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

350 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a prospective, multi-center, randomized, study in which 300 evaluable subjects will be randomized 1:1 to receive active or delayed therapy with Moments PNS. Subjects in the Delayed group will start with therapy at 3-month visit follow up. The primary endpoint is a \>50% pain relief at 3-months as measured by the Visual Analog Scale (VAS) without increase in baseline pain medications, with additional measurements assessed at 3, 6, 9, 12, 24, and 36-months.

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 data supports the effectiveness of the treatment Moventis PNS, MiniStim PNS, Moments PNS, Peripheral Nerve Stimulation for chronic knee pain?

Peripheral nerve stimulation (PNS) has been shown to effectively reduce pain in various conditions, including chronic knee pain and other types of chronic pain. In one case, a patient with severe knee pain from osteoarthritis experienced significant pain relief using PNS on specific knee nerves. Additionally, studies on similar PNS treatments for other types of pain, like peripheral neuropathic pain, have shown substantial pain reduction and improved quality of life. ^{1 2 3 4 5}

Is MiniStim PNS safe for treating 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 method for treating various types of chronic pain, although specific data for knee pain is not available. ^{1 2 6 7 8}

How is the MiniStim PNS treatment different from other treatments for chronic knee pain?

The MiniStim PNS treatment is unique because it uses electrical stimulation of peripheral nerves to block pain signals, offering a minimally invasive and convenient option for managing chronic knee pain. Unlike some other treatments, it is wirelessly controlled and can provide sustained pain relief without significant complications. ^{1 2 4 9 10}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Mechanism of Action of Temporary Peripheral Nerve Stimulation. [2023]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Tibial nerve stimulation with a miniature, wireless stimulator in chronic peripheral neuropathic pain. [2020]

3. Austria pubmed.ncbi.nlm.nih.gov

Peripheral nerve stimulation by 'sandwich' paddle leads: technical note. [2018]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Electrical stimulation of the posterior tibial nerve reduces neuropathic pain in patients with polyneuropathy. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Peripheral Stimulation of the Saphenous and Superior Lateral Genicular Nerves for Chronic Knee Pain. [2021]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Peripheral Nerve Stimulation for Chronic Pain: A Systematic Review of Effectiveness and Safety. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Long-term peripheral nerve stimulation for painful nerve injuries. [2019]

8. Italy pubmed.ncbi.nlm.nih.gov

An update on peripheral nerve stimulation. [2017]

9. United States pubmed.ncbi.nlm.nih.gov

Assessment of Neuromuscular Function Using Percutaneous Electrical Nerve Stimulation. [2018]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Percutaneous posterior tibial nerve stimulation in patients with chronic pelvic pain: a preliminary study. [2006]