Osteoarthritis, KneeNCT06152029
Temporary Peripheral Nerve Stimulation System for Osteoarthritis of the Knee
An observational study of Osteoarthritis, Knee and Osteoarthritis, run by Wake Forest University Health Sciences at 2 sites in United States.
Trial summary
The purpose of this study is to demonstrate the treatment outcomes of patients with chronic knee pain secondary to osteoarthritis that have received a temporary peripheral nerve stimulation system. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Osteoarthritis, Knee, Osteoarthritis
- What is being tested?
- Temporary PNS system
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Nov 2023to 20 Oct 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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
Study population: Study population includes patients with chronic knee pain secondary to osteoarthritis of the knee and will receive a temporary peripheral nerve stimulation device.
Who may be able to join
- Age of 21 and older
- Will receive a temporary PNS system for the management of chronic knee pain secondary to osteoarthritis
- Be capable of subjective evaluation, able to read and understand English-written questionnaires, and able to read, understand and sign the written informed consent in English
- Be willing and capable of giving informed consent
- Be willing and able to comply with study-related requirements, procedures, and scheduled visits
Who cannot join
- No knee pain at rest
- Same nerve targeted for both Radiofrequency Ablation (RFA) and Peripheral Nerve Stimulation (PNS) in less than 6 months post RFA, if applicable
- Pregnancy
- History of repetitive skin infections
- Vulnerable populations (e.g., prisoners, minors, students, employees)
- 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, compromised immune system, uncontrolled diabetes)
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- Confounding conditions such as lumbar radiculopathy
- Deep brain stimulation system, implanted active cardiac implant (e.g. pacemaker of defibrillator), or any other implantable neuro-stimulator whose stimulus current pathway may overlap the SPRINT system.
- Be involved in an injury claim under current litigation
- Be a recipient of temporary Social Security Disability Insurance (SSDI) benefits due to chronic pain
- Have a pending or approved worker's compensation claim
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Aurora Health Center
Fond du Lac, Wisconsin, 54937
Aurora Health Oshkosh
Oshkosh, Wisconsin, 54914
About this study
Official title: Efficacy of a Temporary Peripheral Nerve Stimulation System in Patients With Osteoarthritis of the Knee
The purpose of this study is to demonstrate the treatment outcomes of patients with chronic knee pain secondary to osteoarthritis that have received a temporary peripheral nerve stimulation system.
- Conditions
- Osteoarthritis, Knee, Osteoarthritis
- Being tested
- Temporary PNS system
- Keywords
- Peripheral nerve stimulation, PNS
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporary PNS systemDevice
Also called SPRINT PNS System
This system remains in place up to 60 days, then removed.
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with a temporary PNS system | These patients will receive a temporary PNS system for their knee pain secondary to osteoarthritis Receives: Device: Temporary PNS system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average change from baseline to end of treatment in average pain intensity measured through BPI-SF item 5.
Measured: up to 60 days post lead placement
Secondary outcomes (10)
Average change from baseline to end of treatment in health-related quality of life measured through PROMIS-29.
Measured: up to 60 days post lead placement
Average change from baseline to end of treatment in pain interference measured through BPI-SF.
Measured: up to 60 days post lead placement
Average change in chronic pain related medication intake at end of treatment compared to baseline in Morphine Miligram Equivalents (MME)
Measured: up to 60 days post lead placement
Overall patient global impression of change (PGIC) at end of treatment.
Measured: up to 60 days post lead placement
Overall incidence of lead migration/fracture at the end of treatment.
Measured: up to 60 days post lead placement
Average change from baseline to 7- and 30-days post-implant; and 6- and 12-months post-explant in average pain intensity measured through BPI-SF item 5.
Measured: 7 and 30 days post lead placement; and 6 and 12 month post lead pull
Average change from baseline to 6- and 12-months post-explant in health-related quality of life measured through PROMIS-29.
Measured: 7 and 30 days post lead placement; and 6 and 12 month post lead pull
Average change from baseline to 6- and 12-months post-explant in pain interference measured through BPI-SF.
Measured: 7 and 30 days post lead placement; and 6 and 12 month post lead pull
Overall patient global impression of change (PGIC) at 6 months and end of study.
Measured: 6 and 12 months post lead pull
Overall incidence of lead migration/fracture during the study.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start15 Nov 2023
- Primary completion20 Oct 2025
- Study completion20 Oct 2025
Why it stopped: Principal Investigator left Advocate Health
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Littlefield Lauren, MD, Principal investigator, Aurora Medical Center Oshkosh - 855 N Westhaven Dr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06152029
- Sponsor's protocol ID
- IRB00104845
- Other IDs
- 23.135E
- Status last verified
- Nov 2025
- First submitted
- 15 Nov 2023
- Last updated
- 6 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Temporary Peripheral Nerve Stimulation System in Patients With Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT06152029
- Acronym / sponsor ID
- IRB00104845
- Conditions
- Osteoarthritis, Knee, Osteoarthritis
- Keywords
- Peripheral nerve stimulation, PNS
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Principal Investigator left Advocate Health
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 20 Oct 2025 (actual)
- Study completion
- 20 Oct 2025 (actual)
- First posted
- 30 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to demonstrate the treatment outcomes of patients with chronic knee pain secondary to osteoarthritis that have received a temporary peripheral nerve stimulation system.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with a temporary PNS system | – | Device: Temporary PNS systemThese patients will receive a temporary PNS system for their knee pain secondary to osteoarthritis |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population includes patients with chronic knee pain secondary to osteoarthritis of the knee and will receive a temporary peripheral nerve stimulation device.
Key inclusion criteria (5 listed)
- Age of 21 and older
- Will receive a temporary PNS system for the management of chronic knee pain secondary to osteoarthritis
- Be capable of subjective evaluation, able to read and understand English-written questionnaires, and able to read, understand and sign the written informed consent in English
- Be willing and capable of giving informed consent
- Be willing and able to comply with study-related requirements, procedures, and scheduled visits
Key exclusion criteria (11 listed)
- No knee pain at rest
- Same nerve targeted for both Radiofrequency Ablation (RFA) and Peripheral Nerve Stimulation (PNS) in less than 6 months post RFA, if applicable
- Pregnancy
- History of repetitive skin infections
- Vulnerable populations (e.g., prisoners, minors, students, employees)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Temporary PNS systemAlso: SPRINT PNS SystemThis system remains in place up to 60 days, then removed. | Device | Patients treated with a temporary PNS system |
Primary outcome
Average change from baseline to end of treatment in average pain intensity measured through BPI-SF item 5.
Time frame: up to 60 days post lead placement
10 secondary outcomes
Average change from baseline to end of treatment in health-related quality of life measured through PROMIS-29.
Time frame: up to 60 days post lead placement
Average change from baseline to end of treatment in pain interference measured through BPI-SF.
Time frame: up to 60 days post lead placement
Average change in chronic pain related medication intake at end of treatment compared to baseline in Morphine Miligram Equivalents (MME)
Time frame: up to 60 days post lead placement
Overall patient global impression of change (PGIC) at end of treatment.
Time frame: up to 60 days post lead placement
Overall incidence of lead migration/fracture at the end of treatment.
Time frame: up to 60 days post lead placement
Average change from baseline to 7- and 30-days post-implant; and 6- and 12-months post-explant in average pain intensity measured through BPI-SF item 5.
Time frame: 7 and 30 days post lead placement; and 6 and 12 month post lead pull
Average change from baseline to 6- and 12-months post-explant in health-related quality of life measured through PROMIS-29.
Time frame: 7 and 30 days post lead placement; and 6 and 12 month post lead pull
Average change from baseline to 6- and 12-months post-explant in pain interference measured through BPI-SF.
Time frame: 7 and 30 days post lead placement; and 6 and 12 month post lead pull
Overall patient global impression of change (PGIC) at 6 months and end of study.
Time frame: 6 and 12 months post lead pull
Overall incidence of lead migration/fracture during the study.
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Principal Investigator left Advocate Health). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Littlefield Lauren, MD principal investigator
Aurora Medical Center Oshkosh - 855 N Westhaven Dr
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee and Osteoarthritis, run by Wake Forest University Health Sciences at 2 sites 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 5 inclusion and 11 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: stopped early, as of the sponsor's last update on 6 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 stopped early (reason given: Principal Investigator left Advocate Health). Results are not available in the source record.
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?
Average change from baseline to end of treatment in average pain intensity measured through BPI-SF item 5. (time frame: up to 60 days post lead placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Nov 2025.