MiniStim PNS for Chronic Knee Pain

Overseen By Marlene Pena

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: MiniStim LLC

Disqualifiers: Pregnancy, Active implantable device, others

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 36 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called Moventis PNS (Peripheral Nerve Stimulation) for individuals with chronic knee pain. The aim is to determine if this device can reduce knee pain by more than half without increasing pain medication use. Participants are divided into two groups: one receives immediate therapy, while the other begins after three months. This trial may suit those who have experienced knee pain limiting daily activities for at least three months and have found temporary relief from specific nerve tests. As an unphased trial, it provides a unique opportunity to access innovative treatment options that could significantly enhance quality of life.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that pain relief is measured without increasing baseline pain medications, so you may need to maintain your current dosage.

What prior data suggests that this device is safe for chronic knee pain?

Research has shown that peripheral nerve stimulation (PNS), such as the Moventis PNS used in this trial, is generally safe for treating long-term knee pain. Studies have found that most side effects are minor, meaning they are usually not serious and can often be managed easily.

Additional research supports PNS as a safe option that doesn't involve major surgery. "Minimally invasive" means it doesn't require cutting deeply into the body. This is reassuring for those considering joining the trial, as it suggests a lower risk compared to more invasive procedures.

In summary, Moventis PNS is generally well-tolerated, with few serious side effects reported in studies. This makes it a promising option for safely managing long-term knee pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for chronic knee pain, which often rely on medications like NSAIDs or corticosteroid injections, Moventis PNS offers a non-drug approach using Peripheral Nerve Stimulation (PNS). This technique specifically targets nerves associated with knee pain, potentially providing relief without the side effects common in pharmacological treatments. Researchers are excited about this treatment because it allows for direct modulation of pain pathways, offering a promising alternative for those who may not respond well to standard care or are looking for opioid-free pain management options.

What evidence suggests that this device is effective for chronic knee pain?

Research has shown that Peripheral Nerve Stimulation (PNS) effectively alleviates long-lasting knee pain. In one study, 94.4% of patients experienced at least a 50% reduction in pain after PNS treatment. Another study highlighted the lasting benefits of PNS for managing knee pain. In this trial, participants in the Active group will receive Moventis PNS therapy, which could significantly reduce chronic knee pain without additional medication. This treatment appears promising for providing substantial pain relief for individuals with this condition. ^{3 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with chronic knee pain lasting at least three months, a VAS score above 5, and who've had temporary relief from nerve diagnostics. Candidates must be able to give consent, follow procedures, operate the device, and not have had recent knee surgery or anatomical issues affecting device placement.

Inclusion Criteria

I. Appropriate candidate for the implant procedure based on the opinion of investigator.

Baseline VAS score of > 5

You are experiencing pain that is rated above 5 on a visual analog scale.

Exclusion Criteria

Deemed unsuitable for enrollment by investigator based on medical history or physical examination.

Have a life expectancy of less than 1-year

Worker's compensation claimants

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive MiniStim PNS therapy, with active group starting immediately and delayed group starting at 3-month visit

36 months

Regular visits every 3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 months

Visits at 3, 6, 9, 12, 24, and 36 months

What Are the Treatments Tested in This Trial?

Interventions

• Moventis PNS

Trial Overview

The 'FLEX' study tests the MiniStim PNS on individuals with chronic knee pain. Participants are randomly assigned to receive active therapy immediately or after a three-month delay. Pain relief without increased medication is measured at several intervals up to 36 months.

How Is the Trial Designed?

Group I: Active Active Control 1 Intervention

Subjects randomized to the Active group, programming parameters will be set, and therapy will be delivered for a minimum of 2-hours per day for the duration of the study.

Group II: Delayed Placebo Group 1 Intervention

The delayed group will begin 2-hour stimulation/day at the 3-Month visit.

Moventis PNS is already approved in United States for the following indications:

Approved in United States as MiniStim PNS for:

• Chronic knee pain
• Chronic musculoskeletal pain

Who Is Running the Clinical Trial?

MiniStim LLC

Lead Sponsor

Trials

1

Recruited

350+

Micron Medical Corporation

Lead Sponsor

Trials

5

Recruited

860+

Uro Medical Corporation

Lead Sponsor

Trials

6

Recruited

870+

Published Research Related to This Trial

In a study of 12 patients with peripheral neuropathic pain (PNP), short-term peripheral nerve stimulation (PNS) significantly reduced pain levels by an average of 85.5% after six treatments, indicating strong efficacy for managing PNP symptoms.

The PNS procedure was found to be safe, with no serious adverse events reported, suggesting it could be a viable treatment option for individuals suffering from PNP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical stimulation of the posterior tibial nerve reduces neuropathic pain in patients with polyneuropathy. Dabby, R., Sadeh, M., Goldberg, I., et al.[2023]

In a retrospective study of 46 patients with painful nerve injuries, peripheral nerve stimulation (PNS) provided good pain relief (50% or more reduction) in 78% of cases over a follow-up period of 3 to 16 years.

The average pain intensity significantly decreased from a visual analog scale (VAS) score of 69 before surgery to 24 after PNS, indicating that PNS is an effective long-term treatment option for selected patients with isolated painful neuropathies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term peripheral nerve stimulation for painful nerve injuries. Eisenberg, E., Waisbrod, H., Gerbershagen, HU.[2019]

A pilot study involving six patients demonstrated that a novel, wirelessly controlled microstimulator for tibial nerve stimulation significantly reduced pain levels in patients with peripheral neuropathic pain (PNP) and complex regional pain syndrome (CRPS) over a six-month period, with visual analog scale (VAS) scores dropping from an average of 7.5 preoperatively to 1.3 at six months (p=0.02).

The treatment was found to be safe and minimally invasive, with no complications reported, indicating that intermittent tibial nerve stimulation could be a feasible option for managing chronic pain conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tibial nerve stimulation with a miniature, wireless stimulator in chronic peripheral neuropathic pain. Sokal, P., Harat, M., Zieliński, P., et al.[2020]

Peripheral nerve stimulation (PNS) has gained significant acceptance in treating chronic pain, with recent multicenter studies leading to its approval in Europe for chronic low back pain and intractable migraines.

The article aims to provide an updated overview of PNS, highlighting its safety and efficacy, as well as the need for further evidence to support its global regulatory approval and optimize treatment parameters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An update on peripheral nerve stimulation. Rasskazoff, SY., Slavin, KV.[2017]

Peripheral nerve stimulation (PNS) is an effective technique for managing various types of chronic and acute pain by using electrical stimulation to inhibit pain signal transmission in both central and peripheral pathways.

PNS works by inhibiting specific pain fibers in the central nervous system and downregulating inflammatory mediators and neurotransmitters involved in pain signaling, making it a versatile option for treating conditions like post-surgical pain, headaches, and phantom limb pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanism of Action of Temporary Peripheral Nerve Stimulation. Abd-Elsayed, A., Attanti, S., Anderson, M., et al.[2023]

The novel 'sandwich' technique for peripheral nerve stimulation (PNS) involves placing two paddle leads on either side of a nerve, enhancing contact with nerve fibers and potentially improving pain relief outcomes.

This method reduces the risk of lead migration and allows for better stimulation through 'crosstalk,' making it a promising option for chronic pain management with minimal additional risk to patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peripheral nerve stimulation by 'sandwich' paddle leads: technical note. Amit, A., Sharma, M., Deogaonkar, M.[2018]

A patient with severe knee pain from osteoarthritis experienced significant pain relief through peripheral nerve stimulation (PNS) targeting the superior lateral genicular nerve and the saphenous nerve, despite refusing surgery and radiofrequency ablation.

This case highlights PNS as a potential effective alternative treatment for chronic knee pain, particularly for patients who do not wish to undergo more invasive procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peripheral Stimulation of the Saphenous and Superior Lateral Genicular Nerves for Chronic Knee Pain. Hasoon, J., Chitneni, A., Urits, I., et al.[2021]

In a study of 15 patients with chronic pelvic pain, 60% experienced more than a 50% reduction in pain after 12 weeks of intermittent percutaneous posterior tibial nerve stimulation (PTNS), indicating its potential efficacy in pain management.

The average pain score decreased significantly from 8.1 to 4.1, showing that PTNS can effectively reduce pain levels, although it did not significantly improve other urinary symptoms measured by the International Prostate Symptom Score.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous posterior tibial nerve stimulation in patients with chronic pelvic pain: a preliminary study. Kim, SW., Paick, JS., Ku, JH.[2006]

Percutaneous electrical nerve stimulation is a non-invasive technique that effectively evaluates neuromuscular function from the brain to the muscles by stimulating the posterior tibial nerve and recording responses through electromyography.

This method allows researchers to assess neuromuscular transmission, spinal excitability, and voluntary activation levels, making it particularly useful for studying neuromuscular changes due to exercise fatigue or training adaptations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of Neuromuscular Function Using Percutaneous Electrical Nerve Stimulation. Rozand, V., Grosprêtre, S., Stapley, PJ., et al.[2018]

Peripheral nerve stimulation (PNS) shows level II evidence for effectively treating refractory peripheral nerve injury, with about two-thirds of patients experiencing at least 50% sustained pain relief, based on a systematic review of 102 studies.

PNS has a safety advantage over spinal cord stimulation, as it carries no risk of central cord injury, and adverse events are generally minor, making it a promising option for pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peripheral Nerve Stimulation for Chronic Pain: A Systematic Review of Effectiveness and Safety. Helm, S., Shirsat, N., Calodney, A., et al.[2023]

Citations

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Peripheral Nerve Stimulation in Chronic Knee Pain

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Gilmore et al (2019) reported the 12-month results of their study to evaluate the long-term efficacy of a 60-day PNS treatment for chronic post- ...

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MiniStim PNS for Chronic Knee Pain

Peripheral nerve stimulation (PNS) is generally considered safe, with most adverse events being minor. Studies have shown it to be a safe, minimally invasive ...

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Moventis PNS is indicated for pain management in adults ... Implantable peripheral nerve stimulation (PNS) devices for the treatment of chronic pain are.