Efficacy and Mechanism of Acupuncture on Patients With Chronic Sciatica Using fMRI: A Randomized, Patient-Assessor Blind, Sham-Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Visual analogue scale for bothersomeness
研究概览
简要总结
This research is planned to build a basis about the efficacy and mechanism of acupuncture on pain and emotional disorder in patients with chronic sciatica using fMRI.
详细描述
Clinical research to assess the effect of acupuncture for chronic sciatica on pain and emotional disorder will be processed with randomized, patient-assessor blinding, and sham-acupuncture controlled study design. Sixty eight subjects would be collected and divided into two groups(experimental and placebo, 34 subjects each). Experimental group will undergo with real acupuncture treatment(manual acupuncture + electroacupuncture) and placebo group will undergo with sham acupuncture treatment (acupuncture without skin penetration + electroacupuncture without electrical stimulation) twice a week, for 4 weeks. The effect on parameters related with pain and emotional disorder will be assessed at 1(baseline: just before the beginning of treatment) and 5(primary end point: 1 week after the end of treatment) weeks. Functional magnetic resonance imaging will be also conducted for 52 subjects(experimental and placebo, 20 among 34 subjects each + normal control 12 subjects) at 1 and 5 weeks to seek machanism of acupuncture.
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
- 是
入选标准
- •adults 19 years of age or more and 70 years of age or less
- •clinical diagnosis of chronic sciatica (pain lasting 3 months or more)
- •40mm or more of 100mm VAS for bothersomeness due to sciatica
- •volunteers through announcements and advertisements with written informed consent
排除标准
- •spinal surgery within the past 6 months
- •diagnosis of specific severe diseases resulting in sciatica: malignant tumor, spinal infection, inflammatory sponlylitis
- •progressive neurological deficit or severe neurological signs
- •other chronic diseases which could disturb the effect of treatments and the results of the study: cardiovascular diseases, autoimmune diseases, renal diseases, diabetic neuropathy, dementia, epilepsy
- •inadequate or insafe for the treatment of acupuncture/ electroacupuncture: hemorrhagic diseases, medication of anticoagulant, serious diabetes mellitus vulnerable to infections, serious cardiovascular diseases/ pacemaker, metal materials interior of the body
- •currently or might be pregnant
- •severe mental illness
- •currently participating other clinical trials
- •experience of acupuncture or electroacupuncture treatment, or taking medicines which might affect the symptom of pain such as corticosteroids, narcotics, NSAIDs or considered to be inadequate by the investigators within the past week (But they could be included only after going through 2 weeks of wash out period.)
- •difficulty of writing informed consent
- •inadeguate or insafe for MRI scanning: claustrophobia, metal materials interor of the body
- •other inadequate subjects assessed by the study investigators
研究组 & 干预措施
Real acupuncture
manual acupuncture + electroacupuncuture on acupoints, twice a week, for 4 weeks
干预措施: Real acupuncture (Device)
Sham acupuncture
sham acupuncture (no skin penetration) + placebo electroacupuncture without electrical stimulation on acupoints, twice a week, for 4 weeks
干预措施: Sham acupuncture (Device)
结局指标
主要结局
Visual analogue scale for bothersomeness
时间窗: baseline, 1-1, 1-2, 2-1, 2-2, 3-1, 3-2, 4-1, 4-2, 5, and 8 weeks
change in visual analoge scale for bothersomeness \[range: 0(better)-100(worse) mm\]
次要结局
- Oswestry Disability Index(week 1(before treatment) and week 5(1 week after treatment, primary endpoint))
- Visual analogue scale for pain intensity(baseline, 1-1, 1-2, 2-1, 2-2, 3-1, 3-2, 4-1, 4-2, 5, and 8 weeks)
- Beck Depression Inventory(week 1(before treatment) and week 5(1 week after treatment, primary endpoint))
- State-Trait Anxiety Inventory(week 1(before treatment) and week 5(1 week after treatment, primary endpoint))
- blood oxygenation level dependent in Magnetic Resonance Image, functional(week 1(before treatment) and week 5(1 week after treatment, primary endpoint))
- EuroQol 5-Dimension(week 1(before treatment) and week 5(1 week after treatment, primary endpoint))
- Adverse events(baseline, 1-1, 1-2, 2-1, 2-2, 3-1, 3-2, 4-1, 4-2, 5, and 8 weeks)
- Coping Strategy Questionnaire(week 1(before treatment) and week 5(1 week after treatment, primary endpoint))
研究者
Mi-Yeon Song
Professor, K.M.D., Ph.D.
Kyung Hee University Hospital at Gangdong