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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 4
- 主要终点
- Change from Baseline 100mm Pain Visual Analogue Scale (VAS) for low back pain at Week 8
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Thread-Embedding Acupuncture (TEA)
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.
干预措施: Thread-embedding Acupuncture (TEA) (Procedure)
Sham Thread-Embedding Acupuncture (STEA)
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.
干预措施: Sham Thread-embedding Acupuncture (STEA) (Procedure)
结局指标
主要结局
Change from Baseline 100mm Pain Visual Analogue Scale (VAS) for low back pain at Week 8
时间窗: Week 1 (Baseline), Week 4, Week 8 (Primary end point, Treatment end), Week 12, Week 16 (F/U)
Measurement instrument for subjective pain
次要结局
- Global Perceived Effect (GPE)(Week 4, Week 8 (Treatment end), Week 12, Week 16 (F/U))
- Oswestry Disability Index (ODI)(Week 1 (Baseline), Week 4, Week 8 (Treatment end), Week 12, Week 16 (F/U))
- EuroQol-5 dimensions-5 level (EQ-5D-5L)(Week 1 (Baseline), Week 4, Week 8 (Treatment end), Week 12, Week 16 (F/U))
- 100mm Pain Visual Analogue Scale (VAS) for radiating pain(Week 1 (Baseline), Week 4, Week 8 (Treatment end), Week 12, Week 16 (F/U))
- Roland-Morris Disability Questionnaire (RMDQ)(Week 1 (Baseline), Week 4, Week 8 (Treatment end), Week 12, Week 16 (F/U))
研究者
Byung-Kwan Seo
PhD., KMD
Kyunghee University Medical Center