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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am over 18 years old.
Select...
My knee osteoarthritis is moderate to severe, confirmed by recent X-rays.
Select...
My knee pain is due to moderate or severe arthritis, confirmed by recent X-rays.
Select...
I am over 18 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Responder rate
Secondary outcome measures
Global Perceived Effect scales (GPES)
Koos Jr
Mankoski pain scale
+7 moreOther outcome measures
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.
Find a Location
Who is running the clinical trial?
Advanced Spine and PainUNKNOWN
Florida Joint Pain InstituteUNKNOWN
Curonix LLCLead Sponsor
6 Previous Clinical Trials
342 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am over 18 years old.My hip or foot hurts more than my knee.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.I have pain in my knee, foot, or ankle that might interfere with the study.My knee osteoarthritis is moderate to severe, confirmed by recent X-rays.I experience leg pain from walking due to nerve or blood vessel issues.I have severe pain in my other knee that affects how active I can be.I haven't had knee surgery in the last 3 months.I was told I can't have the procedure due to my body's structure.I do not have severe conditions like rheumatoid arthritis that could affect pain and function assessments.I have conditions like lymphedema that could affect my surgery area.I've tried at least two treatments like physical therapy or painkillers without success.My knee pain is due to moderate or severe arthritis, confirmed by recent X-rays.My knee arthritis is severe, confirmed by recent X-rays.I have been approved for the procedure after experiencing chronic knee pain post knee replacement.I've tried at least two treatments like physical therapy or painkillers without success.I understand the study, can follow its procedures, and can attend all required follow-ups.I have had chronic knee pain from arthritis for over three months.I am over 18 years old.I do not have any severe ongoing illnesses like serious liver, kidney problems, or uncontrolled infections.I have had severe knee pain from arthritis for over three months.I experienced significant, but short-term relief from a specific knee injection.
Research Study Groups:
This trial has the following groups:- Group 1: Interventional
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Osteoarthritis Patient Testimony for trial: Trial Name: NCT03877653 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any openings remaining in this research project?
"Indeed, this research endeavour is currently recruiting volunteers. The details of the trial first appeared on September 1st 2021 and have been modified up until August 9th 2022."
Answered by AI
What is the geographical scope of this experiment?
"Patients seeking enrolment in this clinical trial can do so at the Texas Institute of Pain and Spine (located in Pearland, TX), Holy Cross Hospital Inc. (in Fort Lauderdale, FL) or Comprehensive and Interventional Pain management LLP (in Henderson, NV). Additionally, there are 12 other participating sites across the country."
Answered by AI
How many individuals are being accepted into the investigation?
"This clinical trial necessitates 100 patients that meet the pre-determined qualifications. Participating individuals can visit either Texas Institute of Pain and Spine in Pearland, Texas or Holy Cross Hospital, Inc located in Fort Lauderdale, Florida."
Answered by AI
Who else is applying?
What state do they live in?
New York
California
Texas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Main Line Spine
Performance pain and sports medicine
Western Clinical Research
Other
How many prior treatments have patients received?
0
1
2
3+
What questions have other patients asked about this trial?
How long does each visit take and what are the entire set of details regarding this?
PatientReceived 1 prior treatment
Why did patients apply to this trial?
pain and nothing works. I’m interested in the study. I believe it could help.
PatientReceived no prior treatments
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- Performance pain and sports medicine: < 24 hours
Average response time
- < 1 Day
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