SCS Trial Evaluation in Diabetic Peripheral Neuropathy Patients: Real-World Evidence Collected using a Digital Health Platform
Introduction
•Diabetic peripheral neuropathy (DPN) is a common neuropathic syndrome seen in 30% of patients with diabetes1.
•DPN can present with painful symptoms including bilateral stabbing or burning pain, in addition to numbness in the feet and lower legs1.
•Spinal cord stimulation (SCS) is a non-opioid therapy that has been shown to be an effective treatment for painful DPN2-3.
•Prior to implantation of an SCS device, patients are required to trial the therapy using an external neurostimulator (SCSeval procedure).
•A retrospective sub-analysis of real-world data collected from patients with painful DPN who underwent SCSeval procedures was conducted utilizing a digital health platform.
Materials & Methods
•CareGuideProTM (CGP) is a mobile application that serves as a digital health platform for patient education, feedback, and patient reported outcomes throughout the course of their SCS journey.
•We conducted a retrospective sub-analysis of patients with DPN who underwent SCSeval procedures while utilizing CGP in the United States.
•We analyzed preoperative patient demographics and characterized patient pain profiles using PROMIS-29 (Patient-Reported Outcomes Measurement Information System®) surveys at baseline and at the end of the SCSeval procedure (EOT).
•The PROMIS-29 profile measure assesses seven domains (pain interference, ability to participate in social roles and activities, sleep disturbance, fatigue, depression, anxiety and physical function) and pain intensity.
•Higher PROMIS symptom scores reflect worse symptom burden, and higher PROMIS function scores reflect better functioning.
Results
•Between 2022-October-01 and 2023-July-28, 295 patients with a painful DPN indication underwent SCSeval procedures while utilizing CGP (Table 1).
•PROMIS-29 surveys were completed by 132 patients at baseline and 93 patients at EOT. P-values were computed considering only the cohort of patients with paired answers at baseline and EOT using a paired T-test (n=69).
•Average pain intensity scores (±standard deviation) improved from 7.5 (±1.4) at baseline to 3.9 (±2.0) at EOT (p < 0.001).
•Evaluation of SCS was associated with significant improvements (p < 0.001) in all PROMIS-29 domains (Figure 1), with 91.3% of patients reporting an improvement of at least 5 points and 94.3% of patients reporting an improvement of at least 3 points in any PROMIS domain.
Conclusions
•This retrospective sub-analysis of patients with DPN who underwent SCSeval procedures while utilizing CGP demonstrates that SCS therapy can provide significant improvement in pain-related symptoms.
•Findings from this analysis suggest SCS can be an effective therapy for painful DPN that should be considered when treating this patient population.
•Additionally, this study supports the use of digital health technology to allow for robust patient-reported outcomes collection.
References
1. Sloan G, et al. The treatment of painful diabetic neuropathy. Current Diabetes Reviews. 2022;18(5):e070721194556.
2. de Vos CC, et al. Spinal cord stimulation in patients with painful diabetic neuropathy: a multicentre randomized clinical trial. Pain. 2014;155(11):2426-31.
3. Slangen R, et al. Spinal cord stimulation and pain relief in painful diabetic peripheral neuropathy: a prospective two-center randomized controlled trial. Diabetes Care. 2014;37(11):3016-24.
4. Fishman M, et al. 12-Month Results from Multicenter, Open-Label, Randomized Controlled Clinical Trial Comparing Differential Target Multiplexed Spinal Cord Stimulation and Traditional Spinal Cord Stimulation in Subjects with Chronic Intractable Back Pain and Leg Pain. Pain Pract. 2021. Aug 7. doi: 10.1111/papr.13066.
5. Provenzano D, et al. A Prospective Multi-Center Study of a Reduced-Energy DTM™ Stimulation Derivative: Long-Term Outcomes in Therapy Naïve Patients. Poster presented at American Society of Regional Anesthesia and Pain Medicine (ASRA) Annual Pain Medicine Meeting; Nov. 17-19, 2022; Orlando, FL, USA.
6. Hatheway J, et al. Long-Term Efficacy of a Novel Spinal Cord Stimulation Clinical Workflow Using Kilohertz Stimulation: Twelve-Month Results From the Vectors Study. Neuromodulation. 2020. Oct 28. doi: 10.1111/ner.13324.
