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Neuromodulation Device

Wireless Neuromodulation for Chronic Knee Pain

N/A

Recruiting

Research Sponsored by Curonix LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject is over 18 years of age;

Subject has been diagnosed with Kellgren-Lawrence Grade II or III knee osteoarthritis, confirmed by X-ray studies conducted in the last year

Must not have

Subjects with multiple complaints involving concomitant knee, foot, or ankle pathology or radiculopathy, that will not be amenable to study due to the overlap of pain complaints

Neurogenic or vascular claudication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month

Summary

This trial is testing if a new treatment for chronic knee pain is effective. The primary endpoint is if the subjects have a 50% decrease in pain after 1 month.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly listed, potential side effects may include discomfort at the implant site, possible skin irritation or infection, and reactions to local anesthetics used during the procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 18 years old.

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My knee osteoarthritis is moderate to severe, confirmed by recent X-rays.

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My knee pain is due to moderate or severe arthritis, confirmed by recent X-rays.

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I am over 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have conditions like lymphedema that could affect my surgery area.

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My knee arthritis is severe, confirmed by recent X-rays.

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I do not have any severe ongoing illnesses like serious liver, kidney problems, or uncontrolled infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Responder rate

Secondary study objectives

Global Perceived Effect scales (GPES)

Koos Jr

Mankoski pain scale

+7 more

Other study objectives

Treadmill

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: InterventionalExperimental Treatment1 Intervention

Single arm, active stimulation

Group II: PlaceboPlacebo Group1 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.

0 / 9Eligibility criteria met