Clinical Research on the Efficacy of Thread-embedding Acupuncture on Herniated Intervertebral Disc of Lumbar Spine

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Clinical Research on the Efficacy and Safety of Thread-embedding Acupuncture for Treatment of Herniated Intervertebral Disc of Lumbar Spine; A Multicenter, Randomized, Patient-assessor Blinded, Controlled, Parallel Clinical Trial

Conditions
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Lumbar Disc Herniation

Intervention / Treatment
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* Procedure: Thread-embedding Acupuncture (TEA)
* Procedure: Sham Thread-embedding Acupuncture (STEA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thread-Embedding Acupuncture (TEA)<br>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. | Procedure: Thread-embedding Acupuncture (TEA)<br>* The acupoints and size of TEA are as follows: Both EX-B2 of herniated intervertebral disc level, its upper level and its lower level (6 acupoints): perpendicular insertion, 4cm Both BL24: transverse insertion toward L1 level along the erector muscle of spine, 6cm Both BL25: transverse insertion toward iliac crest, 4cm Both BL26: transverse insertion toward L1 level along the erector muscle of spine, 6cm Both BL26: oblique insertion toward iliolumbar ligament, 6cm Both EX-B7: oblique insertion toward gluteus medius muscle, 6cm Both BL28: oblique insertion toward sacroiliac ligament, 6cm Both GB30: perpendicular insertion, 6cm Symptomatic side GB34, BL57 and ST36: oblique insertion toward foot, 4cm<br>|
| Sham Comparator: Sham Thread-Embedding Acupuncture (STEA)<br>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. | Procedure: Sham Thread-embedding Acupuncture (STEA)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thread-Embedding Acupuncture, Herniated Intervertebral Disc of Lumbar Spine, Low Back Pain, Radiculopathy