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 LBP, herniated 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
Male66.7%Mean Age46.6yrs
LBP symptom Duration(mean)526
weeks
Mean Height175 cm
Employed77.8%Mean Weight102 Kg
Retired16.6%White83.3%
Other5.6%Hispanic16.7%
SUMMARY OF LOW BACK PAIN
DIAGNOSISLOCATION
Bulging/Protruding Disc15L1-L21
Degenerative Disc8L2-L33
Herniated Disc 6L3-L44
Posterior Facet Syndrome2L4-L514
Failed Back Surgery1L5-S112
FAILED THERAPY PRIOR TO DRX9000
Procedure#Procedure#
Chiropractic16TENS5
Muscle stimulation10Acupuncture3
Ice Therapy9Lumbar Sopport3
Massage Therapy9Epidural injections3
Exercise6Facet injections1
Heat5Ultrasound1
Physical Therapy5Other Decom-pressive Therapy1
ADVERSE EVENTS
AdverseRelated to deviceAdverse EventRetated to device
Neck PainPossiblyShoulder PainNo
Head Cold (2)NoLBP/flu-like SymptomsNo
Sinus headache(2)NoVertigoNo
Sinus infectionNoAdrenal insufficiencyNo

RESULTS

CHANGE PAIN SCORE BY TREATMENT WEEK

CHANGE IN OSWESTRY SCORES

SATISFACTION SURVEY
Satisfaction by weekWould 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