Clinical trial NCT04670042: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: 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
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: SPR Therapeutics, Inc.
First posted: 2020-12-17
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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)
Primary purpose: TREATMENT

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.


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.

  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

Primary outcomes:
measure: Change in Pain Intensity from Baseline to 12 Months
timeFrame: Collected at baseline, 10, 30, 60, and 90 days post lead placement; and 6 months following TKA
Secondary outcomes:
measure: Change in Opioid Use
timeFrame: Collected at baseline, 10, 30, 60, and 90 days post lead placement; and 6 months following TKA
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford Pain Management Center
state: California
Study officials:
affiliation: CLINICAL ASSOCIATE PROFESSOR, ANESTHESIOLOGY, PERIOPERATIVE AND PAIN MEDICINE
name: Einar Ottestad
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.