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Pilot: Effectiveness and safety of non-surgical spinal decompression
Abstracts / Journal of Science and Medicine in Sport 12S (2009) S1–S83
optimising biomechanics in the lumbo/pelvic/hip complex will also be discussed. If motor control retraining is too undimensional and does not address retraining the complex proprioceptive and motor planning components of dynamics movement, than dysfunctional movement patterns can continue well after the initial pain has settled. An important question to be asked when rehabilitating athletes is: “Is the motor sequence being retrained actually reinforcing dysfunctional dynamic movement and/or shifting an abnormal load to another part of the kinetic chain.” doi:10.1016/j.jsams.2008.12.028
S11
the efficacy of the DRX9000 for the routine treatment of chronic LBP. doi:10.1016/j.jsams.2008.12.029 29 Restoration of disc height reduces chronic low back pain C. Apfel 1 , S. Cakmakkaya 1 , W. Martin 2 , F. Florio 3 , J. Pergolizzi 4 , C. Richmond 5,∗ 1 University
of California, San Francisco, United States Valley Interventional Radiology, United States 3 Axiom Worldwide, LLC, United States 4 Johns Hopkins University, United States 5 NEIV1A Research, Inc., United States 2 Upper
28 Pilot: Effectiveness and safety of non-surgical spinal decompression C. Richmond 1,∗ , J. Leslie 2 , A. Macarlo 3 , C. Apfel 4 , F. Florlo 5 , M. Auster 1 , J. Pergolizzi 1,6 1 NEIV1A
Research, Inc., United States Clinic, United States 3 Stanford University, United States 4 University of California, San Francisco, United States 5 Axiom Worldwide, LLC, United States 6 Johns Hopkins University, United States 2 Mayo
Purpose: To assess safety and efficacy of the DRX9000 non-surgical spinal decompression system for patients with chronic LBP. 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 (>6 months), posterior facet syndrome or sciatica underwent a series of 20 DRX treatments (28 mins each) for 6 weeks with five sessions the 1st week tapering to two session/week. The multimodal protocol included ice after DRX sessions, lumbar stretching exercises, and adjunct analgesics PRN. Assessments of pain, analgesic use, functionality, satisfaction, ADL and safety were collected. Results: 18 evaluable subjects had a change in mean VRS pain score from 6.4 (n = 18) (0 = no pain 10 = worst pain) at baseline that decreased to 0.8 (n = 17) at week 6 (p < 0.001). 16 out of 18 (88.9%) of the patients reported an improvement in pain. Oswestry Disability Index (ODI) score documented improved function in ADL (23.7 improving to 5.5, p < 0.001). On a 0–10 scale, patients rated DRX9000TM treatment 8.1. No patient required additional invasive therapies. No adverse events related to DRX9000 treatment occurred. 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 placebo or spontaneous recovery difficult to determine. Randomized double-blinded or comparative long-term outcome trials are needed to further prove
Objectives: To investigate whether a decrease in LBP secondary to a standardized treatment protocol using noninvasive spinal decompression correlates with an increase in disc height. Methods: Patients with chronic musculoskeletal, mechanical or discogenic LBP, underwent a 6-week course of non-invasive spinal decompression treatment using the DRX 9000TM . Data were retrospectively collected from lumbar spine CT scans taken prior to and after the intervention. Pain on palpation and range of motion (ROM) pain was recorded prior to and after treatment using a 11-point numeric rating scale (0–10). Linear regression was used to quantify any potential correlation between increased disc height and reduction in pain. Results: Sixteen patients were studied, with an average age of 71.5 ± 12.4 years and a history of LBP for an average of 5.4 ± 9.5 months. After 6 weeks of treatment palpation pain scores were reduced from 5.7 ± 2.8 to 0.8 ± 1.6, ROM pain scores were reduced from 5.6 ± 2.9 to 0.7 ± 1.6, and the average lumbar disc height was increased by 1.6 ± 0.8 mm. Furthermore, an increase of 1 mm in disc height was associated with a decrease of 3.4/10 for both palpation and ROM pain (P = 0.04). Conclusions: A significant reduction in chronic LBP after non-invasive spinal decompression correlated with an increase in disc height. A randomized controlled trial is needed to prove that restoration in disc height is the mechanism through which non-invasive spinal decompression leads to these impressive reductions in low back pain. doi:10.1016/j.jsams.2008.12.030 30 Peripheral nerve stimulation: A novel treatment for chronic low back pain and failed back surgery syndrome B. Mitchell ∗ , P. Verrills, D. Vivian, C. Sinclair, A. Barnard Metro Spinal Clinic, Melbourne, Australia Purpose: To assess the efficacy of peripheral nerve stimulation (PNS) for the treatment of chronic low back pain
optimising biomechanics in the lumbo/pelvic/hip complex will also be discussed. If motor control retraining is too undimensional and does not address retraining the complex proprioceptive and motor planning components of dynamics movement, than dysfunctional movement patterns can continue well after the initial pain has settled. An important question to be asked when rehabilitating athletes is: “Is the motor sequence being retrained actually reinforcing dysfunctional dynamic movement and/or shifting an abnormal load to another part of the kinetic chain.” doi:10.1016/j.jsams.2008.12.028
S11
the efficacy of the DRX9000 for the routine treatment of chronic LBP. doi:10.1016/j.jsams.2008.12.029 29 Restoration of disc height reduces chronic low back pain C. Apfel 1 , S. Cakmakkaya 1 , W. Martin 2 , F. Florio 3 , J. Pergolizzi 4 , C. Richmond 5,∗ 1 University
of California, San Francisco, United States Valley Interventional Radiology, United States 3 Axiom Worldwide, LLC, United States 4 Johns Hopkins University, United States 5 NEIV1A Research, Inc., United States 2 Upper
28 Pilot: Effectiveness and safety of non-surgical spinal decompression C. Richmond 1,∗ , J. Leslie 2 , A. Macarlo 3 , C. Apfel 4 , F. Florlo 5 , M. Auster 1 , J. Pergolizzi 1,6 1 NEIV1A
Research, Inc., United States Clinic, United States 3 Stanford University, United States 4 University of California, San Francisco, United States 5 Axiom Worldwide, LLC, United States 6 Johns Hopkins University, United States 2 Mayo
Purpose: To assess safety and efficacy of the DRX9000 non-surgical spinal decompression system for patients with chronic LBP. 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 (>6 months), posterior facet syndrome or sciatica underwent a series of 20 DRX treatments (28 mins each) for 6 weeks with five sessions the 1st week tapering to two session/week. The multimodal protocol included ice after DRX sessions, lumbar stretching exercises, and adjunct analgesics PRN. Assessments of pain, analgesic use, functionality, satisfaction, ADL and safety were collected. Results: 18 evaluable subjects had a change in mean VRS pain score from 6.4 (n = 18) (0 = no pain 10 = worst pain) at baseline that decreased to 0.8 (n = 17) at week 6 (p < 0.001). 16 out of 18 (88.9%) of the patients reported an improvement in pain. Oswestry Disability Index (ODI) score documented improved function in ADL (23.7 improving to 5.5, p < 0.001). On a 0–10 scale, patients rated DRX9000TM treatment 8.1. No patient required additional invasive therapies. No adverse events related to DRX9000 treatment occurred. 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 placebo or spontaneous recovery difficult to determine. Randomized double-blinded or comparative long-term outcome trials are needed to further prove
Objectives: To investigate whether a decrease in LBP secondary to a standardized treatment protocol using noninvasive spinal decompression correlates with an increase in disc height. Methods: Patients with chronic musculoskeletal, mechanical or discogenic LBP, underwent a 6-week course of non-invasive spinal decompression treatment using the DRX 9000TM . Data were retrospectively collected from lumbar spine CT scans taken prior to and after the intervention. Pain on palpation and range of motion (ROM) pain was recorded prior to and after treatment using a 11-point numeric rating scale (0–10). Linear regression was used to quantify any potential correlation between increased disc height and reduction in pain. Results: Sixteen patients were studied, with an average age of 71.5 ± 12.4 years and a history of LBP for an average of 5.4 ± 9.5 months. After 6 weeks of treatment palpation pain scores were reduced from 5.7 ± 2.8 to 0.8 ± 1.6, ROM pain scores were reduced from 5.6 ± 2.9 to 0.7 ± 1.6, and the average lumbar disc height was increased by 1.6 ± 0.8 mm. Furthermore, an increase of 1 mm in disc height was associated with a decrease of 3.4/10 for both palpation and ROM pain (P = 0.04). Conclusions: A significant reduction in chronic LBP after non-invasive spinal decompression correlated with an increase in disc height. A randomized controlled trial is needed to prove that restoration in disc height is the mechanism through which non-invasive spinal decompression leads to these impressive reductions in low back pain. doi:10.1016/j.jsams.2008.12.030 30 Peripheral nerve stimulation: A novel treatment for chronic low back pain and failed back surgery syndrome B. Mitchell ∗ , P. Verrills, D. Vivian, C. Sinclair, A. Barnard Metro Spinal Clinic, Melbourne, Australia Purpose: To assess the efficacy of peripheral nerve stimulation (PNS) for the treatment of chronic low back pain