Clinical research on the efficacy and safety of thread-embedding acupuncture for treatment of herniated intervertebral disc of the lumbar spine: A multicenter, randomized, patient–assessor blinded, controlled, parallel, clinical trial

Kyung Hee University0 个研究点目标入组 70 人开始时间: 待定最近更新: 2020年2月24日

试验速览

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•1. Male or female adults aged 19-70
•2. Radiating pain matched with severer abnormality than bulging shown by CT or MRI on lumbar spine
•3. 40 or higher low back pain on 100mm pain visual analogue scale
•4. Volunteers who agree to participate and sign the Informed Consent Form, following a detailed explanation of clinical trials

•1. Congenital abnormalities or surgical history on lumbar regions
•2. Red flag signs that may be suspected of cauda equina syndrome, such as bladder and bowel dysfunction or saddle anesthesia
•3. Tumor, fracture or infection in lumbar regions
•4. Injection treatment on lumbar regions within 1 week
•5. Psychiatric disorder currently undergoing treatment such as depression or schizophrenia
•6. Inappropriate condition for thread-embedding acupuncture due to skin disease or hemostatic disorder (PT INR > 2.0 or taking anticoagulant)
•7. Other diseases that could affect or interfere with therapeutic outcomes, including severe gastrointestinal disease, cardiovascular disease, hypertension, diabetes, renal disease, liver disease or thyroid disorder
•8. Contraindication of acetaminophen including intercurrent disease, hypersensitivity reaction or other medication
•9. Pregnant women or other inappropriate condition for thread-embedding acupuncture
•10. Heavy drinking (more than 3 cups per day) that could cause hepatotoxicity with acetaminophen

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