The Effect of Early MSAT Treatment on Sciatica Caused by Traffic Accidents : A Pragmatic Randomized Controlled Pilot Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Numeric Rating Scale of sciatica(NRS of sciatica)
研究概览
简要总结
The investigators would like to conduct a pilot study prior to a practical randomized control study on the effectiveness of initial MSAT treatment on inpatients complaining of radiating pain and abnormal sensation in the lower extremities caused by traffic accidents.
详细描述
The stimulation of the nerve roots due to physicochemical causes can lead to symptoms along the distribution area of those nerves, such as radiating pain, numbness, a sensation of heat, dullness in sensation, muscle weakness, and more. While radiating pain and abnormal sensations typically arise from lumbar disc herniation, they can also result from peripheral nerve entrapment, like in radiculopathy. Traditional Korean medicine treatments for radiating pain involve acupuncture, pharmacoacupuncture, moxibustion, cupping and Chuna therapy.
Motion Style Acupuncture Treatment (MSAT) combines traditional acupuncture with neurophysiological theories, focusing on administering acupuncture at the affected area and subsequently involving active or passive movements. Studies have shown the efficacy of MSAT in treating various acute and chronic neuromuscular disorders like low back pain, brachial plexus injury, and temporomandibular joint disorders. Although there have been reports of the effectiveness of pelvic MSAT treatment in patients complaining of lumbar and radiating pain due to lumbar disc herniation, research on the initial effects of MSAT treatment specifically targeting traffic accident victims is still lacking. MSAT has been developed as an emergency acupuncture method that enhances blood circulation by adding movement to traditional acupuncture, offering quick pain relief and restoring range of motion.
Given the significant impact of a traffic accident, positive effects could be anticipated in alleviating radiating pain and restoring reduced range of motion through MSAT, especially when these symptoms arise following such a traumatic event.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a person who has no problem in language communication
- •men and women between the ages of 19 and 69
- •a patient hospitalized for treatment in a car accident
- •A person who complains of radiating pain or abnormal sensation in the lower extremities within three days after a traffic accident
- •A person with a lower extremity radiating pain or abnormal sensation of NRS (Numeric Rating Scale) 5 or higher
- •A person who voluntarily agrees to participate in clinical trials and signs a consent form
排除标准
- •Patient diagnosed with certain serious diseases that may cause radiation pain: malignant tumors, spinal fractures, spinal infections, inflammatory spondylitis, etc
- •Patient with progressive neurological deficits or severe neurological symptoms such as Mami syndrome
- •Patient who has undergone surgery, procedures, or is scheduled to undergo surgery on the lumbar spine or lower extremities within the last 3 weeks
- •Patient with other chronic conditions that may interfere with interpretation of treatment effects or results: cardiovascular disease, kidney disease, active hepatitis, diabetic neuropathy, dementia, severe mental illness, epilepsy, etc
- •Patient who may be inadequate or unsafe with acupuncture treatment: hemorrhagic disease, people on anticoagulant therapy, people with severe cardiovascular disease, pregnancy, and infection Severe diabetic patients, seizure disorders, etc. that are concerned
- •Patient currently taking steroids, immunosuppressants, mental illness medications or other medications that may affect research results
- •Patient Participating in clinical trials other than observational studies without therapeutic intervention
- •Patient who has difficulty filling out consent forms to participate in research
- •Patient deemed difficult to conduct this clinical study when judged by the research director
研究组 & 干预措施
Integrative Korean Medicine Treatment group(IKMT group)
干预措施: Integrative Korean Medicine Treatment (Procedure)
MSAT group
干预措施: Integrative Korean Medicine Treatment (Procedure)
MSAT group
干预措施: lower limb motion style acupuncture treatment (Procedure)
结局指标
主要结局
Numeric Rating Scale of sciatica(NRS of sciatica)
时间窗: visit 1 (Admission 1 day), visit 2 (Hospital day 2), visit 3(Hospital day 3), visit 4 (Hospital day 4), visit 5 (Hospital day 5), visit 6 (Discharge 1 day), visit 7 (13 day after admission)
The degree of radiation pain or abnormal sensation in the patient is evaluated through a numerical pain scale. The numerical pain scale is an index expressed by objectifying the degree of subjective pain into numbers for patients over 12 years of age who can communicate and understand the concept of numbers. The patient's pain level is quantified by zero pain and ten pain that cannot be tolerated as death, and is mild (1-4 points), moderate (5-6 points), and severe (7-10 points).
次要结局
- NRS of Lower back pain(NRS of LBP)(visit 1 (Admission 1 day), visit 2 (Hospital day 2), visit 3(Hospital day 3), visit 4 (Hospital day 4), visit 5 (Hospital day 5), visit 6 (Discharge 1 day), visit 7 (13 day after admission))
- Patient Global Impression of Change(PGIC)(visit 1 (Admission 1 day), visit 2 (Hospital day 2), visit 3(Hospital day 3), visit 4 (Hospital day 4), visit 5 (Hospital day 5), visit 6 (Discharge 1 day), visit 7 (13 day after admission))
- Oswestry disability index(ODI)(visit 1 (Admission 1 day), visit 2 (Hospital day 2), visit 3(Hospital day 3), visit 4 (Hospital day 4), visit 5 (Hospital day 5), visit 6 (Discharge 1 day), visit 7 (13 day after admission))
- European Quality of Life-5 Dimensions(EQ-5D)(visit 1 (Admission 1 day), visit 2 (Hospital day 2), visit 3(Hospital day 3), visit 4 (Hospital day 4), visit 5 (Hospital day 5), visit 6 (Discharge 1 day), visit 7 (13 day after admission))
- Severity of L-spine HIVD(Herniated intervertebral disc) or lumbar stenosis on MRI(through study completion, an average of 1 month)
- Lumbar Range of motion(Lumbar ROM)(visit 1 (Admission 1 day), visit 2 (Hospital day 2), visit 3(Hospital day 3), visit 4 (Hospital day 4), visit 5 (Hospital day 5), visit 6 (Discharge 1 day), visit 7 (13 day after admission))
- Adverse event(AE)(visit 1 (Admission 1 day), visit 2 (Hospital day 2), visit 3(Hospital day 3), visit 4 (Hospital day 4), visit 5 (Hospital day 5), visit 6 (Discharge 1 day), visit 7 (13 day after admission))
- Straight Leg Raise Test(SLRT)(visit 1 (Admission 1 day), visit 2 (Hospital day 2), visit 3(Hospital day 3), visit 4 (Hospital day 4), visit 5 (Hospital day 5), visit 6 (Discharge 1 day), visit 7 (13 day after admission))
研究者
In-Hyuk Ha, KMD
Director
Jaseng Medical Foundation