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.
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.
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).
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.