KCT0009066招募中Unknown
A Randomized, Double-blind (Subject & Evaluator), Sham Device-controlled, Parallel Design, Prospective Investigator's Clinical Trial to Evaluate Efficacy and Safety of Biodegradable Microneedle Acupuncture on Knee Osteoarthritis
aju Dongshin University Korean Medicine Hospital0 个研究点目标入组 40 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 40
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 o Limit（—）
- 性别
- All
入选标准
- •1) Male or female aged 50 years or older at the time of screening.
- •2) Those who meet the clinical criteria for primary knee osteoarthritis according to the American College of Rheumatology criteria at the time of screening:
- •a) Those who currently have pain in one or both knees
- •b) Those who meet at least three of the following six criteria:
- •- 50 years of age or older.
- •- Morning stiffness in the knee joint lasting less than 30 minutes.
- •- Crepitus in the knee joint.
- •- Bony tenderness.
- •- Bony enlargement of the knee joint.
- •- No palpable warmth.
- •3) The degree of joint space stenosis graded 1-3 according to the Kellgren & Lawrence scale on radiography (X-ray).
- •4) In a 100 mm pain visual analog scale (VAS) during activity, those who marked in the range of 40-80 mm in at least one knee joint.
- •5) Those who had no problem reading and writing in Korean, who have voluntarily submitted written consent, and who signed the consent.
排除标准
- •1) Those with history of knee injury within six months of the screening.
- •2) Those with history of knee surgery with loss of connective tissue around the knee within six months of the screening.
- •3) Those who received intraarticular viscosupplementation Injections, including hylan, sodium hyaluronate, hyalulonan, within six months of the screening.
- •4) Those who received injections, including corticosteroids and prolotherapy, into the joint cavity or around the knee within three months of the screening.
- •5) Those who drained joint fluid by intraarticular injection within three months of the screening.
- •6) Those with current or past history of inflammatory diseases, tumors, trauma, severe valgus and varus degeneration of the knee joint, secondary arthritis, hip joint diseases, or other inflammatory arthritis.
- •7) Those with severe cardiovascular diseases, hepaticpathy, nephropathy, immunodeficiency, diabetes, or hemopathy.
- •8) Those taking immunosuppressants, corticosteroids, cyclosporine, or osteoarthritis medications.
- •9) Those with psychiatric or immunological diseases, or taking medications for these diseases.
- •10) Those with skin allergies, glue allergies, or skin infections on the treated acupoints.
- •11) Pregnant or lactating women.
- •12) Those who have participated in other clinical trials within one month of the screening or who plan to participate in other clinical trials during the study period (however, those who have participated in a non-interventional observational study may participate in this trial if the principal investigator has determined that the prior trial does not affect the efficacy and safety of the investigational medical device).
- •13) Others whom the principal investigator deemed to be ineligible for participating in this trial for other reasons.
研究者
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