The Efficacy of Transcutaneous Pulsed Radiofrequency Acupuncture for Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Western Ontario and McMaster Universities Osteoarthritis Index
研究概览
简要总结
Efficacy of transcutaneous acupoint pulsed radiofrequency with rehabilitation for knee osteoarthritis.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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. 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.
干预措施: transcutaneous pulsed radiofrequency acupuncture (Device)
Sham group
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.
干预措施: Sham Comparison (Device)
结局指标
主要结局
Western Ontario and McMaster Universities Osteoarthritis Index
时间窗: From enrollment to the end of treatment at 4 weeks
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.
次要结局
- Western Ontario and McMaster Universities Osteoarthritis Index(12 weeks after completing treatment)
- visual analogue scale(From enrollment to the end of treatment at 4 weeks and 12 weeks after completing treatment)
- Tampa Scale for Kinesiophobia(From enrollment to the end of treatment at 4 weeks and 12 weeks after completing treatment)
- World Health Organization Quality of Life-Brief Version(From enrollment to the end of treatment at 4 weeks and 12 weeks after completing treatment)
- Biodex Stability System(From enrollment to the end of treatment at 4 weeks and 12 weeks after completing treatment)
- Timed Up and Go(From enrollment to the end of treatment at 4 weeks and 12 weeks after completing treatment)