Efficacy of transcutaneous acupoint pulsed radiofrequency with rehabilitation for knee osteoarthritis.
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
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
Parallel
transcutaneous pulsed radiofrequency acupuncture
DeviceFor 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.
Sham Comparison
Devicesame 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.
Western Ontario and McMaster Universities Osteoarthritis Index
WOMAC is used to assess pain(5 items), stiffness(2 items), and physical function(17 items) of knee OA with excellent validity and reliability. Higher scores mean worse symptoms with more functional limitation.
Western Ontario and McMaster Universities Osteoarthritis Index
WOMAC is used to assess pain(5 items), stiffness(2 items), and physical function(17 items) of knee OA with excellent validity and reliability. Higher scores mean worse symptoms with more functional limitation
visual analogue scale
Visual analogue scale (VAS) at rest and during activity will be recorded. VAS of pain is obtained using a 10-cm long horizontal line, with 0 cm on the left, indicating no pain, and 10 cm on the right, indicating the most severe pain.
Tampa Scale for Kinesiophobia
Tampa Scale for Kinesiophobia (TSK-11) is used to evaluate the pain-related fear. It consists of 11 items, each rated on a 4-point Likert scale ranging from "strongly disagree" to "strongly agree." Higher scores indicate greater fear of movement, which can be a significant barrier to rehabilitation and physical activity
World Health Organization Quality of Life-Brief Version
World Health Organization Quality of Life-Brief Vision (WHOQoL-BREF) was used to assess general health-related quality of life. It consists of total 28 items with 4 domains: physical, psychological, social relationship, and environmental (internal consistency: 0.7-0.77, reliability: 0.76-0.8, with good validity). The scores range from 0 to 100, the higher the score, the better the quality of life
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