# Electrical stimulation to reduce pain and improve function after knee replacement

> **NIH NIH R44** · SPR THERAPEUTICS, LLC · 2021 · $954,397

## Abstract

PROJECT SUMMARY
 Total knee arthroplasty (TKA) is a widely-performed surgical procedure to treat disabling knee conditions,
but approximately half of all TKA patients experience moderate to severe pain during the critical first 4 weeks
after TKA that can interfere with rehabilitation. Patients who are unable to engage fully in rehabilitation during
this period risk substantial delays in return to normal function, reduced independence and quality of life, and
have increased risk of developing chronic pain. Despite use of multimodal pain management, many patients still
experience significant pain and require opioids that are associated with debilitating side effects, interfering with
rehabilitation and delaying recovery during the critical first 4 weeks after TKA. The previous Phase I and II studies
were successfully completed, demonstrating that percutaneous peripheral nerve stimulation (PNS) can provide
immediate improvements in postoperative pain and knee mobility and produces greater relief of postoperative
pain and improved function compared to standard of care alone during the first 4 weeks following TKA, resulting
in lower incidence of chronic postoperative pain and opioid use at 3 months following TKA.
 The goal of the present Phase IIB project is to develop and test an advanced percutaneous PNS system that
can: translate into routine clinical practice the benefits demonstrated in the previous Phase I and II clinical
studies, overcome the challenges documented in these studies, and meet the design requirements to be
deployed consistently and successfully by physicians with a wide range of skill sets in anesthetized patients
before surgery to treat postoperative pain consistently throughout the critical postoperative 4-week rehabilitation
window without the limitations of the existing standard of care. The project aims are to develop and test a multi-
contact open-coil lead designed to widen the target area in which the lead can be placed using only anatomical
landmarks and ultrasound guidance, avoiding the need to test stimulation and assess patient feedback (Aim 1);
develop and test a unified introducer and connector system to enable a single physician to quickly and accurately
deploy the lead followed by the lead connector without assistance (Aim 2); develop and test the external pulse
generator, cabling, and user interfaces to complete development of the system (Aim 3); and determine if the
proposed system enables quick and accurate lead placement in a clinical study (Aim 4). Successful completion
of the aims will result in a novel percutaneous PNS system that is ready for submission for FDA 510(k) clearance,
with a goal of providing in diverse healthcare settings the same pain relief, opioid reduction, and functional
improvements demonstrated in previous studies in expert research settings. Commercialization of this innovative
PNS system will substantially impact clinical practice by providing physicians and their patients with a non-op...

## Key facts

- **NIH application ID:** 10324450
- **Project number:** 2R44AG052196-04A1
- **Recipient organization:** SPR THERAPEUTICS, LLC
- **Principal Investigator:** Joseph Wilder Boggs
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $954,397
- **Award type:** 2
- **Project period:** 2015-08-15 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10324450

## Citation

> US National Institutes of Health, RePORTER application 10324450, Electrical stimulation to reduce pain and improve function after knee replacement (2R44AG052196-04A1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10324450. Licensed CC0.

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