Electrical Stimulation for Osteoarthritis

Overseen By Rebecca Webster, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cionic, Inc.

Disqualifiers: Neurological disease, Seizures, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

6 Participants Needed

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, you should not have had any recent changes in medication or worsening of symptoms in the last 60 days.

What data supports the effectiveness of this treatment for osteoarthritis?

Research shows that combining neuromuscular electrical stimulation (NMES) with exercise can improve pain and function in people with knee osteoarthritis. NMES has also been effective in strengthening muscles and improving movement in other conditions, suggesting it could be beneficial for osteoarthritis as well. ^{1 2 3 4 5}

How is the treatment of electrical stimulation for osteoarthritis different from other treatments?

Electrical stimulation treatments like NMES (neuromuscular electrical stimulation) and FES (functional electrical stimulation) are unique because they use electrical impulses to cause muscles to contract involuntarily, which can help strengthen muscles and improve joint function. This approach is different from traditional treatments that may rely on medication or physical therapy alone, and it can be used as an alternative or in combination with exercises to enhance their effectiveness. ^{2 6 7 8 9}

What is the purpose of this trial?

The purpose of this research is to investigate if a 12-week program of stimulation assisted activities can combat disuse atrophy for individuals diagnosed with knee osteoarthritis (KOA). This study will use a home-based medical device to administer electrical stimulation and measure its effect on outcomes that include quadriceps strength, perceived functional capacity, pain, and walking performance. It was hypothesized that stimulation assisted activities will show larger muscle mass and strength improvements; improved gait kinematics, pain and perceived function; and a high compliance to the assigned program compared to no stimulation.

Eligibility Criteria

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.

Inclusion Criteria

I am between 22 and 75 years old with knee osteoarthritis.

I can use the device for up to an hour during lab sessions.

I haven't had knee injections with hyaluronic acid or cortisone in the last year.

Exclusion Criteria

I cannot walk even with my leg brace on.

I cannot feel my leg that is most affected.

I have a condition like peripheral neuropathy that affects my muscle response.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 12-week home-based electrical stimulation program using the Cionic Neural Sleeve, with different groups receiving varying levels of stimulation during exercises and walking.

12 weeks

Baseline, 6 weeks, 12 weeks

Follow-up

Participants are monitored for changes in quadriceps strength, perceived pain, functional capacity, and walking performance.

4 weeks

Treatment Details

Interventions

• 12-week exercise and walking program
• FES
• NMES

Trial Overview 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.

Participant Groups

Group I: NMES and FES Experimental Treatment 3 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: NMES Experimental Treatment 2 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: Control Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Cionic, Inc.

Lead Sponsor

Trials

5

Recruited

130+

Findings from Research

Functional neuromuscular electrical stimulation (FES) can effectively produce muscle contractions that aid in joint stability and limb movement, which is crucial for patient recovery after illness or injury.

FES not only helps improve patient function during recovery but also has the potential to transition into neural prosthetic systems for individuals who do not fully regain movement, highlighting its importance in rehabilitation and community healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic FES: from rehabilitation to neural prosthetics. Campbell, JM., Meadows, PM.[2005]

References

1. United States pubmed.ncbi.nlm.nih.gov

A clinical trial of neuromuscular electrical stimulation in improving quadriceps muscle strength and activation among women with mild and moderate osteoarthritis. [2016]

2. United States pubmed.ncbi.nlm.nih.gov

Effects of neuromuscular electrical stimulation combined with exercises versus an exercise program on the pain and the function in patients with knee osteoarthritis: a randomized controlled trial. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Therapeutic FES: from rehabilitation to neural prosthetics. [2005]

4. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of neuromuscular electrical stimulation training combined with exercise on patient-reported outcomes measures in people with knee osteoarthritis: A systematic review and meta-analysis. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of interphase interval and stimulation form on dorsiflexors contraction force. [2015]

6. England pubmed.ncbi.nlm.nih.gov

Lab-based feasibility and acceptability of neuromuscular electrical stimulation in hip osteoarthritis rehabilitation. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

A Novel Mobile App-based Neuromuscular Electrical Stimulation Therapy for the Management of Knee Osteoarthritis: Results From an Extension Study of a Randomized, Double-blind, Sham-controlled, Multicenter Trial. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Does neuromuscular electrical stimulation enhance the effectiveness of an exercise programme in subjects with knee osteoarthritis? A randomized controlled trial. [2013]

9. United States pubmed.ncbi.nlm.nih.gov

The effectiveness of pulsed electrical stimulation in the management of osteoarthritis of the knee: results of a double-blind, randomized, placebo-controlled, repeated-measures trial. [2011]