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Electrical Stimulation

Electrical Stimulation for Osteoarthritis

N/A

Waitlist Available

Research Sponsored by Cionic, Inc.

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 weeks, 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will look at how electrical stimulation through a home-based medical device can help people with knee osteoarthritis (KOA) by improving muscle mass, strength, walking, pain, & perceived function.

Who is the study for?

Adults aged 22-75 with knee osteoarthritis who can walk for 30 minutes and tolerate an electrical stimulation device for up to an hour. They should not have had a change in medication or symptom exacerbation recently, no injections into the knees in the past year, and no history of severe arthritis, neurological diseases, or use of similar devices.

What is being tested?

The trial is testing if a home-based program using electrical stimulation over 12 weeks improves muscle strength, pain relief, walking ability, and overall function in adults with knee osteoarthritis compared to those without such stimulation.

What are the potential side effects?

Potential side effects may include discomfort from the device's electrical stimulation leading to skin irritation or muscle fatigue. There might also be temporary increased joint pain after exercise sessions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ daily

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~daily

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

Treatment Details

Study Objectives

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

Primary study objectives

Change in Maximal Voluntary Isometric Contraction of the Quadriceps Using a Dynamometer

Change in Perceived Pain Scores Assessed by the Western Ontario/McMaster Universities Osteoarthritis Index (WOMAC)

Other study objectives

Adherence to the Program

Change in Functional Ability of the Lower Limb

Change in Perceived Functional Capacity

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: NMES and FESExperimental Treatment3 Interventions

Device: Cionic Neural Sleeve NS-100. Participants will wear the device during the 12-week exercise and walking program and receive stimulation assistance during the exercise and walking sessions.

Group II: NMESExperimental Treatment2 Interventions

Device: Cionic Neural Sleeve NS-100. Participants will wear the device during the 12-week exercise and walking program and receive stimulation assistance during the exercise sessions.

Group III: ControlExperimental Treatment1 Intervention

Device: Cionic Neural Sleeve NS-100. Participants will wear the device during the 12-week exercise and walking program. There will be no stimulation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

NMES

2018

Completed Phase 4

~890

FES

2013