Weight 102 Kg
Retired 16.6% White 83.3%
Other 5.6% Hispanic 16.7%
FAILED THERAPY PRIOR TO DRX9000®
Procedure # Procedure #
Chiropractic 16 TENS 5
Muscle stimulation 10 Acupuncture 3
Ice Therapy 9 Lumbar Sopport 3
Massage Therapy 9 Epidural injections 3
Exercise 6 Facet injections 1
Heat 5 Ultrasound 1
Physical Therapy 5 Other Decom-pressive Therapy 1
FAILED THERAPY PRIOR TO DRX9000®
SUMMARY OF LOW BACK PAIN
DIAGNOSIS LOCATION
Bulging/Protruding Disc 15 L1-L2 1
Degenerative Disc 8 L2-L3 3
Herniated Disc 6 L3-L4 4
Posterior Facet Syndrome 2 L4-L5 14
Failed Back Surgery 1 L5-S1 12
ADVERSE EVENTS
Adverse Related to device Adverse Event Retated 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

RESULTS

CHANGE PAIN SCORE BY TREATMENT WEEK

CHANGE IN OSWESTRY SCORES

SATISFACTION SURVEY
Satisfaction by week Would you recommend DRX9000® to anyone else
Week 3 Week 6
7.6 8.1

CONCLUSION

  • A 6-week coures of 20 DRX9000® treatments significantly reduced the severity of chronic LBP in 89% (16 of 18) of treated patients form 6.4 to 3.1 after 2 week 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 the therapy
  • Adjunctive pain medication consumption was decreased by DRX9000® treatment
  • No sideficant adverse events or safety issues resulted from DRX9000® treatment
  • The DRX9000® shows great  promise in treating chronic LBP arising from multiipal causes
  • Comparative outcome trials utilizing a set of satndardized and validated multiple outcome variables as was utilized in this study are being planned to docment the value of DRX9000® non-surgical spinal decompression system in routine treatment of chronic LBP

The DRX9000® is the Worlds Most Advanced Non-Surgical Treatment for Back and Neck Pain

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