Effectiveness and Safety of Acupotomy on Back and/or Leg Pain in Patients with Lumbar Disc Herniation: A Multicenter Randomized, Controlled, Assessor-Blinded, Clinical Trial

Korea Institute of Oriental Medicine0 个研究点目标入组 146 人开始时间: 待定最近更新: 2019年3月11日

试验速览

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•1) Who aged 19-70 years
•2) Who was confirmed diagnosis of lumbar herniated disc by CT(Computed Tomography) or MRI(magnetic resonance imaging) within 5 years
•3) Who with symptoms of lumbar dics herniation, such as low back pain, radiating pain in low extremity, paraesthesia in lower extremity, weakness in lower extremity, and etc.
•4) Who scored more than 30mm on VAS(Visual Analogue Scale) at the time of screening
•5) Who have no problems with language, expression and concentration
•6) Who be able and willing to comply with intervention and follow-up evaluation
•7) Who voluntary agreement via written informed consent after being provided with an explanation regarding the purpose and characteristics of this study

•1) Hypersensitive reaction to previous acupuncture treatment, metal allergy, severe atopy, keloid, and other skin hypersensitivities
•2) Patients requiring surgery because of cauda equina syndrome, or neurological symptoms such as motor and/or sensory paralysis
•3) History of plate internal fixation or spinal fusion operation
•4) Suffering from pain in another region that is greater than the pain of lumbar and/or lower extremity region
•5) Using drug to pain relief, such as narcotic analgesics, anticonvulsants, corticosteroids, and etc.
•6) History of participainting another clinical trial with intervention in past 3 months
•7) Pregnant woman, lactating woman, or woman in childbearing years who plans on being pregnant
•8) History of neurotic or major psychiatric disability, or alcoholism or drug abuse, or severe underlying disease requiring active treatment or being treated currently
•9) Those who have a hemorrhagic disease or cardiovascular disease, and/or factors that can affect hemostasis such as anti-coagulant or anti-platelet drug
•10) Patients who are considered to be inappropriate for the study by the researcher

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