{
  "abstract": "Introduction Chronic low back pain is a major contributor to long-term disability. Many patients lack a clearly identifiable source for their pain on physical examination or imaging or present with multiple pain generators. This subset of patients, who do not have surgical pathology, relies on conservative medical management (CMM) in the absence of effective and lasting treatment alternatives. For those who fail to respond to CMM, spinal cord stimulation (SCS) should be considered as an effective adjunctive therapy for improving pain, disability and health-related quality of life.Methods SOLIS is a prospective, multicenter trial that randomized patients with non-surgical, refractory back pain (with or without leg pain) to receive either SCS combined with CMM or CMM alone. The primary endpoint at 3 months compared the proportion of patients with ≥50% overall pain relief without an increase in mean daily opioid use between the SCS+CMM and CMM groups. Three months after treatment activation, patients initially randomized to receive CMM alone had the option to cross over and add SCS to their pain management regimen. Patients in both randomized groups underwent 12-month follow-up visits to assess long-term effects on pain relief, disability, health-related quality of life, global impression of change, and treatment satisfaction.Results 147 patients were randomized to SCS+CMM (n=79) or CMM alone (n=68). At the 3-month follow-up, 89.5% of patients who received SCS+CMM (including subperception and paresthesia-based programming modalities) and 8.1% who received CMM alone were classified as study responders (≥50% pain relief without an increase in mean daily opioid use; modified intention-to-treat analysis, p<0.0001). The level of disability due to low back pain improved significantly: the Oswestry Disability Index score decreased by −27.5±15.9 points in the SCS+CMM group versus −7.2±9.9 points in the CMM alone group (p<0.0001). Health-related quality of life also improved at 3 months: the EuroQol 5 Dimension 5 Level questionnaire index score increased by 0.247±0.164 points in the SCS+CMM group versus 0.031±0.151 points in the CMM alone group (p<0.0001). The benefits of SCS were sustained until the 12-month visit. Seven patients experienced serious adverse events related to SCS, including 5 (3.6%) implant site infections resulting in explant.Conclusion SCS relieved pain and resulted in clinically significant improvements in functional disability and health-related quality of life in patients with non-surgical, refractory back pain with or without accompanying leg pain.Trial registration number NCT04676022.",
  "authors": [
    {
      "affiliations": [
        "Carolinas Pain Institute and Center for Clinical Research, Winston-Salem, North Carolina, USA"
      ],
      "name": "James North"
    },
    {
      "affiliations": [
        "Precision Spine Care, Tyler, Texas, USA"
      ],
      "name": "Aaron Calodney"
    },
    {
      "affiliations": [
        "The Denver Spine and Pain Institute, Denver, Colorado, USA"
      ],
      "name": "Drew Trainor"
    },
    {
      "affiliations": [
        "Department of Physical Medicine and Rehabilitation, University of Utah School of Medicine, Salt Lake City, Utah, USA"
      ],
      "name": "Zachary L McCormick"
    },
    {
      "affiliations": [
        "South Lake Pain Institute, Clermont, Florida, USA"
      ],
      "name": "Julio Paez"
    },
    {
      "affiliations": [
        "Piedmont Comprehensive Pain Management Group, Greenville, South Carolina, USA"
      ],
      "name": "Eric Loudermilk"
    },
    {
      "affiliations": [
        "Saint Louis Pain Consultants, Chesterfield, Montana, USA"
      ],
      "name": "Anne Christopher"
    },
    {
      "affiliations": [
        "Spine & Pain Specialists, Shreveport, Louisiana, USA"
      ],
      "name": "John Noles"
    },
    {
      "affiliations": [
        "Pacific Sports and Spine, Eugene, Oregon, USA"
      ],
      "name": "Gregory Phillips"
    },
    {
      "affiliations": [
        "Louisiana Pain Specialists, New Orleans, Louisiana, USA"
      ],
      "name": "Suneil Jolly"
    },
    {
      "affiliations": [
        "Summit Pain Alliance, Santa Rosa, California, USA"
      ],
      "name": "Michael I Yang"
    },
    {
      "affiliations": [
        "Ochsner Health System, New Orleans, Louisiana, USA",
        "Crimson Pain Management, Leawood, Kansas, USA"
      ],
      "name": "Maged Guirguis"
    },
    {
      "affiliations": [
        "Crimson Pain Management, Leawood, Kansas, USA"
      ],
      "name": "Daniel Kloster"
    },
    {
      "affiliations": [
        "Weill Cornell Medicine, New York, New York, USA"
      ],
      "name": "Daniel J Pak"
    },
    {
      "affiliations": [
        "Novant Health - Hawthorne, Winston-Salem, North Carolina, USA"
      ],
      "name": "Jeffery Peacock"
    },
    {
      "affiliations": [
        "Institute of Precision Pain Medicine, Corpus Christi, Texas, USA"
      ],
      "name": "Mitchell Engle"
    },
    {
      "affiliations": [
        "Carolinas Research Institute, PPLC, Huntersville, North Carolina, USA"
      ],
      "name": "Binit Shah"
    },
    {
      "affiliations": [
        "Goodman Campbell Brain and Spine, St. Vincent Health, Indianapolis, Indiana, USA"
      ],
      "name": "Derron Wilson"
    },
    {
      "affiliations": [
        "University of Chicago Hospital, Chicago, Illinois, USA"
      ],
      "name": "Magdalena Anitescu"
    },
    {
      "affiliations": [
        "Toledo Clinic, Toledo, Ohio, USA"
      ],
      "name": "Joseph Atallah"
    },
    {
      "affiliations": [
        "Forest Health Medical Center, Ypsilanti, Michigan, USA"
      ],
      "name": "John Chatas"
    },
    {
      "affiliations": [
        "Vitamed Research, Palm Desert, California, USA"
      ],
      "name": "Tim Leier"
    },
    {
      "affiliations": [
        "Fox Chase Pain Management, Trevose, Pennsylvania, USA"
      ],
      "name": "Steven Rosen"
    },
    {
      "affiliations": [
        "Boston Scientific Neuromodulation, Valencia, California, USA"
      ],
      "name": "Edward Goldberg"
    }
  ],
  "title": "Spinal cord stimulation plus conventional medical management versus conventional medical management alone for severe, non-surgical, refractory back pain: a randomized clinical trial followed by crossover",
  "uid": "a3a2c7b8-9386-5cb0-8ac4-fc1958d80051"
}