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

Trial Summary

What is the purpose of this trial?

The purpose of study is to evaluate the efficacy of the electrical muscle stimulation (EMS) device in patients with patellofemoral pain known as anterior knee pain. Usual treatment for it is physical therapy (PT). We want to evaluate and see if adding the electrical muscle stimulation will fasten the recovery and improved outcome in patellofemoral pain syndrome. Half of participants will receive EMS and PT while other half will receive PT only.

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.

What data supports the effectiveness of electrical stimulation for knee pain?

Research shows that electrical stimulation, like TENS, can help reduce knee pain and improve function in people with osteoarthritis. It has been found to be as effective as exercise in improving pain, physical function, and muscle strength, making it a useful option for those who cannot perform regular exercise. ^{1 2 3 4 5}

Is electrical stimulation safe for treating knee pain?

The research suggests that electrical stimulation, including methods like TENS and NMES, is generally used in clinical practice for conditions like knee osteoarthritis. While the studies focus more on effectiveness, they imply that these treatments are considered safe enough to be used by physical therapists and in clinical trials. ^{1 4 5 6 7}

How does physical therapy differ from other treatments for knee pain?

Physical therapy (PT) for knee pain focuses on exercises and movements to improve strength, flexibility, and function, which is different from treatments like electrical stimulation that primarily aim to reduce pain. PT is a hands-on approach that can be tailored to individual needs, making it unique in its ability to address the underlying causes of knee pain and improve overall mobility. ^{2 4 5 8 9}

Research Team

Leon Popovitz, MD

Principal Investigator

Northwell Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

References

1. Canada 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. [2019]

2. Germany pubmed.ncbi.nlm.nih.gov

Use of Transcutaneous Electrical Nerve Stimulation Device in Early Osteoarthritis of the Knee. [2015]

3. Germany pubmed.ncbi.nlm.nih.gov

Effects of quadriceps electrical stimulation program on clinical parameters in the patients with knee osteoarthritis. [2022]

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

Does transcutaneous electrical nerve stimulation improve the physical performance of people with knee osteoarthritis? [2006]

5. Pakistan pubmed.ncbi.nlm.nih.gov

Comparing the effects of manual therapy versus electrophysical agents in the management of knee osteoarthritis. [2014]

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

Electrical stimulation for pain relief in knee osteoarthritis: systematic review and network meta-analysis. [2018]

7. Canada pubmed.ncbi.nlm.nih.gov

Neuromuscular Electrical Stimulation for Treatment of Muscle Impairment: Critical Review and Recommendations for Clinical Practice. [2019]

8. England 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. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Use of transcutaneous electrical nerve stimulation along with functional tasks for immediate pain relief in individuals with knee osteoarthritis. [2022]