Background & Aims

Total knee arthroplasty (TKA) is an effective surgical procedure used to treat end-stage knee osteoarthritis. Despite positive results for most patients, approximately 10-20% of patients continue to experience persistent postoperative pain following TKA [1, 2]. Furthermore, patients may continue to experience adverse outcomes due to limited mobility and reduced function and quality of life [3-5]. Percutaneous peripheral nerve stimulation (PNS) has shown promising results as a non-opioid treatment for acute and persistent (chronic) postoperative pain [6-8]. The primary aim of the present study was to evaluate the treatment of persistent postoperative pain after knee replacement surgery with 60-day percutaneous PNS in a multicenter, randomized, double-blind, placebo-controlled trial. Additional aims included determining if 60-day percutaneous PNS improves function and walking ability for patients with postoperative pain.

Methods

Participants were included if they reported persistent moderate to severe baseline pain (average daily pain ?5 out of 10 across 7 days and stable for 2-weeks; brief pain inventory short form [BPI-SF] question #5) with stable medication usage for 4 weeks prior to enrollment. Subjects were randomized to receive either active PNS or placebo (sham) stimulation. Subjects and a designated evaluator were blinded to group assignments. Subjects underwent ultrasound-guided placement of percutaneous fine-wire coiled leads to target the femoral and sciatic nerves on the leg with postoperative pain. Treatment lasted for 8 weeks, and the primary efficacy outcome compared the proportion of subjects in each group reporting ?50% reduction in average pain relative to baseline during weeks 5-8. Functional outcomes, including an objective functional outcome (six-minute walk test; 6MWT), were also evaluated at the end of treatment (EOT).

Results

Fifty-two subjects were randomized and received treatment, and 41 subjects (active PNS: n=20, placebo [sham]: n=21) reported data during the primary endpoint period (weeks 5-8). A significantly greater proportion of PNS subjects (60%; 12/20) compared to placebo subjects (24%; 5/21) responded with ?50% pain relief during the primary endpoint (p=0.028). Mean pain relief was also significantly higher in the PNS subjects compared to placebo subjects during the primary endpoint (54 vs. 26%, respectively; p=0.0021). Furthermore, pain relief continued out to 3 months after the start of treatment (49 vs. 28% for PNS vs. placebo, respectively; p=0.045). Additionally, PNS subjects exhibited a significant increase in distance walked at EOT compared to placebo subjects (6MWT; 47% vs. -9% change from baseline; p=0.048; n=18 vs. 20 subjects completed test, respectively). All study-related adverse events were non-serious, requiring only minor treatment.

Conclusions

This multicenter, randomized, double-blind, placebo-controlled trial demonstrated pain relief and functional improvements following percutaneous PNS over a 60-day period as a minimally invasive, non-opioid treatment for persistent postoperative pain. Furthermore, pain relief in PNS subjects continued up to 3 months after start of treatment (1 month after EOT), demonstrating the potential for durable improvements even after EOT. Percutaneous PNS also promoted increased mobility and function during treatment, which may be beneficial for patients with disabling pain, decreased mobility and functional deficits following TKA.

References

Support for this study was provided by the Department of Defense (CDMRP/PRORP W81XWH-18-1-0799).
[1]A. Barke and B. Korwisi, “Making chronic pain count: empirical support for the ICD-11 classification of chronic pain,” Curr Opin Anaesthesiol, vol. 36, no. 5, pp. 589-594, Oct 1 2023, doi: 10.1097/ACO.0000000000001297.
[2]R. D. Treede et al., “A classification of chronic pain for ICD-11,” Pain, vol. 156, no. 6, pp. 1003-1007, Jun 2015, doi: 10.1097/j.pain.0000000000000160.
[3]V. Wylde, A. Beswick, J. Bruce, A. Blom, N. Howells, and R. Gooberman-Hill, “Chronic pain after total knee arthroplasty,” EFORT Open Rev, vol. 3, no. 8, pp. 461-470, Aug 2018, doi: 10.1302/2058-5241.3.180004.
[4]Y. Sugiyama et al., “Prevalence of chronic postsurgical pain after thoracotomy and total knee arthroplasty: a retrospective multicenter study in Japan (Japanese Study Group of Subacute Postoperative Pain),” J Anesth, vol. 32, no. 3, pp. 434-438, Jun 2018, doi: 10.1007/s00540-018-2481-0.
[5]D. H. Kim, K. M. Pearson-Chauhan, R. J. McCarthy, and A. Buvanendran, “Predictive Factors for Developing Chronic Pain After Total Knee Arthroplasty,” J Arthroplasty, vol. 33, no. 11, pp. 3372-3378, Nov 2018, doi: 10.1016/j.arth.2018.07.028.
[6]B. M. Ilfeld et al., “Percutaneous Peripheral Nerve Stimulation to Control Postoperative Pain, Decrease Opioid Use, and Accelerate Functional Recovery Following Orthopedic Trauma,” Mil Med, vol. 184, no. Suppl 1, pp. 557-564, Mar 1 2019, doi: 10.1093/milmed/usy378.
[7]C. Gilmore et al., “Percutaneous peripheral nerve stimulation for the treatment of chronic neuropathic postamputation pain: a multicenter, randomized, placebo-controlled trial,” Reg Anesth Pain Med, vol. 44, no. 6, pp. 637-645, Jun 2019, doi: 10.1136/rapm-2018-100109.
[8]B. M. Ilfeld et al., “Percutaneous Peripheral Nerve Stimulation (Neuromodulation) for Postoperative Pain: A Randomized, Sham-controlled Pilot Study,” Anesthesiology, vol. 135, no. 1, pp. 95-110, 2021.
[9]E. Amirianfar, R. Rosales, A. Logan, T. L. Doshi, J. Reynolds, and C. Price, “Peripheral nerve stimulation for chronic knee pain following total knee arthroplasty: a systematic review,” Pain Management, no. 0, 2023.
[10]B. M. Ilfeld et al., “A Feasibility Study of Percutaneous Peripheral Nerve Stimulation for the Treatment of Postoperative Pain Following Total Knee Arthroplasty,” Neuromodulation, vol. 22, no. 5, pp. 653-660, Jul 2018, doi: 10.1111/ner.12790.
[11]B. Albright-Trainer et al., “Peripheral nerve stimulation for the management of acute and subacute post-amputation pain: a randomized, controlled feasibility trial,” Pain Manag, vol. 12, no. 3, pp. 357-369, Apr 2022, doi: 10.2217/pmt-2021-0087.

Presenting Author

David Dickerson

Poster Authors

John Gilbert

PhD

SPR Therapeutics

Lead Author

E-mail

David Dickerson

MD

Endeavor Health, The University of Chicago

Lead Author

E-mail

Johnathan Goree

MD

University of Arkansas for Medical Sciences

Lead Author

E-mail

Stuart Grant

MD

University of North Carolina School of Medicine

Lead Author

E-mail

Brian Ilfeld

MD

University of California San Diego

Lead Author

E-mail

Yashar Eshraghi

MD

Ochsner Medical Center

Lead Author

E-mail

Sandeep Vaid

MD

Better Health Clinical Research

Lead Author

E-mail

Ali Valimahomed

MD

Gramercy Pain Center

Lead Author

E-mail

Jarna Shah

MD

University of Arkansas for Medical Sciences

Lead Author

E-mail

Lawson Smith

MD

University of Arkansas for Medical Sciences

Lead Author

E-mail

John Finneran

MD

University of California San Diego

Lead Author

E-mail

Nirav Shah

MD

Endeavor Health, The University of Chicago

Lead Author

E-mail

Maged Guirguis

MD

Ochsner Medical Center

Lead Author

E-mail

Maxim Eckmann

University of Texas San Antonio

Lead Author

E-mail

Ajay Antony

MD

The Orthopaedic Institute

Lead Author

E-mail

Brian Ohlendorf

MD

Duke University

Lead Author

E-mail

Mayank Gupta

MD

Neuroscience Research Center

Lead Author

E-mail

John Gilbert

PhD

SPR Therapeutics

Lead Author

E-mail

Amorn Wongsarnpigoon

PhD

SPR Therapeutics

Lead Author

E-mail

Joseph Boggs

PhD

SPR Therapeutics

Lead Author

E-mail

Topics

  • Specific Pain Conditions/Pain in Specific Populations: Post-surgical/Post-traumatic Chronic Pain

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