NMES and FES for Osteoarthritis

Phase-Based Progress Estimates
Cionic, Inc., San Francisco, CAOsteoarthritis+1 MoreFES - Device
22 - 75
All Sexes
What conditions do you have?

Study 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.

Eligible Conditions
  • Osteoarthritis
  • Osteoarthritis of the Knee

Treatment Effectiveness

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: Baseline, 6 weeks, 12 weeks

Week 12
Change in Functional Ability of the Lower Limb
Change in Maximal Voluntary Isometric Contraction of the Quadriceps Using a Dynamometer
Change in Perceived Functional Capacity
Change in Perceived Pain Scores Assessed by the Western Ontario/McMaster Universities Osteoarthritis Index (WOMAC)
Change in Perceived Quality of Life
Change in Thigh Muscle Volume
Change in Walking Performance
Adherence to the Program

Trial Safety

Trial Design

2 Treatment Groups

1 of 2
1 of 2

Experimental Treatment

45 Total Participants · 2 Treatment Groups

Primary Treatment: NMES and FES · No Placebo Group · N/A

NMES and FESExperimental Group · 3 Interventions: FES, NMES, 12-week exercise and walking program · Intervention Types: Device, Device, Other
NMESExperimental Group · 2 Interventions: NMES, 12-week exercise and walking program · Intervention Types: Device, Other
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 4

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 6 weeks, 12 weeks

Who is running the clinical trial?

Cionic, Inc.Lead Sponsor
2 Previous Clinical Trials
82 Total Patients Enrolled

Eligibility Criteria

Age 22 - 75 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are able to ambulate for 30 minutes per session, three times a week (with or without an aid).
You have not experienced any changes in medication or an increase of symptoms within the past two months.
You have radiographic evidence of knee osteoarthritis, graded 2 or 3 on the Kellgren and Lawrence scale, or a physician diagnosis of mild to moderate KOA if imaging is not available.
You have not had any hyaluronic acid or cortisone injections into your knees in the last year.
You are between the ages of 22 and 75 with a diagnosis of knee osteoarthritis.
You can endure the device for 60 minutes or less each laboratory session.

Frequently Asked Questions

Does the upper age limit for this study extend beyond 60 years of age?

"This clinical trial has designated a participant age range of 22 to 75. In contrast, there are 37 studies open to minors and 642 trials that accept seniors over the age of 65." - Anonymous Online Contributor

Unverified Answer

Is registration now open for the experiment?

"Affirmative. According to clinicaltrials.gov, this medical investigation is currently accepting patients and began recruitment on March 1st 2023. Updating of the trial latest occurred on 3/10/2023 with 45 participants needed from a single location." - Anonymous Online Contributor

Unverified Answer

What is the cap on how many participants may join this clinical analysis?

"Affirmative. Evidenced on clinicaltrials.gov, this medical research is presently seeking volunteers to join the experiment which commenced March 1st 2023 and was most recently edited ten days later. 45 participants must be enrolled from one location." - Anonymous Online Contributor

Unverified Answer

Is participation in this medical research open to the public?

"Patients with knee osteoarthritis aged 22-75 are eligible to participate in this clinical trial, of which 45 positions need to be filled." - 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.