RecruitingNot ApplicableNCT06702046

The Efficacy of Transcutaneous Pulsed Radiofrequency Acupuncture for Knee Osteoarthritis


Sponsor

Shin Kong Wu Ho-Su Memorial Hospital

Enrollment

90 participants

Start Date

Feb 24, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 45 YearsMax Age: 85 Years

Inclusion Criteria4

  • 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 Criteria9

  • 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

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Interventions

DEVICEtranscutaneous 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.

DEVICESham 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.


Locations(1)

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, State, Taiwan

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NCT06702046


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