Wireless Neuromodulation for Chronic Knee Pain

Recruiting at 19 trial locations

Overseen By Earl Kilbride, DO

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Curonix LLC

Disqualifiers: Grade IV osteoarthritis, Major depression, Renal insufficiency, Morbid obesity, others

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

Compensation: Varies

Number of Visits: 12

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new wireless device called Wireless Neuromodulation to determine its effectiveness in reducing chronic knee pain from osteoarthritis. Participants will receive either active stimulation from the device or a placebo (inactive version) for comparison. The goal is to assess whether this treatment can lower pain by at least 50% within a month. It suits individuals who have experienced troubling knee pain for over three months, have tried other treatments like physical therapy or injections without long-lasting relief, and have undergone surgeries such as a total knee replacement.

As an unphased trial, this study provides a unique opportunity for patients to explore innovative pain relief options.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should not have had recent invasive knee procedures like steroid injections within 2 weeks or other treatments like radiofrequency within 4 weeks before joining.

What prior data suggests that wireless neuromodulation is safe for treating chronic knee pain?

Research has shown that wireless neuromodulation, also known as peripheral nerve stimulation, is safe and generally well-tolerated. Studies have found that this method can effectively manage chronic pain in various body parts. It is less invasive than surgery, making it a safer choice for many people.

The Freedom Peripheral Nerve Stimulator System, a type of wireless neuromodulation, has already received approval for treating severe chronic pain, indicating it meets certain safety standards. Reports have demonstrated that this method can provide lasting pain relief for up to two years, supporting its safety and effectiveness for long-term use.

Overall, current research and past experiences with other conditions suggest that wireless neuromodulation is a safe option for those considering it for chronic knee pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Wireless neuromodulation is unique because it offers a non-invasive approach to managing chronic knee pain, unlike traditional treatments like medications or surgeries. This method uses wireless technology to stimulate nerves, potentially providing pain relief without the need for drugs or complex surgical procedures. Researchers are excited about this treatment because it targets pain differently, focusing on nerve modulation to reduce pain signals directly, which could lead to fewer side effects and a more personalized pain management solution.

What evidence suggests that wireless neuromodulation is effective for chronic knee pain?

Research has shown that wireless neuromodulation, which participants in this trial may receive, can help reduce chronic knee pain. In a similar approach called peripheral nerve stimulation, 94.4% of patients experienced at least 50% pain relief. Another study found that patients had an average pain reduction of about 54% after two months. This method has been used for various types of chronic pain and consistently reduces pain over time. These findings suggest that wireless neuromodulation could effectively manage chronic knee pain. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

Adults over 18 with chronic knee pain from osteoarthritis (Grade II or III), who've tried at least two other treatments like physical therapy or NSAIDs without success. Candidates should have had temporary relief from a nerve injection and be psychologically fit for implant therapies. Exclusions include severe psychiatric disorders, certain medical conditions, morbid obesity, and those with recent knee surgery.

Inclusion Criteria

I am over 18 years old.

I have chronic knee pain after a total knee replacement and am considered a good candidate for this procedure.

I understand this study and agree to participate.

Exclusion Criteria

My hip or foot hurts more than my knee.

I have pain in my knee, foot, or ankle that might interfere with the study.

I experience leg pain from walking due to nerve or blood vessel issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Diagnostic Injection

A diagnostic injection is performed to assess temporary pain relief

1 day

1 visit (in-person)

Trial Implant

Participants undergo a 7-day provisional test period with a trial stimulator

1 week

1 visit (in-person)

Permanent Implant

Permanent electrode implantation for those with >50% pain relief during trial

10 days inactive for healing

1 visit (in-person)

Randomization/Blinding

Participants are randomized to active or sham stimulation for up to 30 days

1 month

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

4 visits (in-person) at 1 week, 1 month, 3 months, and 6 months

Remote Follow-up

Remote follow-up calls to assess long-term pain relief and adverse events

24 months

3 remote visits at 12, 18, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Wireless neuromodulation

Trial Overview

The trial is testing wireless neuromodulation to relieve chronic knee pain in osteoarthritis patients. It compares the effects of active stimulation against no stimulation, focusing on significant pain reduction as measured by a visual scale after one month.

How Is the Trial Designed?

Group I: Interventional Experimental Treatment 1 Intervention

Single arm, active stimulation

Group II: Placebo Placebo Group 1 Intervention

When receiving sham stimulation, devices will be programmed to not actively deliver electrical stimulation but still deplete battery life to maintain blinding. Subjects will have to recharge batteries similar to receiving active stimulation. Sites will not have access to WaveCrest programmer. Study devices can only be programmed by Stimwave representatives.

Wireless neuromodulation is already approved in United States for the following indications:

Approved in United States as Curonix Freedom stimulators for:

• Chronic knee pain
• Knee osteoarthritis
• Total knee replacement cases

Who Is Running the Clinical Trial?

Curonix LLC

Lead Sponsor

Trials

9

Recruited

680+

Stimwave Technologies

Lead Sponsor

Trials

7

Recruited

440+

Florida Joint Pain Institute

Collaborator

Trials

1

Recruited

100+

Advanced Spine and Pain

Collaborator

Trials

1

Recruited

100+

Premier Pain Treatment

Collaborator

Trials

1

Recruited

100+

Austin Orthopedic Institute

Collaborator

Trials

1

Recruited

100+

Kettering Health

Collaborator

Trials

1

Recruited

100+

Desert Orthopaedic Institute

Collaborator

Trials

1

Recruited

100+

Vista Clinical Research

Collaborator

Trials

1

Recruited

100+

Southern pain and Spine

Collaborator

Trials

1

Recruited

100+

Published Research Related to This Trial

A 47-year-old woman with refractory upper extremity complex regional pain syndrome (CRPS I) experienced significant pain relief after treatment with wireless peripheral nerve stimulation (WPNS), reducing her pain from a visual analogue scale (VAS) score of 7 to 4 postoperatively.

The minimally invasive WPNS technique, which does not require battery implantation or extensive surgical procedures, was well-tolerated and led to improved sensory function, allowing the patient to resume driving and discontinue opioid use by the 5-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wireless peripheral nerve stimulation for complex regional pain syndrome type I of the upper extremity: a case illustration introducing a novel technology. Herschkowitz, D., Kubias, J.[2019]

Peripheral nerve stimulation (PNS) has rapidly evolved as a versatile treatment for various types of pain, utilizing percutaneous leads for easier and less invasive implantation since its introduction in 1999.

Current research is exploring PNS for broader applications beyond pain management, including conditions like epilepsy and obesity, with advancements in technology expected to enhance safety and accessibility for clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peripheral neuromodulation: a review. Goroszeniuk, T., Pang, D.[2021]

The study presents a novel ultra-thin, wireless, and battery-free brain implant designed for stimulating the motor cortex, which successfully triggered motor responses in 6 rodents during in vivo testing.

This implant, integrated with a flexible substrate and using wireless stimulation, eliminates the need for battery replacements or reprogramming, suggesting a significant advancement in long-term brain stimulation therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wireless Stimulation of Motor Cortex Through a Collagen Dura Substitute Using an Ultra-Thin Implant Fabricated on Parylene/PDMS. Benbuk, A., Gulick, D., Moniz-Garcia, D., et al.[2023]

Peripheral nerve stimulation (PNS) is a safe and effective treatment for chronic pain, showing significant reductions in patient-reported pain scores from an average of around 7.4 to approximately 1.6 within the first month and sustained relief for up to 24 months across 57 patients.

Patients also experienced a notable decrease in their use of morphine, indicating that PNS not only alleviates pain but may also reduce reliance on opioid medications, with significant reductions observed at 6, 12, and 24 months post-procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Peripheral Nerve Stimulation with a High Frequency Electromagnetic Coupled (HF-EMC) Powered Implanted Receiver in Treating Different Pain Targets/Neuralgias. Abd-Elsayed, A., Moghim, R.[2023]

A study involving 33 patients with chronic post-surgical knee pain demonstrated that externally powered peripheral nerve stimulation (PNS) targeting the saphenous nerve significantly improved pain levels, quality of life, mood, and sleep quality, with many patients able to reduce their opioid use after treatment.

The landmark-guided implantation technique for PNS was found to be safe and less invasive compared to traditional neuromodulation methods, with a low complication rate, although 18.2% of patients did not experience sufficient benefit and required explantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peripheral nerve stimulation for the treatment of chronic knee pain. Früh, A., Sargut, TA., Hussein, A., et al.[2023]

Peripheral nerve stimulation (PNS) is a less invasive and potentially more cost-effective alternative to spinal cord stimulation (SCS) for treating neurogenic pain, as it targets specific painful areas directly.

A case report demonstrated significant pain relief from median nerve stimulation after SCS failed, highlighting the effectiveness of PNS, which remains underutilized and not widely accepted for reimbursement despite its safety and efficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Refractory neuropathic pain from a median nerve injury: spinal cord or peripheral nerve stimulation? A case report. Dewandre, Q., Dubuisson, A., Kaschten, B., et al.[2022]

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]

The WINeRS system allows for wireless, fully-implanted neural recording and stimulation in freely-moving rats, providing a significant advancement in studying peripheral nerve interfacing without the limitations of battery-powered devices.

This system demonstrated effective recording and stimulation capabilities in vivo, as evidenced by the successful recording of evoked compound action potentials from the sciatic nerve, making it suitable for long-term closed-loop experiments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Implantable Peripheral Nerve Recording and Stimulation System for Experiments on Freely Moving Animal Subjects. Lee, B., Koripalli, MK., Jia, Y., et al.[2019]

In a retrospective study of five patients with chronic neuropathic pain who received wireless percutaneous nerve stimulation (PNS), all patients experienced over 50% pain relief at three months, highlighting the potential efficacy of this minimally invasive technique.

While some patients were able to reduce their analgesic intake, sustained benefits were not observed after one year, indicating the need for further research to evaluate long-term outcomes and the effectiveness of wireless PNS compared to traditional spinal cord stimulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real world experience with minimally invasive wireless percutaneous neuromodulation in a tertiary care centre. Pushparaj, H., Chawla, R., Bhargava, D., et al.[2023]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03877653

NCT03877653 | Freedom-1 Study for Chronic Knee Pain

To demonstrate the potential benefits and risk of active sub-threshold stimulation in the treatment of chronic knee pain as compared to subjects that did ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9969801/

Efficacy of Peripheral Nerve Stimulation with a High ...

PNS has been shown to be safe and effective in treating chronic pain at different sites with sustained pain relief for up to 24 months.

3.

orthopedicreviews.openmedicalpublishing.org

orthopedicreviews.openmedicalpublishing.org/article/143096-60-day-peripheral-nerve-stimulation-in-chronic-knee-pain-a-retrospective-analysis

60-Day Peripheral Nerve Stimulation in Chronic Knee Pain

Eighteen patients were identified who underwent PNS-therapy, and 94.4% (17/18) of the patients achieved ≥ 50% pain relief (responders) following ...

4.

curonix.com

curonix.com/providers/peripheral-nerve-stimulation/

Peripheral Nerve Stimulation

Patients reported more than a 70% improvement in pain at all follow-ups. ... Foot and Ankle patients experienced a 65% reduction in pain scores at 12 months post- ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10771261/

Peripheral Nerve Stimulation in Chronic Knee Pain

The mean perceived percentage reduction in chronic pain was 45.3% (SD=33.3) (N=15) at two weeks, 54% (SD=27.6) (N=12) at two months, and 52% (SD ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02403518

Clinical Outcomes of the Freedom Spinal Cord Stimulation ...

This study evaluates the Freedom SCS (spinal cord stimulation) System for the treatment of chronic back and leg pain.

7.

withpower.com

withpower.com/trial/phase-3-2021-cc44f

Wireless Neuromodulation for Chronic Knee Pain

Wireless neuromodulation, also known as peripheral nerve stimulation (PNS), is considered safe and less invasive than surgery for treating chronic pain. It has ...