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临床试验/NCT04356651
NCT04356651已完成不适用

Efficacy of Fu's Subcutaneous Needling for Knee Osteoarthritis: a Single-blind and Randomized-controlled Trial

China Medical University Hospital2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2020年7月7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
32
试验地点
2
主要终点
Visual Analog Scales

研究概览

简要总结

The population affected by degenerative knee arthritis is very large. The investigator performed Fu's subcutaneous needling (FSN). This experiment used a randomized single-blind experiment to assess the immediate, short-term and long-term effects of Fu's subcutaneous needling (FSN) therapy on patellar pain in patients with degenerative arthritis.

详细描述

The population affected by degenerative knee arthritis is very large. According to a survey conducted by the Ministry of Health and Welfare, the prevalence of osteoarthritis of the knee in Taiwan is about 3.5 million people, accounting for about 15% of the total population. Its effects are a heavy burden on socio-economic costs, and in addition to being included in medical expenses, serious cases can lead to incapacity to work; therefore, the disease is an important factor in causing disability and disability First, it is worth our attention.

Floating needle is a kind of dry needle therapy, which has been used in the treatment of degenerative arthritis for more than 20 years. It has been clearly annotated in the treatment strategy that it uses disposable floating needle needles at the superficial subcutaneous fascia, Parallel to the muscle to sweep away, and with reperfusion activities, muscle pain caused by muscle fascia and soft tissue pain with immediate and good pain relief effect, but still lack of treatment and rigorous evaluation of the establishment.

For the reasons of the degenerative arthritis pain, the clinical observation is not entirely due to the cause of joint deformity or cartilage damage, soft tissue lesions around the knee is also a common source of pain, the use of floating needle for the diagnosis of soft tissue injury , And observed its efficacy, which is also the core of this study.

This experiment used a randomized single-blind experiment to assess the immediate, short-term and long-term effects of floating needle therapy on patellar pain in patients with degenerative arthritis. The assessment tools included the VAS, WOMAC , Lesquesne index, the Muscle Tension Changes in the Lower Extremities, and Gyko .

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
None

入排标准

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

入选标准

  • 1.Volunteers who are older than 50 years old and can cooperate with the experiment.
  • 2.Established diagnosis of unilateral or bilateral degenerative knee arthritis. 3.There is a local trigger point around the unilateral or bilateral knee joint which on the muscle of Vastus lateralis, Vastus medialis, Gastrocnemius, or Tibialis anterior.

排除标准

  • 1.There are contraindications to general treatment, such as serious medical problems, recent serious trauma, or pregnant women.
  • 2.There has been a history of drug abuse (including excess alcohol) that affects pain assessors.
  • 3.Have received knee surgery. 4.People with central or peripheral nerve disease. 5.Cognitive impairment, unable to cooperate with the experimenter. 6.Patients currently receiving other treatments for knee osteoarthritis

结局指标

主要结局

Visual Analog Scales

时间窗: 1 day

The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. This tool used to help a person rate the intensity of certain sensations and feelings, such as pain. A straight line of 100mm is actually marked with 0 mm on the far left and 100mm on the far right. Two faces are drawn on both ends. Explain to the patient that 0 mm means no pain and 100 mm means very painful. From the left end The right shift indicates more and more pain. Take a pen and let the patient draw a short line vertically on the line, representing his painful position, and record the measured cm value. In this test, if the score of the subject decreases, it can represent the treatment is helpful for the improvement of the patient's pain.

GyKo

时间窗: 1 day

GyKo is an inertial measurement tool for the analysis of the movement of any body segment

Lequesne'Index

时间窗: 1 day

A pain scale measures a patient's pain intensity or other features.

Muscle tension

时间窗: 1 day

Muscle tension is the muscle's resistance to passive stretch during resting state. The measuring tool called Myotone will calculate three parameters such as tone, elasticity and stiffness automatically and get a value to represent the muscle tension. If the value decrease, it can represent the treatment is helpful for the subjective muscle relax.

Pressure Pain Threshold

时间窗: 1 day

Pressure pain threshold (PPT) is defined as the minimum force applied which induces pain. This measure has proven to be commonly useful in evaluating tenderness symptom

WOMAC

时间窗: 1 day

The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68).

次要结局

未报告次要终点

研究者

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

Li-Wei Chou

Minister of Rehabilitation

China Medical University Hospital

研究点 (2)

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