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Injury; Nerve, Peripheral, MultipleNCT04670042

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

A study testing SPRINT® Peripheral Nerve Stimulation (PNS) System (510k Cleared) in people with Injury; Nerve, Peripheral, Multiple and Chronic Post-Procedural Pain, run by Stanford University at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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. Read more about this study

Who is it for?
Ages 21 years and older
What is being tested?
SPRINT® Peripheral Nerve Stimulation (PNS) System (510k Cleared)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
25 Jun 2021to May 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stanford Pain Management Center

    Redwood City, California, 94063

Other trials in United States

About this study

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

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.

Being tested
SPRINT® Peripheral Nerve Stimulation (PNS) System (510k Cleared)
Keywords
Chronic Pain Following Left Total Knee Arthroplasty, Chronic Pain Following Right Total Knee Arthroplasty
Medical subject headings
Wounds and Injuries, Knee Injuries, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SPRINT® Peripheral Nerve Stimulation (PNS) System (510k Cleared)Device

    Same as Arm Description.

Study groups in NCT04670042
Study groupRoleWhat they receive
SPRINT® Peripheral Nerve Stimulation (PNS) SystemExperimentalSPRINT 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.
Receives: Device: SPRINT® Peripheral Nerve Stimulation (PNS) System (510k Cleared)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Collected at baseline, 10, 30, 60, and 90 days post lead placement; and 6 months following TKA

Secondary outcomes (1)

  1. 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.

    Measured: Collected at baseline, 10, 30, 60, and 90 days post lead placement; and 6 months following TKA

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2020
  2. Study start25 Jun 2021
  3. Primary completionAug 2022 (estimated)
  4. Study completionMay 2024 (estimated)

Why it stopped: Difficulty enrolling in this patient population

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
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)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04670042
Sponsor's protocol ID
58819
Status last verified
Oct 2022
First submitted
11 Nov 2020
Last updated
20 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: Not Sharing.

Publications

  • 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.

    PubMed 30954936

  • 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.

    PubMed 30160335

  • 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.

    PubMed 29905630

  • 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.

    PubMed 28086940

  • 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.

    PubMed 30024078

Questions about this trial

What is this clinical trial studying?

A study testing SPRINT® Peripheral Nerve Stimulation (PNS) System (510k Cleared) in people with Injury; Nerve, Peripheral, Multiple and Chronic Post-Procedural Pain, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 20 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Pain Intensity from Baseline to 12 Months (time frame: Collected at baseline, 10, 30, 60, and 90 days post lead placement; and 6 months following TKA). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04670042, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2022.

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