KCT0008860尚未招募Unknown
A randomized, outcome assessor-blinded, placebo-controlled, prospective single center pilot clinical trial to evaluate the safety and short-term efficacy of different wavelength(650nm,830nm) of invasive laser medical device (Ellise) on knee osteoarthritis
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- WONTECH
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 50(Year) 至 85(Year)（—）
- 性别
- All
入选标准
- •1) an elderly aged between 50 and 85 years
- •2) diagnosed with KOA according to the American College of Rheumatology diagnostic criteria.
- •3) has knee pain lasting for at least the preceding three months, knee pain that occurred more than 14 days a month, and moderate knee pain ( a mean 100mm VAS score for pain had a range of 35-74 at rest and moving during a week prior to screening)
- •4) patients with stage 2 or stage 3 KOA according to Kellgren-Lawrence(KL) criteria
- •5) voluntary provision of informed consent.
排除标准
- •1) A person who has undergone total knee replacement due to KOA
- •2) posttraumatic KOA patient
- •3) has a serious diseases (cancer, severe kidney disease, severe liver disease, severe cardiovascular disease, severe central nervous system disease, diabetic neuropathy)
- •4) has a knee pain caused by inflammatory disease, tumor, trauma, rheumatoid arthritis, autoimmune disease, severe Genu varum or Genu valgum, severe hip joint disease, or gout
- •5) has a history of treatment for mental illness (dementia, schizophrenia, or epilepsy) or drug/alcohol dependency in the 6 months preceding screening
- •6) has been injected with Intraarticular mucus supplement (hylan, sodium hyaluronate, and hyalulonan) for the purpose of treating KOA in the 6 months preceding screening
- •7) has drained knee joint fluid in the 3 months preceding screening
- •8) has received prolotherapy or steroid injections into the knee joint in the 3 months preceding screening
- •9) current treatment for KOA, such as Korean medicine treatment, physical therapy, medication, or health functional food in the 4 weeks preceding screening
- •10) has other diseases that require treatment for pain control, such as steroids or NSAIDs
- •11) has contraindications for ILA, such as presence of electronic medical devices, severe skin disease in the knee region, blood clotting abnormalities, or presence of metallic devices in the knee
- •12) has a history of knee surgery within one year or scheduled procedures during the trial
- •13) pregnancy, breastfeeding, or having a plan for pregnancy.
- •14) A people who is participating in other trials or has participated in other trials within 8 weeks prior to screening
研究者
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