23rd Annual Pain Medicine Meeting 2024

Beyond Pain Scores: How Real-World Outcomes Tell the Story of Quality of Life Improvements for Patients Treated with SCS

Melissa Murphy¹, Andrew Will², Thomas White³, Velimir Micovic⁴, Jugal Dalal⁵, David Provenzano⁶, Xiaoxi Sun⁷, Grace Santa Cruz Chavez⁷, Cory Goracke⁷

¹North Texas Orthopedics & Spine Center, Dallas-Fort Worth, TX, United States, ²Twin Cities Pain Clinic, Minneapolis, MN, United States, ³Procura Pain and Spine PLLC, Houston, TX, United States, ⁴Pain Management Consultants of Southwest Florida, Fort Myers, FL, United States, ⁵Novant Health Spine Specialists, Winston-Salem, NC, United States, ⁶Pain Diagnostics and Interventional Care, Sewickley, PA , ⁷Medtronic Neuromodulation, Minneapolis, MN, United States.

OBJECTIVE

•While pain intensity has been the cornerstone of demonstrating the efficacy of spinal cord stimulation (SCS) as a primary outcome measure for most SCS trials, it is also recognized that a broader view of multidimensional outcomes can provide value in understanding a patient’s overall response to therapy.

•Establishing a holistic view of patients in a real world setting and understanding how improvements in pain affect multiple facets of the patient’s life provides a broader picture of the benefits of SCS therapy for patients^1,2.

•PROMIS-29 is one way of looking at this holistic view of outcomes across seven health domains.

•Outcomes from PROMIS-29 were previously presented from the pilot phase of the SENSE SCS study^3,4.

•Here, we present real-world data collected from SENSE SCS study subjects, at baseline and three months post-device activation, describing functional and quality of life improvements in a variety of assessments, including across the seven health domains of PROMIS-29.

DESIGN

SENSE SCS – Study to Evaluate Neuromodulation Subject Experience with Contemporary Spinal Cord Stimulation Modalities for Chronic Pain

Design: Prospective, post-market, non-randomized, observational study, enrolling in the US only

•IRB approved study, registered on clinicaltrials.gov (NCT05775510)

•Hybrid decentralized model of execution

•Subjects with an on-label SCS indication eligible to enroll

Ongoing enrollment and follow-up; currently in a pilot phase with 9 active sites

Purpose: Evaluate workflow of a mobile clinical trial application for collection of PROs and to characterize outcomes on patient experience with commercially available Medtronic SCS devices.

•Subjects electronically consented using a custom-made mobile application, InsightPro™ clinical trial app

•Subjects were trialed and implanted with commercially available Medtronic SCS systems with a variety of programming types, including eCAP sensing-capable neurostimulators.

•PROs collected electronically using InsightPro™ at baseline, SCS trial, and after permanent SCS implantation through 12 months (3-month outcomes presented here)

EQ-5D-5L, PGIC, Satisfaction & Therapy Recommendation,

•PROMIS-29 (Patient-Reported Outcomes Measurement Information System®)⁵

RESULTS AND CONCLUSION

•SENSE SCS represents a novel approach to clinical trial design for SCS, enabling real-world data collection via a mobile application, including patient-reported outcome measures to assess the impact of SCS therapy on the overall quality of life and function of subjects.

•Increased percent of patients with normal function or mild impairment across all seven health domains of PROMIS-29 was observed.

•80% of subjects experienced quality of life improvement representative of a minimal clinically important difference.

•87% of subjects reported improvement in their condition at 3 months, with the majority of subjects reporting feeling “much improved” or “very much improved” (55%).

•Additionally, the majority of subjects were satisfied with the therapy and would recommend it (79%).

•Outcome measures from this study will continue to be reported.

CONCLUSION: These data demonstrate that improvements in functional outcomes across multiple health domains and assessments, underscoring the importance of assessing multidimensional patient-reported outcomes beyond just pain intensity.

REFERENCES

1.Blonde L, Khunti K, Harris SB, Meizinger C, Skolnik NS. Interpretation and Impact of Real-World Clinical Data for the Practicing Clinician. Adv Ther. 2018;35(11):1763-1774. doi:10.1007/s12325-018-0805-y

2. Tan YY, Papez V, Chang WH, Mueller SH, Denaxas S, Lai AG. Comparing clinical trial population representativeness to real-world populations: an external validity analysis encompassing 43 895 trials and 5 685 738 individuals across 989 unique drugs and 286 conditions in England. Lancet Healthy Longev. 2022;3(10):e674-e689. doi:10.1016/S2666-7568(22)00186-6

3. Murphy, M.; Will, A.; White, T.; Micovic, V,; Dalal, J.; Sun, X.; Santa Cruz Chavez, G.; Archila, L.; Chakravarthy, K. Using a Novel Hybrid Decentralized Clinical Study to Evaluate Real-World Outcomes for Spinal Cord Stimulation (SCS) Therapies. 2024. INS Poster.

4. Murphy, M.; Will, A.; White, T.; Micovic, V,; Dalal, J.; Stromberg, K.; Santa Cruz Chavez, G.; Goracke, C. Real-World Holistic Outcomes for Spinal Cord Stimulation (SCS) Therapies Utilizing a Hybrid Decentralized Clinical Study Design. 2024. ASPN Poster.

5. Hays RD, Spritzer KL, Schalet BD, Cella D: PROMIS(*)-29 v2.0 profile physical and mental health summary scores. Quality of Life Research 27 (7): 1885-1891, 2018.

6. Walters SJ, Brazier JE. Comparison of the minimally important difference for two health state utility measures: EQ-5D and SF-6D. Qual Life Res. 2005;14(6):1523-1532. doi:10.1007/s11136-004-7713-0 (MCID value is 0.074)

23rd Annual Pain Medicine Meeting 2024

BEYOND PAIN SCORES: HOW REAL-WORLD OUTCOMES TELL THE STORY OF QUALITY OF LIFE IMPROVEMENTS FOR PATIENTS TREATED WITH SCS.

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