Comparing Conventional Medical Management to Spinal Cord Stimulation for the Treatment of Low Back Pain in a Cohort of DISTINCT RCT Patients

Abstract

Timothy Deer,1,* Robert Heros,2,* Edward Tavel,3 Sayed Wahezi,4 Robert Funk,5 Patrick Buchanan,6 Anne Christopher,7 Jacqueline Weisbein,8 Christopher Gilligan,9 Denis Patterson,10 Ajay Antony,11 Mohab Ibrahim,12 Nathan Miller,13 Keith Scarfo,14 Gayle Johnson,15 Thadchaigeni Panchalingam,15 Udoka Okaro,15 James Yue16 1Pain Management, The Spine and Nerve Center of the Virginias, Charleston, WV, USA; 2Pain Management, Spinal Diagnostics, Tualatin, OR, USA; 3Pain Management, Clinical Trials of South Carolina, Charleston, SC, USA; 4Pain Management, Montefiore Medical Center, Bronx, NY, USA; 5Pain Management, Indiana Spine Group, Indianapolis, IN, USA; 6Pain Management, Spanish Hills Interventional Pain Specialists, Camarillo, CA, USA; 7Pain Management, Saint Louis Pain Consultants, Chesterfield, MO, USA; 8Pain Management, Napa Valley Orthopedic Medical Group, Napa, CA, USA; 9Pain Management, Robert Wood Johnson University Hospital, New Brunswick, NJ, USA; 10Pain Management, Nevada Advanced Pain Specialists, Reno, NV, USA; 11Pain Management, the Orthopedic Institute, Gainesville, FL, USA; 12Pain Management, Coastal Pain & Spinal Diagnostics Medical Group, Carlsbad, CA, USA; 13Pain Management, Banner University Medical Center, Tucson, AZ, USA; 14Pain Management, Rhode Island Hospital, Providence, RI, USA; 15Neuromodulation, Abbott Labs, Austin, TX, USA; 16Orthopaedic spine Surgery, Connecticut Orthopedics, Hamden, CT, USA*These authors contributed equally to this workCorrespondence: Timothy Deer, Pain Management, The Spine and Nerve Center of the Virginias, 400 Court Street, Suite 100, Charleston, WV, 25301, USA, Tel [phone] – 6120, Fax [phone] – 6126, Email [email protected]: Low Back Pain (LBP) is a prevalent condition. Spinal cord stimulation (SCS) has emerged as a more effective, long-term treatment compared to conventional medical management (CMM). The DISTINCT study enrolled and randomized chronic LBP patients with no indication of traditional spine surgery. This analysis focuses comparing study outcomes on patients initially randomized to receive CMM treatment and subsequently crossed over to SCS after 6 months.Purpose: To compare the therapeutic effectiveness and cost-efficiency of passive recharge burst SCS to CMM.Patients and Methods: A total of 269 patients were enrolled with 162 randomly assigned to SCS and 107 to CMM. The DISTINCT study design allowed a crossover to the alternative treatment arm after 6 months. Patients underwent a trial and received a permanent implant if they reported ≥ 50% pain reduction. Outcome analysis included pain (NRS), disability (ODI), catastrophizing (PCS), quality of life (PROMIS-29) and health care utilization.Results: Seventy out of eighty-one patients opted to cross over to trial SCS at 6M with 94% (66/70) undergoing a trial. Among those, 88% (58/66) reported a ≥ 50% or more pain relief and 55 received a permanent implant. At 12M visit, 71.4% reported a ≥ 50% pain improvement sustained at the 18M visit, with 24.5% (12/49) indicating a ≥ 80% improvement. Disability reductions (79% meeting the minimally important difference of a 13-point decrease), decreased catastrophizing, and significant improvements in all PROMIS-29 domains were noted. Furthermore, 42% of the patients reported decreased or discontinued opioid usage. Clinical benefits at the 12M visit were sustained through the 18M visit accompanied by a significant reduction in healthcare utilization and a $1214 cost savings.Conclusion: SCS demonstrates superior, long-term performance and safety outcomes compared to CMM therapy in LBP patients who received both CMM and SCS therapy. Additionally, SCS patients experienced reduced healthcare resource utilization and lower costs compared to those receiving CMM.Keywords: DISTINCT, low back pain, BurstDR, spinal cord stimulation, healthcare utilization, persistent spinal pain syndrome, neuromodulation

Keywords

• distinct
• low back pain
• burstdr
• spinal cord stimulation
• healthcare utilization
• persistent spinal pain syndrome
• neuromodulation