All > Knee Pain

Wireless neuromodulation for Osteoarthritis Knee Pain

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Kettering Adventist Healthcare dba Kettering Health, Kettering, OHOsteoarthritis Knee PainWireless neuromodulation - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 10 Secondary · Reporting Duration: 1 month

1 month
Global Perceived Effect scales (GPES)
McGill Short Form (SF-MPQ-2)
Medication: Change in concomitant pain medication usage
Knee
Range of Motion
Responder rate
Timed Up & Go (TUG)
Treadmill
Visual analog scale (VAS)
Western Ontario and McMasters University Arthritis Score (WOMAC)
Work status (if working);
baseline
Neuropathic pain questionnaire (DN4)

Trial Safety

Safety Progress

1 of 3

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1
Sustained Acoustic Device with 2.5% Diclofenac Patch
1
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2
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Trial Design

2 Treatment Groups

Interventional
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

100 Total Participants · 2 Treatment Groups

Primary Treatment: Wireless neuromodulation · Has Placebo Group · N/A

Interventional
Device
Experimental Group · 1 Intervention: Wireless neuromodulation · Intervention Types: Device
Placebo
Device
PlaceboComparator Group · 1 Intervention: Wireless neuromodulation · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 month

Who is running the clinical trial?

Stimwave TechnologiesLead Sponsor
6 Previous Clinical Trials
347 Total Patients Enrolled
Texas Institute for Pain and spineUNKNOWN
Western Clinical ResearchUNKNOWN
Comprehensive and Interventional Pain Management LLPUNKNOWN
Orthopedic Associates of Southwest OhioUNKNOWN
Performance Pain and Sports Medicine PLLCUNKNOWN
Holy Cross Hospital, IncUNKNOWN
Colorado pain Care, LLCUNKNOWN
Global Scientific Innovations, LLCUNKNOWN
Allied Pain and Spine InstituteUNKNOWN
Main Line SpineUNKNOWN
Steward St. Elizabeth's Medical Center of Boston, Inc.OTHER
24 Previous Clinical Trials
6,211 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been experiencing knee pain due to osteoarthritis for at least three months, and it limits your daily activities.
You have tried two or more non-surgical treatments such as physical therapy, steroid injections, or pain medication and they have not worked to relieve your symptoms.

Who else is applying?

What state do they live in?
Texas66.7%
New York33.3%
How old are they?
18 - 65100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria50.0%
Met criteria50.0%
What site did they apply to?
Texas Institute of Pain and Spine100.0%
How many prior treatments have patients received?
1100.0%
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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