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Recruiting NCT06702046

The Efficacy of Transcutaneous Pulsed Radiofrequency Acupuncture for Knee Osteoarthritis

No phase Interventional Osteoarthritis (OA) of the Knee

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: transcutaneous pulsed radiofrequency acupuncture, Sham Comparison.
Who it may be relevant to
Registry conditions: Osteoarthritis (OA) of the Knee. Basic parameters: 45 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • 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 w
  • 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.

Primary outcome measures

  • Western Ontario and McMaster Universities Osteoarthritis Index [Time frame: From enrollment to the end of treatment at 4 weeks]
Secondary outcome measures (6)
  • Western Ontario and McMaster Universities Osteoarthritis Index [Time frame: 12 weeks after completing treatment]
  • visual analogue scale [Time frame: From enrollment to the end of treatment at 4 weeks and 12 weeks after completing treatment]
  • Tampa Scale for Kinesiophobia [Time frame: From enrollment to the end of treatment at 4 weeks and 12 weeks after completing treatment]
  • World Health Organization Quality of Life-Brief Version [Time frame: From enrollment to the end of treatment at 4 weeks and 12 weeks after completing treatment]
  • Biodex Stability System [Time frame: From enrollment to the end of treatment at 4 weeks and 12 weeks after completing treatment]
  • Timed Up and Go [Time frame: From enrollment to the end of treatment at 4 weeks and 12 weeks after completing treatment]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • Shin Kong Wu Ho-Su Memorial Hospital — Taipei

Identifiers

NCT: NCT06702046 · 20240723R

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗