Using Peripheral Nerve Stimulation (PNS) to Treat Chronic Post-surgical Pain (CPSP) After Knee Surgery

Surgery Clinical Trial

Official title:

Feasibility and Effectiveness of Using Peripheral Nerve Stimulation (PNS) to Treat Chronic Post-surgical Pain (CPSP) Following Total Knee Arthroplasty.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04670042
• Other study ID #: 58819
• Status: Withdrawn
• Phase: N/A
• Start date: June 25, 2021
• Est. completion date: May 2024

Study information

• Verified date: October 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

SPRINT PNS System will be offered to patients with postoperative knee pain following primary unilateral total knee arthroplasty (TKA) who meet eligibility criteria and consistent with established coverage policy. SPRINT PNS System will be implanted for 60 days. At the discretion of the physician, the first lead may be placed to stimulate the nerve innervating the region of greatest pain. If pain is not adequately addressed by the first lead when assessed at 10 days, a second lead may be placed approximately 2 weeks following the initial lead placement.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2024
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• At least 21 years old
• Underwent a primary or revision unilateral TKA
• Completed all CHOIR questionnaires before and after TKA surgery
• Persistent postsurgical knee pain = 5 of 10 during ambulation as demonstrated on the CHOIR assessment.
• Must meet the definition of chronic pain.

1. Pain that continues or is expected to continue for longer than 3 months from its initial onset or

2. Persistent pain that at the discretion of the physician has not resolved within the normal time course of healing or

3. Pain requiring opioid use beyond 30 days.

Exclusion Criteria:

• Patients with a pre-operative history of moderate to high dose use of opioids (= 50 morphine milligram equivalents (MME) average per day)
• Patients taking opioids for reasons other than pain in knee that underwent TKA
• Patients with arthrofibrosis or indicated for manipulation under anesthesia
• BMI >35
• Uncontrolled Diabetes Mellitus Types I or II, indicated by an HbA1c >7.0% within the last 3 months
• Vulnerable population (e.g. pregnant women, prisoners, minors, or employees)
• Deep brain stimulation (DBS) system, an implanted active cardiac implant, or any other implantable neurostimulator whose stimulus current pathway may overlap the SPRINT stimulator's current pathway.
• Any other condition that may interfere with the ability to participate in a clinical trial (e.g., anatomy that may interfere with lead placement, nerve damage in affected leg, pain caused by knee implant requiring revision, compromised immune system) as determined by the Investigator
• Workers Compensation

Related Conditions & MeSH terms

• Chronic Post-Procedural Pain
• Chronic Postoperative Pain
• Injury; Nerve, Peripheral, Multiple
• Knee Injuries
• Knee Pain Chronic
• Pain, Postoperative
• Pain, Procedural
• Peripheral Nerve Injuries
• Postoperative Pain
• Surgery
• Total Knee Arthroplasty
• Wounds and Injuries

Intervention

Device:
• SPRINT® Peripheral Nerve Stimulation (PNS) System (510k Cleared)
Same as Arm Description.

Locations

Country	Name	City	State
United States	Stanford Pain Management Center	Redwood City	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	SPR Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (5)

Gilmore C, Ilfeld B, Rosenow J, Li S, Desai M, Hunter C, Rauck R, Kapural L, Nader A, Mak J, Cohen S, Crosby N, Boggs J. Percutaneous peripheral nerve stimulation for the treatment of chronic neuropathic postamputation pain: a multicenter, randomized, placebo-controlled trial. Reg Anesth Pain Med. 2019 Jun;44(6):637-645. doi: 10.1136/rapm-2018-100109. Epub 2019 Apr 5. — View Citation

Ilfeld BM, Ball ST, Gabriel RA, Sztain JF, Monahan AM, Abramson WB, Khatibi B, Said ET, Parekh J, Grant SA, Wongsarnpigoon A, Boggs JW. A Feasibility Study of Percutaneous Peripheral Nerve Stimulation for the Treatment of Postoperative Pain Following Total Knee Arthroplasty. Neuromodulation. 2019 Jul;22(5):653-660. doi: 10.1111/ner.12790. Epub 2018 Jul 19. — View Citation

Ilfeld BM, Gabriel RA, Said ET, Monahan AM, Sztain JF, Abramson WB, Khatibi B, Finneran JJ 4th, Jaeger PT, Schwartz AK, Ahmed SS. Ultrasound-Guided Percutaneous Peripheral Nerve Stimulation: Neuromodulation of the Sciatic Nerve for Postoperative Analgesia Following Ambulatory Foot Surgery, a Proof-of-Concept Study. Reg Anesth Pain Med. 2018 Aug;43(6):580-589. doi: 10.1097/AAP.0000000000000819. — View Citation

Ilfeld BM, Gilmore CA, Grant SA, Bolognesi MP, Del Gaizo DJ, Wongsarnpigoon A, Boggs JW. Ultrasound-guided percutaneous peripheral nerve stimulation for analgesia following total knee arthroplasty: a prospective feasibility study. J Orthop Surg Res. 2017 Jan 13;12(1):4. doi: 10.1186/s13018-016-0506-7. — View Citation

Ilfeld BM, Said ET, Finneran JJ 4th, Sztain JF, Abramson WB, Gabriel RA, Khatibi B, Swisher MW, Jaeger P, Covey DC, Robertson CM. Ultrasound-Guided Percutaneous Peripheral Nerve Stimulation: Neuromodulation of the Femoral Nerve for Postoperative Analgesia Following Ambulatory Anterior Cruciate Ligament Reconstruction: A Proof of Concept Study. Neuromodulation. 2019 Jul;22(5):621-629. doi: 10.1111/ner.12851. Epub 2018 Aug 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pain Intensity from Baseline to 12 Months	The primary outcome is Pain Intensity using Numerical Rating Scale (NRS) from 0-10 with the higher number (10) being worse pain and (0) being no pain.; Incidence of chronic post-surgical pain (CPSP) through Pain Intensity will be looked at for patients throughout the study along with usage of the Peripheral Nerve Stimulation (PNS) device (hours/day).; A collection of surveys already approved for patients following total knee arthroplasty from Stanford's Collaborative Health Outcomes Information Registry (CHOIR) will also be sent to patients.	Collected at baseline, 10, 30, 60, and 90 days post lead placement; and 6 months following TKA
Secondary	Change in Opioid Use	Opioid use as documented in the medical records and patient-reported.; Will note the increase, decrease, or no change in opioid associated with implantation of the study device.	Collected at baseline, 10, 30, 60, and 90 days post lead placement; and 6 months following TKA

External Links

•   Peripheral Nerve Stimulator Device Website