Status:
COMPLETED
Clinical Research on the Efficacy of Thread-embedding Acupuncture on Herniated Intervertebral Disc of Lumbar Spine
Lead Sponsor:
Kyunghee University Medical Center
Collaborating Sponsors:
Kyung Hee University Hospital at Gangdong
DongGuk University
Conditions:
Lumbar Disc Herniation
Eligibility:
All Genders
19-70 years
Phase:
NA
Brief Summary
This clinical trial is designed to evaluate the efficacy and safety of thread-embedding acupuncture for treatment of lumbar herniated intervertebral disc (L-HIVD) by assessing pain, function, and qual...
Detailed Description
Seventy patient between the ages of 19 and 70 with L-HIVD will be recruited by eligibility criteria and randomly allocated to the thread-embedding acupuncture (TEA) group and sham thread-embedding acu...
Eligibility Criteria
Inclusion
- Male or female adults aged 19-70
- Radiating pain matched with severer abnormality than bulging shown by CT or MRI on lumbar spine
- 40 or higher low back pain on 100mm pain VAS
- Volunteers who agree to participate and sign the Informed Consent Form, following a detailed explanation of clinical trials
Exclusion
- Congenital abnormalities or surgical history on lumbar regions
- Red flag signs that may be suspected of cauda equina syndrome, such as bladder and bowel dysfunction or saddle anesthesia
- Tumor, fracture or infection in lumbar regions
- Injection treatment on lumbar regions within 1 week
- Psychiatric disorder currently undergoing treatment such as depression or schizophrenia
- Inappropriate condition for thread-embedding acupuncture due to skin disease or hemostatic disorder (PT INR \> 2.0 or taking anticoagulant)
- 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
- Contraindication of acetaminophen including intercurrent disease, hypersensitivity reaction or other medication
- Pregnant women or other inappropriate condition for thread-embedding acupuncture
- Heavy drinking (more than 3 cups per day) that could cause hepatotoxicity with acetaminophen
Key Trial Info
Start Date :
August 11 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2019
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03236753
Start Date
August 11 2017
End Date
July 30 2019
Last Update
February 6 2020
Active Locations (4)
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1
Dongguk University Bundang Oriental Hospital
Seongnam-si, Gyeonggi-do, South Korea, 13601
2
Daegu Korean Medicine Hospital of Daegu Haany University
Daegu, South Korea, 42158
3
Kyunghee University Medical Center
Seoul, South Korea, 02447
4
Kyung Hee University Hospital at Gangdong
Seoul, South Korea, 05278