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

Primary Purpose

Injury; Nerve, Peripheral, Multiple, Chronic Post-Procedural Pain, Total Knee Arthroplasty

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SPRINT® Peripheral Nerve Stimulation (PNS) System (510k Cleared)
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Injury; Nerve, Peripheral, Multiple focused on measuring Chronic Pain Following Left Total Knee Arthroplasty, Chronic Pain Following Right Total Knee Arthroplasty

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford Pain Management Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SPRINT® Peripheral Nerve Stimulation (PNS) System

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
November 11, 2020
Last Updated
October 18, 2022
Sponsor
Stanford University
Collaborators
SPR Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04670042
Brief Title
Using Peripheral Nerve Stimulation (PNS) to Treat Chronic Post-surgical Pain (CPSP) After Knee Surgery
Official Title
Feasibility and Effectiveness of Using Peripheral Nerve Stimulation (PNS) to Treat Chronic Post-surgical Pain (CPSP) Following Total Knee Arthroplasty.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Difficulty enrolling in this patient population
Study Start Date
June 25, 2021 (Actual)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
SPR Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Injury; Nerve, Peripheral, Multiple, Chronic Post-Procedural Pain, Total Knee Arthroplasty, Surgery, Knee Injuries, Knee Pain Chronic, Postoperative Pain, Chronic Postoperative Pain
Keywords
Chronic Pain Following Left Total Knee Arthroplasty, Chronic Pain Following Right Total Knee Arthroplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Case series of 15 subjects with chronic post-surgical pain (CPSP). Subjects will be recruited over 6 months (on average 1 subject per week)
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SPRINT® Peripheral Nerve Stimulation (PNS) System
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
SPRINT® Peripheral Nerve Stimulation (PNS) System (510k Cleared)
Intervention Description
Same as Arm Description.
Primary Outcome Measure Information:
Title
Change in Pain Intensity from Baseline to 12 Months
Description
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.
Time Frame
Collected at baseline, 10, 30, 60, and 90 days post lead placement; and 6 months following TKA
Secondary Outcome Measure Information:
Title
Change in Opioid Use
Description
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.
Time Frame
Collected at baseline, 10, 30, 60, and 90 days post lead placement; and 6 months following TKA

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. Pain that continues or is expected to continue for longer than 3 months from its initial onset or Persistent pain that at the discretion of the physician has not resolved within the normal time course of healing or 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Einar Ottestad
Organizational Affiliation
CLINICAL ASSOCIATE PROFESSOR, ANESTHESIOLOGY, PERIOPERATIVE AND PAIN MEDICINE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Pain Management Center
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Not Sharing.
Citations:
PubMed Identifier
30954936
Citation
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.
Results Reference
background
PubMed Identifier
30160335
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.
Results Reference
background
PubMed Identifier
29905630
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.
Results Reference
background
PubMed Identifier
28086940
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.
Results Reference
background
PubMed Identifier
30024078
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.
Results Reference
background
Links:
URL
https://www.sprtherapeutics.com/
Description
Peripheral Nerve Stimulator Device Website

Learn more about this trial

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

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