NCT06702046

The Efficacy of Transcutaneous Pulsed Radiofrequency Acupuncture for Knee Osteoarthritis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Shin Kong Wu Ho-Su Memorial Hospital · Academic / Other
• Sex: All
• Age: 45 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Efficacy of transcutaneous acupoint pulsed radiofrequency with rehabilitation for knee osteoarthritis.

Detailed description

With the aging population, knee osteoarthritis (KOA) has become a major issue affecting functional living and causing socioeconomic burdens. Its etiology includes biomechanical abnormalities, genetics, hormones, and environmental factors. KOA causes pain, stiffness, and muscle weakness, affecting daily activities and quality of life. Previous studies have shown that traditional acupuncture or electroacupuncture can improve pain and function in knee osteoarthritis. In recent years, pulsed radiofrequency therapy has gradually been applied for pain control in KOA. However, both treatments are invasive, and patients may fear and avoid needle insertion, which also has a higher risk of complications. This study aims to combine the strengths of both treatments by using transcutaneous pulsed radiofrequency(TCPRF) at acupuncture points. This non-invasive treatment approach aims to achieve effective pain control, allowing patients to participate more actively in rehabilitation therapy.

Conditions

• Osteoarthritis (OA) of the Knee

Interventions

Type	Name	Description
DEVICE	transcutaneous pulsed radiofrequency acupuncture	For the TCPRF acupuncture group, the investigators choose ST34 (Liangqiu), SP10 (Xuehai), GB34 (Yanglingquan), SP9 (Yinlingquan) around the affected knee. The TCPRF device is a wearable modality with innovative pulse radiofrequency technology aimed at alleviating symptomatic chronic pain, which revealed that UHF (500-kHz sine wave, 2-Hz frequency with a 25-ms pulse). It was attached to the electrode pad through magnetic attraction. A 500-KHz stimulus was delivered. The symmetric two-phase sine wave has a 2-Hz frequency witha 25-ms pulse width. The treatment has 15 min per time. Electrical stimulation is administered for 30 minutes each session, divided into two 15-minute phases. After the first 15 minutes, the treatment is paused and then restarted for an additional 15 minutes. The output peak current was 13.2 mA and the output peak voltage was 6.6 V at 500 Ω.
DEVICE	Sham Comparison	same protocol will be done on the same acupoints, but the machine will be turn off interiorly. Therefore, although the machine still has lights and a vibrating sensation, it will not release PRF waves.

Timeline

• Start date: 2025-02-24
• Primary completion: 2026-03-31
• Completion: 2026-03-31
• First posted: 2024-11-22
• Last updated: 2025-02-28

Locations

1 site across 1 country: Taiwan