What side effects are associated with this type of intervention?

Common treatments for osteoarthritis, such as NSAIDs, intraarticular injections, and physical therapy, have various side effects. NSAIDs can cause gastrointestinal issues, cardiovascular risks, and renal impairment. Intraarticular injections, including glucocorticoids, may lead to joint infection, post-injection flare, and potential cartilage damage with repeated use. Physical therapy is generally safe but may cause temporary pain or discomfort. Pulsed Radio Frequency (PRF), which is being studied for its analgesic properties, has reported side effects like transient pain, numbness, and superficial burns, though more research is needed to fully understand its safety profile.

What prior FDA approvals exist?

FDA-approved treatments for osteoarthritis primarily include nonsteroidal anti-inflammatory drugs (NSAIDs) like celecoxib, which is a COX-2 selective inhibitor, and duloxetine, an antidepressant used for chronic pain management. Intraarticular glucocorticoid injections are also approved for short-term pain relief in severe cases. While treatments like Platelet-Rich Plasma (PRP) and transcutaneous electrical nerve stimulation (TENS) have been explored, they are generally not recommended due to insufficient evidence of efficacy. There are no specific FDA approvals for treatments exactly like Pulsed Radio Frequency (PRF) for osteoarthritis, which is still under investigation for its potential analgesic properties and mechanisms beyond direct nerve stimulation.

What other types of research exist?

Promising, novel alternatives to Pulsed Radio Frequency (PRF) for osteoarthritis patients include: 1) Transcutaneous Electrical Nerve Stimulation (TENS), which has shown effectiveness in chronic pain management, including fibromyalgia and low back pain. 2) Spinal Cord Stimulation (SCS), particularly high-frequency and burst waveforms, which have been effective in treating chronic pain conditions. 3) Platelet-Rich Plasma (PRP) therapy, which is being explored for its potential in musculoskeletal injuries and may offer benefits for osteoarthritis. These alternatives provide different mechanisms of action and may offer effective pain relief for osteoarthritis patients.

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Pulsed Radiofrequency vs Physical Therapy for Knee Osteoarthritis

N/A

Waitlist Available

Led By Ronald Takemoto, M.D.

Research Sponsored by VA Long Beach Healthcare System

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Radiologic evidence of Kellgren-Lawrence knee arthritis between levels 1-3

Be older than 18 years old

Must not have

Any patient unwilling to receive physical therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if PRF, a treatment using short bursts of radio waves, can reduce chronic knee pain in adults with osteoarthritis. The study aims to see if PRF provides pain relief by affecting the nerves in the knee. Pulsed radiofrequency (PRF) has been used in various studies to treat knee pain originating from osteoarthritis, showing potential in pain relief and functional improvement.

Who is the study for?

This trial is for adults over 18 with knee osteoarthritis, confirmed by specific radiologic criteria and meeting the American College of Rheumatology's standards. It excludes those who can't undergo knee procedures due to health risks, vulnerable groups as defined by the VA, individuals unable to follow up after treatment, those with metal in their affected knee or alternative diagnoses, and patients with pacemakers.

What is being tested?

The study tests if Pulsed Radiofrequency (PRF) can relieve chronic knee pain from osteoarthritis better than physical therapy. It looks at pain relief immediately after treatment and at one and three months post-treatment. The goal is also to compare PRF's effectiveness against physical therapy directly.

What are the potential side effects?

While not explicitly listed in the provided information, potential side effects of PRF may include temporary discomfort or pain at the site of application, skin irritation or burns. Physical Therapy generally has minimal side effects but may sometimes cause muscle soreness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My knee arthritis is mild to moderate, based on X-ray results.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am not willing to undergo physical therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

VAS pain scores and Western Ontario and McMaster Universities Arthritis Index (WOMAC) with pulsed radiofrequency vs physical therapy

Secondary study objectives

Safety of pulsed radiofrequency for knee pain treatment

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Pulsed RadiofrequencyExperimental Treatment1 Intervention

Pulsed Radiofrequency This group will receive one dose of intra-articular PRF in the affected knee using previous literature standards. This includes standard blood pressure monitoring, sterile preparation, and needle insertion of the PRF probe directed at the site of maximal pain. The RFG-3C Plus radiofrequency generator will be activated at 42C, pulse width 10ms, and 2Hz frequency for 15 min.

Group II: Physical TherapyActive Control1 Intervention

This group will receive standard of care outpatient physical therapy weekly for 3-4 weeks with therapist instructions to reduce knee pain.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for osteoarthritis (OA) include NSAIDs, which reduce inflammation and pain by inhibiting cyclooxygenase enzymes, and physical therapy, which improves joint function and reduces pain through exercise and manual techniques. Pulsed Radio Frequency (PRF) is another treatment being studied, hypothesized to provide analgesic effects potentially through mechanisms beyond direct nerve stimulation. Platelet-rich plasma (PRP) injections are thought to reduce inflammation and promote tissue healing through growth factors. Understanding these mechanisms helps OA patients and their doctors choose the most suitable treatment based on individual needs and responses.

Systematic Review of Radiofrequency Ablation for Management of Knee Pain.