The Effectiveness and Safety of T-MSAT on Inpatients With Acute Low Back Pain Caused by Traffic Accidents : A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 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 single blind, randomized controlled trial. condition/disease: acute low-back pain treatment/intervention: Motion Style Acupuncture Treatment using Traction (T-MSAT)
详细描述
Motion Style Acupuncture Treatment(MSAT) is a therapeutic technique using acupuncture needle created in Jaseng Hospital. T-MSAT(Motion style acupuncture treatment using traction) is a kind of MSATs, and a treatment that improves musculoskeletal problems by pulling the patient's body through the device and giving instructions for walking while being acupuncture.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 pain and improve musculoskeletal disfunctions. However, there has been no specific studies for the effect of this treatment.
So, investigators conduct a randomized controlled trials to verify the effectiveness and safety of T-MSAT. From September 2020 to March 2021, investigators recruit 100 inpatients who are suffered from acute low-back pain with the numeric rating scale(NRS) over 5 by traffic accident(TA). For experimental group(n=50), investigators conduct T-MSAT three times(on 2nd, 3rd and 4th day of hospitalization) and other Korean medical treatment. For control group(n=50), just Korean medical treatment except T-MSAT is conducted. For these two groups, investigators compare NRS(Numeric Rating Scale), Visual Analogue Scale(VAS), Range Of Motion(ROM), , Oswestry Disability Index(ODI), the 12-Item Short Form Health Survey(SF-12), and PTSD Checklist for DSM(Diagnostic and Statistical Manual of Mental Disorders, DSM)-5(PCL-5)
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 with NRS ≥ 5 for low-back pain
- •Patients who needs hospitalization due to acute low-back pain that occurred within 7 days after traffic accident
- •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 acute low-back pain: malignancy, fracture of lumbar spine, etc.
- •Patients with progressive neurological deficits or with severe neurological symptoms
- •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 difficult to walk due to leg disorder unrelated to low-back pain
- •Patients who are taking steroids, immunosuppressants, mental illness drugs, or other drugs that may affect the results of the study
- •Patients who are pregnant, planning to become pregnant, or are breastfeeding
- •Patients who have had surgery or procedures of lumbar spine within the last three weeks
- •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 VAS at 4 days
The extent of acute low-back pain and discomfort was 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 participants are 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
- Range of movement (ROM) of left rotation(Baseline, day3, day4, day of discharge(up to 14days))
- Range of movement (ROM) of flexion(Baseline, day3, day4, day of discharge(up to 14days))
- Range of movement (ROM) of right lateral flexion(Baseline, day3, day4, day of discharge(up to 14days))
- Range of movement (ROM) of right rotation(Baseline, day3, day4, day of discharge(up to 14days))
- Visual Analogue Scale (VAS) of low-back pain(Baseline, day3, day4, day of discharge(up to 14days))
- Range of movement (ROM) of left lateral flexion(Baseline, day3, day4, day of discharge(up to 14days))
- Numeric Rating Scale(NRS) of leg pain(Baseline, day3, day4, day of discharge(up to 14days), week12)
- Patient Global Impression of Change (PGIC)(day4, day of discharge(up to 14days), week12)
- Adverse events(Baseline, day3, day4, day of discharge(up to 14days), week12 (every visit))
- Numeric Rating Scale(NRS) of low-back pain(baseline(day1), day2, day3, day4, day of Discharge(up to 14days), week 12)
- Visual Analogue Scale (VAS) of leg pain(Baseline, day3, day4, day of discharge(up to 14days))
- Range of movement (ROM) of extension(Baseline, day3, day4, day of discharge(up to 14days))
- Oswestry Disability Index (ODI)(Baseline, day4, day of discharge(up to 14days), week12)
- 12-item Short-Form Health Survey (SF-12)(Baseline, day4, day of discharge(up to 14days), week12)
- Drug Consumption(Baseline, day3, day4, day of discharge(up to 14days), week12 (every visit))
- Korean version of The Posttraumatic Stress Disorder Checklist for DSM-5(PCL-5-K)(Baseline, day4, day of discharge(up to 14days), week12)
研究者
In-Hyuk Ha, KMD
Director
Jaseng Medical Foundation