The Efficacy of Transcutaneous Pulsed Radiofrequency Acupuncture for Knee Osteoarthritis

Shin Kong Wu Ho-Su Memorial Hospital

Status: Enrolling

Conditions: Osteoarthritis (OA) of the Knee

Treatments: Device: transcutaneous pulsed radiofrequency acupuncture; Device: Sham Comparison

Study type: Interventional

Funder types: Other

Identifiers

NCT06702046

20240723R

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 45 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age from 45 to 85 year-old with knee pain for more than six months
• Fulfill the combined clinical and radiographic criteria of knee OA established by the American College of Rheumatology with a Kellgren and Lawrence score of 2 or greater
• Pain score above 3 (range 0-10 on the visual analog scale; higher scores indicate greater pain
• Could participate in 4 weeks of treatment and 3 months of follow-up

Exclusion criteria

• Knee OA combined with any infection, inflammation, autoimmune disease, or fracture
• History or underlying disease that would affect posture and balance, such as malignancy, dizziness, vertigo, or stroke
• Ever underwent any type of knee operation or internal fixation
• Pregnant or planning to become pregnant
• Receiving other treatment for knee OA in previous 3 months
• History of epilepsy, electronic devices implanted in the body
• Active infection at the stimulator contact site
• Lack of informed consent
• Any other reason thought likely to result in inability to complete the trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups

TCPRF acupuncture group

Experimental group

Description:

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. treatment 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.

Treatment:

Device: transcutaneous pulsed radiofrequency acupuncture

Sham group

Sham Comparator group

Description:

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.

Treatment:

Device: Sham Comparison