Clinical Research on the Efficacy of Thread-embedding Acupuncture on Herniated Intervertebral Disc of Lumbar Spine
NCT03236753 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70
Last updated 2020-02-06
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 quality of life.
Conditions
- Lumbar Disc Herniation
Interventions
- PROCEDURE
-
Thread-embedding Acupuncture (TEA)
The acupoints and size of TEA are as follows: 1. Both EX-B2 of herniated intervertebral disc level, its upper level and its lower level (6 acupoints): perpendicular insertion, 4cm 2. Both BL24: transverse insertion toward L1 level along the erector muscle of spine, 6cm 3. Both BL25: transverse insertion toward iliac crest, 4cm 4. Both BL26: transverse insertion toward L1 level along the erector muscle of spine, 6cm 5. Both BL26: oblique insertion toward iliolumbar ligament, 6cm 6. Both EX-B7: oblique insertion toward gluteus medius muscle, 6cm 7. Both BL28: oblique insertion toward sacroiliac ligament, 6cm 8. Both GB30: perpendicular insertion, 6cm 9. Symptomatic side GB34, BL57 and ST36: oblique insertion toward foot, 4cm
- PROCEDURE
-
Sham Thread-embedding Acupuncture (STEA)
All procedure of STEA group, including acupoints and size of TEA will be same as that of TEA group. However, thread-removed TEA will be used for STEA group instead of normal TEA, and removing procedure of thread will be performed aseptic and secretly for patient-blinding and prevention of infection.
Sponsors & Collaborators
-
Kyung Hee University Hospital at Gangdong
collaborator OTHER -
DongGuk University
collaborator OTHER -
Daegu Korean Medicine Hospital of Daegu Haany University
collaborator OTHER -
Kyunghee University Medical Center
lead OTHER
Principal Investigators
-
Byung-Kwan Seo, PhD., KMD · Kyunghee University Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 19 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-08-11
- Primary Completion
- 2019-06-04
- Completion
- 2019-07-30
Countries
- South Korea
Study Locations
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