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  • Design of a multicenter randomized controlled study comparing clinical- and cost-effectiveness of spinal cord stimulation at 10 kHz to best medical management for treatment of refractory back pain in

    Final Number:

    C. Wu; J. Pilitsis; N. Patel; N. Lad; A. Calodney; J. Scowcroft; T. Cherry; L. Kapural; D. Sayed; S. Nalamachu; D. Kloster; P. Kosek; R. Province-Azalde; J. Subbaroyan; B. Gliner; D. Caraway; A. Sharan

    Study Design:
    Clinical trial

    Subject Category:

    Meeting: Congress of Neurological Surgeons 2018 Annual Meeting - Late Breaking Science

    Introduction: Few treatment options exist for chronic back pain patients who have failed conventional medical management (CMM) and are not candidates for back surgery (1). We refer to this population as non-surgical refractory back pain (NSRBP) patients. Some payers limit spinal cord stimulation (SCS) reimbursement only to patients who have failed surgical intervention, a population that has been addressed in at least 3 RCTs (2,3,4). A small feasibility study has shown that SCS at 10 kHz (SCS-10kHz) is effective in the NSRBP population (5), but no level 1 evidence exists.

    Methods: The study will provide evidence to clinicians and healthcare payers comparing SCS-10kHz plus CMM therapy to CMM alone terms of pain relief and quality of life measures, and improved cost-effectiveness.In this study, CMM is appropriate medical management as determined by the investigator to be the best standard of care for each individual patient. Treatment with CMM will be randomized 1:1 against SCS-10kHz plus CMM.

    Results: The primary endpoint will be proportion of subjects in each treatment group achieving at least 50% back pain relief compared to baseline. The secondary endpoints will comparatively analyze SCS-10kHz vs CMM in terms of patient reported outcomes (disability, impression of change in overall health condition, health related quality of life), and change in opioid equivalent medication usage. Health care utilization and work status will be used in a cost-effectiveness analysis. The rate of treatment related adverse events will be compared. After 6 months, there will be an opportunity for participants to cross over to the other treatment group. Outcome data will be collected and analyzed at baseline, 3, 6, 9, and 12 months.

    Conclusions: This study is significant in that it will provide level 1 evidence to guide treatment options for surgery naïve patients with refractory back pain, who are ineligible for surgery.

    Patient Care: The study of spinal cord stimulation as a treatment option is important because few options are available for this surgery naive patient group with refractory back pain. This therapy provides an alternative to opioid use.

    Learning Objectives: By the conclusion of the session, participants should be able to 1) Describe the state of evidence for SCS in refractory back pain without previous surgery. 2) Identify SCS as a potential treatment, important outcomes, current challenges

    References: 1. Koes BW, Backes D, Bindels PJE. Pharmacotherapy for chronic non-specific low back pain: current and future options. Expert Opin Pharmacother. 2018;19(6):537-45. 2. North RB, Kidd DH, Farrokhi F, Piantadosi SA. Spinal cord stimulation versus repeated lumbosacral spine surgery for chronic pain: a randomized, controlled trial. Neurosurgery. 2005;56(1):98-106; discussion -7. 3. Kumar K, North R, Taylor R, Sculpher M, Van den Abeele C, Gehring M, et al. Spinal Cord Stimulation vs. Conventional Medical Management: A Prospective, Randomized, Controlled, Multicenter Study of Patients with Failed Back Surgery Syndrome (PROCESS Study). Neuromodulation. 2005;8(4):213-8. 4. Kapural L, Yu C, Doust MW, Gliner BE, Vallejo R, Sitzman BT, et al. Novel 10-kHz High-frequency Therapy (HF10 Therapy) Is Superior to Traditional Low-frequency Spinal Cord Stimulation for the Treatment of Chronic Back and Leg PainThe SENZA-RCT Randomized Controlled Trial. Anesthesiology. 2015;123(4):851-60. 5. Al-Kaisy A, Palmisani S, Smith TE, Carganillo R, Houghton R, Pang D, et al. Long-Term Improvements in Chronic Axial Low Back Pain Patients Without Previous Spinal Surgery: A Cohort Analysis of 10-kHz High-Frequency Spinal Cord Stimulation over 36 Months. Pain Med. 2017.

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