The Efficacy and Safety of Sandbag Self Walking-MSAT on Inpatients With Acute Low Back Pain Caused by Traffic Accidents: A Randomized Controlled Trials
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Numeric Rating Scale(NRS) of Low back pain
研究概览
简要总结
This study is a double blind, randomized controlled trail. condition/disease: acute low back pain treatment/intervention: motion style acupuncture treatment
详细描述
Motion Style Acupuncture Treatment(MSAT) is a therapeutic technique using acupuncture needle created in Jaseng Hospital. This treatment involves patients with musculoskeletal pain to move the part of their body actively during acupuncture treatment under physicians' observation. This treatment is known to relieve the pain and increase the range of motion(ROM). However, there has been no specific value for the effect of this treatment.
So, the investigators conducted a randomized controlled trials to verify the efficacy and safety of Sandbag MSAT. From June 2021 to June 2023, the investigators collected 104 inpatients who were suffered from Low back pain with the numeric rating scale(NRS) over 5 after injury by acute traffic accident(TA). For experimental group(n=52), the investigators conducted MSAT three times(on 2nd, 3rd and 4th day of hospitalization) and other Korean medical treatment. For control group(n=52), just Korean medical treatment except MSAT was conducted. For these two groups, the investigators compared NRS, Visual Analogue Scale(VAS), Range Of Motion(ROM), the amount of pain via NRS(Numeric Rating Scale), VAS(Visual Analogue Scale), ROM(Range Of Motion), Oswestry Disability Index (ODI), and EuroQol 5-Dimension (EQ-5D), EuroQol Visual Analogue Scale (EQ-VAS), Short Form-12 Health Survey version 2, SF-12 v2), The Posttraumatic Stress Disorder Checklist for DSM-5(PCL-5-K), Patient Global Impression of Change (PGIC).
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 19-70 years on the date they sign the consent form
- •Patients who needs hospitalization due to acute low back pain that occurred within 7 days after traffic accident
- •Patients with NRS ≥ 5 for low back pain
- •Patients who provide consent to participate in the trial and return the informed consent form
排除标准
- •Patients with a specific serious disease that may cause spinal pain: malignancy, spondylitis, inflammatory spondylitis, etc.
- •Patients with progressive neurological deficits or with severe neurological symptoms
- •Patients who have had surgery or procedures within the last three weeks
- •The cause of pain is due to soft tissue disease, not the spine: tumors, fibromyalgia, rheumatoid arthritis, gout, etc.
- •Patients with other chronic conditions that may interfere with the interpretation of the therapeutic effects or results: cardiovascular disease, kidney disease, diabetic neuropathy, dementia, epilepsy, etc.
- •Patients who are taking steroids, immunosuppressants, mental illness drugs, or other drugs that may affect the results of the study
- •If acupuncture is inadequate or unsafe: patients with hemorrhagic, receiving anticoagulants, severe diabetes and cardiovascular disease
- •Patients who are pregnant or planning to become pregnant
- •Patients with a serious mental illness
- •Patients who are participated in clinical trials other than observational studies without therapeutic intervention.
- •Patients who are difficult to complete the research participation agreement
- •Other patients whose participation in the trial is judged by a researcher to be problematic.
结局指标
主要结局
Numeric Rating Scale(NRS) of Low back pain
时间窗: Change from baseline NRS at 4 days
The extent of Low back pain and discomfort will be assessed using NRS. NRS is a pain scale in which the patient indicates their subjective pain as a whole number from 0 to 10. The participant is asked to report their low back pain and discomfort using NRS, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'.
次要结局
- Oswestry Disability Index (ODI)(visit2(day2), day of discharge(up to 14days), visit6(1 month after discharge), visit7(3 months after discharge))
- EuroQol 5-Dimension (EQ-5D)(visit2(day2), day of discharge(up to 14days), visit6(1 month after discharge), visit7(3 months after discharge))
- EuroQol Visual Analogue Scale (EQ-VAS)(visit2(day2), day of discharge(up to 14days))
- Patient Global Impression of Change (PGIC)(visit2(day2), day of discharge(up to 14days), visit6(1 month after discharge), visit7(3 months after discharge))
- Adverse events(visit2(day2), visit3(day3), visit4(day4), day of discharge(up to 14days), visit6(1 month after discharge), visit7(3 months after discharge))
- Visual Analogue Scale (VAS) of Low back pain(visit2(day2), visit3(day3), visit4(day4), day of discharge(up to 14days))
- Short Form-12 Health Survey version 2 (SF-12 v2)(visit2(day2), day of discharge(up to 14days), visit6(1 month after discharge), visit7(3 months after discharge))
- The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5-K)(visit2(day2), day of discharge(up to 14days), visit6(1 month after discharge), visit7(3 months after discharge))
- Visual Analogue Scale (VAS) of leg pain(visit2(day2), visit3(day3), visit4(day4), day of discharge(up to 14days))
- Numeric Rating Scale(NRS) of leg pain(visit1(day1), visit2(day2), visit3(day3), visit4(day4), day of discharge(up to 14days), visit6(1 month after discharge), visit7(3 months after discharge))
- Physical examination (Lumbar range of motion)(visit2(day2), visit3(day3), visit4(day4), day of discharge(up to 14days))
研究者
In-Hyuk Ha, KMD
Director
Jaseng Medical Foundation