Spinal Cord Stimulation (SCS) as a treatment for chronic pain has been historically designated for patients who have had at least one prior spinal surgery. Considering the opioid crisis, and the often-mixed clinical success of conservative treatment approaches and invasive back surgery procedures, there is growing interest in utilizing SCS in chronic pain patients who have not yet undergone previous surgical intervention.1-4 Recent SCS devices offer substantially more novel technological or neurostimulative capabilities than older-generational SCS systems. Correspondingly, interventional treatment approaches capable of multimodal therapeutic strategies are now actively recommended by pain care advocates.5,6
This is a prospective, multicenter randomized, controlled study (SOLIS) that compares SCS (WavewriterTM SCS Systems, Boston Scientific, Valencia, CA, USA) versus Conventional Medical Management (CMM) in patients with chronic low back and/or leg pain with no prior spinal surgery (Clinicaltrials.gov: NCT04676022). Enrolled non-surgical back pain (NSBP) patients who met inclusion criteria were randomized to SCS versus CMM. Key inclusion criteria include diagnosis of chronic low back pain, with or without leg pain, for ≥6 months, and documented care of chronic pain for ≥90 days. The primary endpoint is responder rate (≥ 50% reduction in pain) with no increase in baseline opioid medications to treat pain at 3-months following treatment activation. Other secondary and/or exploratory measures include Quality-of-Life (SF-36; EQ-5D-5L), Disability (Oswestry Disability Index, ODI), and Safety Outcomes.
The study successfully met its primary endpoint (p < 0.0001) and secondary endpoints based on a prespecified cohort of 60 treatment activated subjects. The primary endpoint analysis demonstrated that multimodal SCS combined with CMM was superior to CMM alone (p<0.0001) in treating NSBP patients at 3-months follow-up (SCS: 88% versus CMM: 8%). A 27-point reduction in ODI score (improvement in disability) was noted in the SCS group in comparison to a 6-point reduction in the CMM group. Ninety-two percent of subjects with SCS reported treatment satisfaction (i.e., much, or very much improved) at 3-months versus only 6% in the CMM group.
Given the prevalence of non-surgical, refractory back pain and the increasing economic and societal burden it poses, providing SCS as an additional tool within the therapeutic armamentarium for chronic pain represents a key opportunity to address a clinically important need.
SCS with multiple modalities is effective in treating chronic pain in patients with no prior back surgery demonstrating superior outcomes compared with CMM. SOLIS RCT outcomes are consistent with those reported in a preceding RCT assessing patients diagnosed with currently-approved “on-label” chronic pain indications.7
1. Finnerup NB, Attal N, Haroutounian S, McNicol E, Baron R, Dworkin RH, Gilron I, Haanpää M, Hansson P, Jensen TS, Kamerman PR, Lund K, Moore A, Raja SN, Rice AS, Rowbotham M, Sena E, Siddall P, Smith BH, Wallace M. Pharmacotherapy for neuropathic pain in adults: a systematic review and meta-analysis. Lancet Neurol. 2015 Feb;14(2):162-73.
2. Al-Kaisy A, Van Buyten JP, Kapural L, Amirdelfan K, Gliner B, Caraway D, Subbaroyan J, Edgar D, Rotte A. 10 kHz spinal cord stimulation for the treatment of non-surgical refractory back pain: subanalysis of pooled data from two prospective studies. Anaesthesia. 2020 Jun;75(6):775-784.
3. Kapural L, Jameson J, Johnson C, Kloster D, Calodney A, Kosek P, Pilitsis J, Bendel M, Petersen E, Wu C, Cherry T, Lad SP, Yu C, Sayed D, Goree J, Lyons MK, Sack A, Bruce D, Rubenstein F, Province-Azalde R, Caraway D, Patel NP. Treatment of nonsurgical refractory back pain with high-frequency spinal cord stimulation at 10 kHz: 12-month results of a pragmatic, multicenter, randomized controlled trial. J Neurosurg Spine. 2022 Feb 11:1-12.
4. Kapural L, Calodney A. Retrospective Efficacy and Cost-Containment Assessment of 10 kHz Spinal Cord Stimulation (SCS) in Non-Surgical Refractory Back Pain Patients. J Pain Res. 2022 Nov 16;15:3589-3595.
5. U.S. Department of Health and Human Services, Alliance to Advance Comprehensive Integrative Pain Management (2019). Pain Management Best Practices Inter-Agency Task Force Report. https://painmanagementalliance.org/resources/hhs-report-2019/. Accessed October 28th, 2022.
6. Dowell D, Ragan KR, Jones CM, Baldwin GT, Chou R. CDC Clinical Practice Guideline for Prescribing Opioids for Pain - United States, 2022. MMWR Recomm Rep. 2022 Nov 4;71(3):1-95.
7. Wallace MS., et.al. Combination Therapy with Simultaneous Delivery of Spinal Cord Stimulation Modalities: COMBO Randomized Controlled Trial [Abstract]. NANS Annual Meeting, 2022.
1. To evaluate the use of SCS in the treatment of patients with non-surgical back pain (NSBP)
2. To compare pain relief outcomes of SCS versus Conventional Medical Management in a prospective randomized controlled trial for NSBP patients.
3, To compare quality-of-life outcomes of SCS versus Conventional Medical Management in a prospective randomized controlled trial for NSBP patients.