Clinical Evidence
Published or ongoing prospective clinical studies1-18
Peer-reviewed publications
DoD and NIH funding to support research
Goree 2024: RCT of 60-Day PNS for Post-surgical TKA Pain
This double-blinded, placebo-controlled RCT demonstrated significant pain relief and improved function with PNS for postoperative knee pain at the end of treatment (EOT) and 1-month after EOT.
Valimahomed 2024: RWE of PNS for Chronic Shoulder Pain
This retrospective analysis quantified improvements in multiple domains of health (e.g., sleep, physical function) at EOT among patients who received SPRINT for treatment of chronic shoulder pain.
Pritzlaff 2024: Review of Studies on PNS for Chronic Pain
This review summarizes findings from 10 prospective studies of PNS for chronic pain. Across all pain types included, patients reported substantial reductions in pain and/or pain interference with PNS.
Randomized controlled trials (RCTs)
SPRINT PNS is supported by clinical data from 7 successful RCTs, which have demonstrated clinically significant improvements in pain, functional outcomes, medication usage, and/or quality of life across a variety of pain conditions, such as:
- Shoulder Pain3, 5
- Post-Amputation Pain12, 15
- Post-Surgical Pain 14, 17
- Low Back Pain19
Real-world evidence
The largest retrospective review of real-word PNS data of over 6,100 patients, with over 71% demonstrating significant pain relief and/or improvement in quality of life following 60-day percutaneous PNS treatment with the SPRINT PNS System.20*
*The total rate of medical events collected from the product complaint database was approximately 6%, with skin irritation due to adhesive components as the most reported event.
References
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- Renzenbrink G, et al. Clin Rehabil. 2004; 18(4): 359-365.
- Chae J, et al. Am J Phys Med Rehabil. 2005; 84(11): 832-842.
- Chae J, et al. Pain Pract. 2013; 13(1): 59-67.
- Wilson R, et al. Am J Phys Med Rehabil. 2014; 93(1): 17-28.
- Wilson R, et al. Neuromodulation. 2014; 17(8): 771-776.
- Rauck R, et al. Neuromodulation. 2014; 17(2): 188-197.
- Ilfeld B, et al. Pain Pract. 2017; 17(7): 892-901.
- Ilfeld B, et al. J Orthop Surg Res. 2017; 12(1): 4.
- Wilson R, et al. Neuromodulation. 2018; 21(3): 290-295.
- Ilfeld B, et al. Neuromodulation. 2019; 22(5): 653-660.
- Gilmore C, et al. Neuromodulation. 2019; 22(5): 615-620.
- Gilmore C, et al. Reg Anesth Pain Med. 2020; 45(1): 44-51.
- Ilfeld B, et al. Anesthesiology. 2021; 135: 95–110.
- Albright-Trainer B, et al. Pain Mgmt. 2022; 12(3): 357-369.
- Gilmore C, et al. Interv Pain Med. 2023; 2(2): 100243.
- Goree J, et al. Neuromodulation. 2024; 27(5): 47-861.
- Ongoing studies listed on ClinicalTrials.gov as of January 21, 2025.
- McCormick Z, et al. Poster from NANS Annual Meeting 2025.
- Huntoon M, et al. Pain Physician. 2023; 26: 273-281.