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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how electrical stimulation might benefit individuals with knee osteoarthritis (KOA) by enhancing muscle strength, reducing pain, and improving walking ability. Participants will use a medical device at home for 12 weeks; some will receive electrical stimulation during activities, while others will not. The trial aims to determine if stimulation leads to better outcomes compared to no stimulation. Individuals with long-standing knee osteoarthritis who can walk for 30 minutes at a time may be suitable candidates. As an unphased trial, this study allows participants to contribute to innovative research that could enhance KOA treatment options.

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 prior data suggests that this device is safe for individuals with knee osteoarthritis?

Research shows that neuromuscular electrical stimulation (NMES) is safe and effective for individuals with knee osteoarthritis. Studies have found that it reduces knee pain and improves knee function. It is also safe to use immediately after surgery, as it adjusts to the patient's muscle strength.

When combined with functional electrical stimulation (FES), research suggests this mix benefits those at risk of developing knee osteoarthritis. This combination has safely improved muscle strength and physical performance.

Safety reports from studies indicate that side effects are rare. Both NMES alone and in combination with FES are generally well-tolerated, making them promising options for managing knee osteoarthritis symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they use electrical stimulation in a novel way to help manage osteoarthritis. Unlike standard care options like pain relievers and physical therapy, these treatments utilize Functional Electrical Stimulation (FES) and Neuromuscular Electrical Stimulation (NMES) through a wearable device. The Cionic Neural Sleeve NS-100 offers targeted muscle stimulation, potentially improving muscle strength and joint stability during exercise and walking. This innovative approach could enhance mobility and reduce discomfort more effectively, offering a hopeful alternative for those with osteoarthritis.

What evidence suggests that this trial's treatments could be effective for knee osteoarthritis?

Research has shown that electrical stimulation on muscles can strengthen them in people with knee osteoarthritis. In this trial, participants may receive NMES, which involves electrical stimulation during exercise sessions, or a combination of NMES and FES, providing stimulation during both exercise and walking sessions. Some studies suggest that electrical stimulation can reduce pain and improve movement, but it doesn't always outperform exercise alone. Combining it with another type of electrical stimulation has shown promise in easing pain and improving flexibility, though results vary. Overall, these methods can strengthen muscles and improve symptoms, but effects differ among individuals. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37926438/

Effectiveness of neuromuscular electrical stimulation ... Conclusion: This review found insufficient evidence for the effectiveness of NMES combined with exercise in treating knee OA considering PROMs.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6829000/

Utilization and outcomes of neuromuscular electric ... Across all patients, NMES therapy was utilized for an average of 3.5 months (range, 2 weeks to 10 months). On average, 90 sessions (range, 6 to 487) of therapy ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003496724047630

THU0428 THE EFFECTS OF NEUROMUSCULAR ... NMES increased muscle strength in patients with OA compared to the active control group. However, the evidence to date did not demonstrate effects for pain ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02061410

Effects of Neuromuscular Electrical Stimulation (NMES) in ... The hypothesis is that NAMES is able to strengthen the quadriceps muscle and to improve healthy status of elderly with knee osteoarthritis. Official Title.

5. rheumatologyadvisor.com rheumatologyadvisor.com/news/neuromuscular-electrical-stimulation-therapy-improves-knee-osteoarthritis-symptoms/

Neuromuscular Electrical Stimulation Therapy Improves ... Treatment with NMES showed a clinically meaningful reduction in pain, stiffness, and function among patients with knee OA.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6719317/

A Randomized Controlled Trial - PMC - PubMed Central Moreover, NMES is effective for quadriceps strength, knee pain, and physical function for people with knee OA [16]. Unlike volitional contraction (VC), NMES can ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2352344122000760

A Novel Mobile App-Based Neuromuscular Electrical ... This study sought to evaluate the efficacy and safety of a home-based NMES therapy for reduction of pain, stiffness, and function associated with knee OA.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8243113/

Adherence to Neuromuscular Electrical Stimulation ... NMES improved voluntary activation in patients with knee osteoarthritis but did not enhance its effect on muscle strength or function. 90%, 79%, 83%, 76%.

9. jospt.org jospt.org/doi/10.2519/jospt.2023.12028

Who's Afraid of Electrical Stimulation? Let's Revisit the ... NMES is safe to begin immediately post-operatively as it is dosed based on the patient's available isometric MVIC and therefore does not ...