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临床试验/NCT04598854
NCT04598854已完成不适用

The Investigation of Therapeutic Effect and Molecular Mechanism After Intravascular Laser Irradiation of Blood for Osteoarthritis of Knee

Tri-Service General Hospital1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2020年10月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
17
试验地点
1
主要终点
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)

研究概览

简要总结

This research is designed through randomization, control, and double-blind trial to explore the clinical effectiveness of intravenous laser irradiation of blood for knee degenerative arthritis; and to explore the changes in body's balance function. Furthermore to establish a new way of clinical rehabilitation therapy. The research will further study the special biomarker to investigate the mechanism of low-energy intravenous laser therapy for osteoarthritis.

详细描述

Background This research is designed through randomization, control, and double-blind trial to explore the clinical effectiveness of intravenous laser irradiation of blood for knee degenerative arthritis; and to explore the changes in body's balance function. Furthermore to establish a new way of clinical rehabilitation therapy. The research will further study the special expression of blood cells after the treatment and as well as the molecular mechanism of low-energy intravenous laser therapy on hematopoietic stem cells. fold of the sun. The light accelerates blood and cells circulation in the human body, so that protein molecular structure would promote changes. Pain control is indicated in such treatment, but still lacking evidence of improving the symptoms of degenerative knee arthritis.

Purpose This research is designed through randomization, control, and double-blind trial to explore the clinical effectiveness of intravenous laser irradiation of blood for knee degenerative arthritis; and to explore the changes in body's balance function. Furthermore to establish a new way of clinical rehabilitation therapy. The research will further study the special biomarker to investigate the mechanism of low-energy intravenous laser therapy for osteoarthritis.

Method The investigators plan to recruit 20 patients who are between the ages of 50 to 75 years old, but younger than 75 years old. The participants are required to have clear conscious and be able to communicate. Their symptoms of degenerative arthritis could be one or both knees which last more than six months; with knee pain greater than 4 points when walking. The treatment group will receive an intravenous helium-neon laser phototherapy. A vein indwelling needle will be placed in their veins located in the upper elbow, and the laser fiber catheter will be introduced through the indwelling cannula. The power is set between 2.5 ~ 3.0Mw, 60 minutes each time, once a day for five consecutive days. The steps for the control group are the same, except that the output power is adjusted to zero intensity. This plan will be explained to the patient in detail during the outpatient visit and patients will sign the consent form upon agreement. Before intravenous laser irradiation, three days, one month, and three months after the therapy, 20 ml of autologous peripheral venous blood need to be drawn for basic blood tests and biomarker tests. At the same time, the clinical functions of patients will be evaluated, including visual analogous scale, Lequesne 's severity index, WOMAC scale, and balance function test.

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
Double (Participant, Investigator)

入排标准

年龄范围
50 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • clear conscious and be able to communicate.
  • the symptoms of degenerative arthritis could be one or both knees which last more than six months
  • with knee pain greater than 4 points when walking

排除标准

  • had ever received intraarticular injection with hyaluronic acid or steroid within 6 months
  • had ever received nonsteroidal anti-inflammatory drugs or steroid therapy within 1 week
  • neoplasm of joint and peripheral soft tissue
  • malignancy
  • had ever received total knee arthroplasty or other major surgery
  • rheumatoid arthritis
  • coagulopathy
  • unable to take balance test due to other chronic disease

结局指标

主要结局

The Western Ontario and McMaster Universities Arthritis Index (WOMAC)

时间窗: 3 months

Score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The higher score means more severity. Measure before intravenous laser irradiation, three days, one month, and three months after the therapy.

Visual Analogue Scale (VAS) of the degree of pain

时间窗: 3 months

with the score ranging from 10 (tremendous pain) to 0 (no pain). Measure before intravenous laser irradiation, three days, one month, and three months after the therapy.

Balance function test

时间窗: 3 months

Test standing balance,including static, dynamic with opening and closing eyes, and single leg stance. Measure before intravenous laser irradiation, three days, one month, and three months after the therapy.

Lequesne 's severity index

时间窗: 3 months

Three domain: pain or discomfort, maximum distance walked, activities of daily living. Score range of 0-26. The higher score means more severity. Measure before intravenous laser irradiation, three days, one month, and three months after the therapy.

次要结局

  • Serum cartilage oligomeric matrix protein (COMP)(3 months)
  • Serum procollagen type II N-terminal propeptide (PIIANP)(3 months)
  • Serum calcitonin gene-related peptide (CGRP)(3 months)
  • Serum Interleukin 6 (IL6)(3 months)
  • The number of synovium-derived stem cell with CD73, CD90, CD105(3 months)
  • Substance P(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Liang-Cheng Chen

Clinical Professor of Department of Physical Medicine and Rehabilitation

Tri-Service General Hospital

研究点 (1)

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