Electrical Stimulation vs Physical Therapy for Knee Pain

Overseen By Leon Popovitz, MD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 3

Sponsor: Northwell Health

Must not be taking: Steroids

Disqualifiers: Patellar dislocation, Tendinitis, Pregnancy, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 12 months

92 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether adding an electrical muscle stimulation (EMS) device to regular physical therapy (PT) can speed up recovery and improve outcomes for individuals with patellofemoral pain, a type of knee pain. Participants will be divided into two groups: one will receive both EMS and PT, while the other will receive only PT. The trial seeks individuals who have experienced knee pain for more than three months, particularly if it occurs during activities like sitting with bent knees, going downstairs, or squatting, and who have not had any knee injuries or surgeries. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have taken oral or injected steroid medications in the last 3 months, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that electrical muscle stimulation (EMS) can safely treat knee pain. For instance, one study found that combining EMS with exercise therapy reduced knee pain more quickly, allowing people to feel better faster with less need for light activities. Another study indicated that using electrical stimulation devices significantly reduced pain, although the quality of evidence varies.

Generally, EMS is well-tolerated, with most people not experiencing serious side effects. Different studies offer varying levels of evidence, but overall, EMS is considered safe for many. For those considering joining a clinical trial, this information suggests that EMS usually does not cause harm, especially when used alongside physical therapy. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about exploring the combination of Electrical Muscle Stimulation (EMS) with Physical Therapy (PT) for knee pain because it offers a unique approach compared to standard treatments like medication and traditional physical therapy alone. EMS works by using electrical currents to stimulate muscle contractions, potentially enhancing muscle strength and reducing pain more effectively than PT alone. This combined approach might offer faster pain relief and improved mobility, which are significant advantages over current options that primarily focus on exercises and manual therapies.

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

This trial will compare the effects of Electrical Muscle Stimulation (EMS) combined with Physical Therapy (PT) against PT alone for knee pain. Studies have shown that EMS can reduce knee pain and improve mobility. For example, research suggests that EMS can lower pain and enhance physical performance in people with knee problems. One study found that EMS increased muscle strength in patients with knee osteoarthritis, a joint disease. However, not all studies agree on EMS's effectiveness for pain relief. Overall, adding EMS might offer a promising way to improve recovery and outcomes for those with knee pain. ^{6 7 8 9 10}

Who Is on the Research Team?

Leon Popovitz, MD

Principal Investigator

Northwell Health

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-40 with patellofemoral pain syndrome, which includes knee pain from sitting, stairs, or exercise. Candidates shouldn't have a history of knee injuries or surgery and can't be pregnant or have used steroids recently.

Inclusion Criteria

No history of injury

I have never had knee surgery.

I experience pain in at least 3 activities: sitting, going downstairs, kneeling/squatting, or during sports.

Exclusion Criteria

My kneecap has slipped out of place before.

I have inflammation in the area around my joint.

Pregnancy (patient reported pregnancy, in case of doubt patient will be referred to their OBG/GYN physician to exclude the pregnancy)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Electrical Muscle Stimulation (EMS) and Physical Therapy (PT) or PT only

12 months

Visits at pre-treatment, 3 weeks, 6 weeks, 12 weeks, 6 months, and 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• EMS
• Physical therapy

Trial Overview The study compares the effectiveness of electrical muscle stimulation (EMS) combined with physical therapy (PT) versus PT alone in improving knee pain outcomes in patients with anterior knee pain.

How Is the Trial Designed?

Group I: EMS and PT Experimental Treatment 2 Interventions

Group 1: Electrical Muscle stimulation (EMS) and Physical therapy (PT).

Group II: Only PT Active Control 1 Intervention

Group 2: Only Physical therapy (PT).

Physical therapy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Physical Therapy for:

• Patellofemoral Pain Syndrome
• Musculoskeletal Disorders
• Rehabilitation

Approved in European Union as Physiotherapy for:

• Patellofemoral Pain Syndrome
• Musculoskeletal Disorders
• Rehabilitation

Approved in Canada as Physical Therapy for:

• Patellofemoral Pain Syndrome
• Musculoskeletal Disorders
• Rehabilitation

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Recruited

470,000+

Published Research Related to This Trial

A survey of 413 physical therapists in Florida revealed that the majority consider therapeutic exercise (94%) and education (93%) effective for treating knee osteoarthritis, aligning with clinical guidelines.

Despite the preference for evidence-based interventions, many therapists still use less effective treatments like electrotherapy (28% effectiveness) and ultrasound (19% effectiveness), indicating a gap in adherence to scientific evidence in practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How Do Physical Therapists Treat People with Knee Osteoarthritis, and What Drives Their Clinical Decisions? A Population-Based Cross-Sectional Survey. da Costa, BR., Vieira, ER., Gadotti, IC., et al.[2019]

In a study of 23 patients with early-stage osteoarthritis of the knee, the use of transcutaneous electrical nerve stimulation (TENS) significantly reduced pain and improved functional outcomes, including strength and quality of life, over a 3-month period.

Patients using TENS showed notable improvements in objective measures like the timed-up-and-go test and quadriceps strength compared to those receiving standard care, suggesting TENS could be a beneficial adjunct treatment for knee arthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Transcutaneous Electrical Nerve Stimulation Device in Early Osteoarthritis of the Knee. Cherian, JJ., Kapadia, BH., Bhave, A., et al.[2015]

In a study involving 20 volunteers with mild-to-moderate knee osteoarthritis, active transcutaneous electrical nerve stimulation (TENS) significantly reduced knee pain during functional tests compared to inactive TENS.

The pain relief from active TENS was particularly notable in participants without anxiety or depression, suggesting that TENS can be an effective conservative treatment for managing knee OA pain during physical activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of transcutaneous electrical nerve stimulation along with functional tasks for immediate pain relief in individuals with knee osteoarthritis. Lawson, D., Degani, AM., Lee, K., et al.[2022]

In a study involving 50 women with knee osteoarthritis, both electrical stimulation and biofeedback-assisted isometric exercises significantly improved pain, physical function, and muscle strength over 4 weeks of treatment.

Electrical stimulation was found to be as effective as traditional exercise therapy, making it a suitable alternative for patients who struggle with or cannot participate in exercise programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of quadriceps electrical stimulation program on clinical parameters in the patients with knee osteoarthritis. Durmuş, D., Alayli, G., Cantürk, F.[2022]

In a study of 50 patients with knee osteoarthritis, manual therapy using Maitland joint mobilization showed significantly better clinical outcomes compared to electrophysical agents like TENS and cold packs, with a p-value of 0.000 versus 0.008 for the respective groups.

The manual therapy group experienced a mean improvement of 22.36 in the WOMAC index, indicating greater reductions in pain and stiffness, compared to a mean improvement of 9.72 in the electrophysical agents group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing the effects of manual therapy versus electrophysical agents in the management of knee osteoarthritis. Ali, SS., Ahmed, SI., Khan, M., et al.[2014]

In a study involving 70 male athletes recovering from ACL reconstruction, adding transcutaneous electrical nerve stimulation (TENS) to a rehabilitation exercise program did not provide any additional benefits in pain relief or knee function compared to exercise alone.

Both groups showed improvements in pain and knee function over time, but the results indicate that TENS is not an effective enhancement to the rehabilitation process during the first four weeks post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adding high-frequency transcutaneous electrical nerve stimulation to the first phase of post anterior cruciate ligament reconstruction rehabilitation does not improve pain and function in young male athletes more than exercise alone: a randomized single-blind clinical trial. Forogh, B., Aslanpour, H., Fallah, E., et al.[2019]

Transcutaneous electrical nerve stimulation (TENS) significantly improved maximum knee range of motion (ROM) after 10 days compared to a placebo, indicating its efficacy in managing physical symptoms of osteoarthritis (OA).

However, TENS did not lead to significant improvements in functional performance, as measured by the Timed-Up-and-Go Test, suggesting that while it helps with pain and mobility, additional treatments like exercise may be necessary for better functional outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does transcutaneous electrical nerve stimulation improve the physical performance of people with knee osteoarthritis? Law, PP., Cheing, GL., Tsui, AY.[2006]

Interferential current (IFC) therapy was found to be significantly effective in reducing pain intensity in patients with knee osteoarthritis, making it the most promising treatment option among various electrical stimulation therapies evaluated in 27 randomized controlled trials.

While IFC showed the best results for pain relief, the overall evidence was limited due to heterogeneity and small sample sizes in some studies, suggesting that other electrical stimulation therapies may not be effective or their safety is uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical stimulation for pain relief in knee osteoarthritis: systematic review and network meta-analysis. Zeng, C., Li, H., Yang, T., et al.[2018]

A systematic review of literature on neuromuscular electrical stimulation (NMES) identified effective stimulation parameters for treating muscle impairments in conditions like stroke, ACL reconstruction, and knee osteoarthritis, based on a consensus among six Canadian PT experts.

The article serves as a comprehensive resource for physiotherapists, offering evidence-based recommendations and safety tips for the effective application of NMES in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromuscular Electrical Stimulation for Treatment of Muscle Impairment: Critical Review and Recommendations for Clinical Practice. Nussbaum, EL., Houghton, P., Anthony, J., et al.[2019]

Citations

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Effectiveness of whole-body electromyostimulation on knee ... WB-EMS was found to be effective in relieving knee pain symptoms and improving physical function in individuals with symptomatic knee OA compared to usual care ...

2. 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3787573/

Effects of Neuromuscular Electrical Stimulation Combined ... Conclusion. The addition of NMES to exercise did not improve the outcomes assessed in knee OA patients. This study was registered at the Australian Clinical ...

4. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2021.779019/full

Effect of Neuromuscular Electrical Stimulation After Total ... Conclusion: As a supplementary treatment after TKA, postoperative NMES could improve the short-term to long-term quadriceps muscle strength, mid-term pain, and ...

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

A Randomized Controlled Trial - PMC - PubMed Central These results suggest the HTS is effective for alleviating pain and improving physical performance in women with risk factors for knee OA. However, the HTS does ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10616008/

Do Electrical Stimulation Devices Reduce Pain and ... Ten of 13 reviewed forms of ES have only limited quality evidence for clinically significant reduction of pain or improvement of function across different ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0003999324012267

Usefulness and Safety of a Wearable Transcutaneous ... The group using TENS showed improved effects of early reduction in knee pain and when combined with exercise therapy, a reduction in time spent in light- ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5683854/

Neuromuscular Electrical Stimulation for Treatment of Muscle ... This article provides physiotherapists with a resource to enable evidence-informed, effective use of NMES for PT practice.

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

Who's Afraid of Electrical Stimulation? Let's Revisit the ... Again, the muscle contraction elicited by the electrical stimulation should produce a force of at least 50% of the MVIC, and more is better. The ...

10. aetna.com aetna.com/cpb/medical/data/1_99/0011.html

Electrical Stimulation for Pain - Medical Clinical Policy ... Trial of percutaneous stimulation was successful (resulting in at least a 50 % reduction in pain for a minimum of 3 days). Note: If a peripheral nerve ...