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| Name | Class |
|---|---|
| Kyung Hee University Hospital at Gangdong | OTHER |
| DongGuk University | OTHER |
| Daegu Korean Medicine Hospital of Daegu Haany University | OTHER |
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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.
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 acupuncture (STEA) group. Both groups will receive treatment on predefined 23 acupoints once a week for 8 weeks, and needle with thread removed will be used in STEA group instead of normal TEA. 100 mm visual analogue scale (VAS) for low back pain will be assessed as a primary outcome. Also, 100mm VAS for radiating pain, Oswestry disability index (ODI), Rolland Morris disability questionnaire (RMDQ), EQ-5D-5L and global perceived effect (GPE) will be measured as secondary outcomes. All the outcomes will be assessed at baseline, 4 weeks after screening, treatment end (8 weeks, primary end point) and follow-up sessions (12 and 16 weeks).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thread-Embedding Acupuncture (TEA) | Experimental | The TEA group will be treated once a week for 8 weeks, using 29G x 40mm or 29G x 60mm TEA on predefined 23 acupoints selected by expert group according to STRICTA. All other treatment affecting the outcomes will be prohibited during the trial period. All therapeutic procedure will be performed by acupuncture specialists who have received training for the consensus of multicenter. |
|
| Sham Thread-Embedding Acupuncture (STEA) | Sham Comparator | The STEA group will be treated once a week for 8 weeks, using 29G x 40mm or 29G x 60mm sham TEA on predefined 23 acupoints selected by expert group according to STRICTA. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thread-embedding Acupuncture (TEA) | Procedure | The acupoints and size of TEA are as follows:
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline 100mm Pain Visual Analogue Scale (VAS) for low back pain at Week 8 | Measurement instrument for subjective pain | Week 1 (Baseline), Week 4, Week 8 (Primary end point, Treatment end), Week 12, Week 16 (F/U) |
| Measure | Description | Time Frame |
|---|---|---|
| 100mm Pain Visual Analogue Scale (VAS) for radiating pain | Measurement instrument for subjective pain | Week 1 (Baseline), Week 4, Week 8 (Treatment end), Week 12, Week 16 (F/U) |
| Oswestry Disability Index (ODI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Byung-Kwan Seo, PhD., KMD | Kyunghee University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dongguk University Bundang Oriental Hospital | Seongnam-si | Gyeonggi-do | 13601 | South Korea | ||
| Daegu Korean Medicine Hospital of Daegu Haany University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30201029 | Derived | Goo B, Ryoo DW, Kim EJ, Nam D, Lee HJ, Kim JS, Park YC, Baek YH, Seo BK. Clinical research on the efficacy and safety of thread-embedding acupuncture for treatment of herniated intervertebral disc of the lumbar spine: a protocol for a multicenter, randomized, patient-assessor blinded, controlled, parallel, clinical trial. Trials. 2018 Sep 10;19(1):484. doi: 10.1186/s13063-018-2864-4. |
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|
| Sham Thread-embedding Acupuncture (STEA) | Procedure | 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. |
|
Validated questionnaire for disability of low back pain.
| Week 1 (Baseline), Week 4, Week 8 (Treatment end), Week 12, Week 16 (F/U) |
| EuroQol-5 dimensions-5 level (EQ-5D-5L) | Standardized instrument for generic health status | Week 1 (Baseline), Week 4, Week 8 (Treatment end), Week 12, Week 16 (F/U) |
| Roland-Morris Disability Questionnaire (RMDQ) | Health status measure for low back pain | Week 1 (Baseline), Week 4, Week 8 (Treatment end), Week 12, Week 16 (F/U) |
| Global Perceived Effect (GPE) | Assessment of change in the patient's chief complaint | Week 4, Week 8 (Treatment end), Week 12, Week 16 (F/U) |
| Daegu |
| 42158 |
| South Korea |
| Kyunghee University Medical Center | Seoul | 02447 | South Korea |
| Kyung Hee University Hospital at Gangdong | Seoul | 05278 | South Korea |
| ID | Term |
|---|---|
| D007405 | Intervertebral Disc Displacement |
| D017116 | Low Back Pain |
| D011843 | Radiculopathy |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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