The Effect of Early MSAT Treatment on Radiating Pain in the Upper Extremity Caused by Traffic Accidents: A Pragmatic 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
- 1
- 主要终点
- Numeric Rating Scale(NRS) of radiating pain
研究概览
简要总结
This study is a open-label, randomized controlled trail. condition/disease: radiating pain in the upper extremity. 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, we conducted a randomized controlled trials to verify the efficacy and safety of MSAT on radiating pain in the upper extremity. From November 2023 to December 2024, we collected 100 inpatients who were suffered from radiating pain in the upper extremity with the numeric rating scale(NRS) over 5 after injury by acute traffic accident(TA). For experimental group(n=50), we conducted 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 MSAT was conducted. For these two groups, we compared NRS, Visual Analogue Scale(VAS), Neck Disability Index(NDI), C-SPINE MRI, EuroQol 5-Dimension (EQ-5D) and 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 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 19-69 years on the date they sign the consent form.
- •Patients who are suffered byradiating pain in the upper extremity that occurred within 3 days after traffic accident.
- •Patients who are hospitalized due to traffic accident.
- •Patients with NRS of radiating 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 radiating pain: malignancy, spondylitis, inflammatory spondylitis, etc.
- •Patients with progressive neurological deficits or with severe neurological symptoms.
- •Patients with medical history of cervical surgery or thoracic surgery within the last three weeks.
- •Patients who have radiating pain in upper extremity before the traffic accident.
- •Patients with a specific serious disease that may interfere with the interpretation of the therapeutic effects or results: malignancy, spondylitis, inflammatory spondylitis, 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 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.
研究组 & 干预措施
Korean medical treatment
The control group were received Korean medical treatment everyday after hospitalization: acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine.
干预措施: Korean medical treatment (Procedure)
Cervical motion style acupuncture treatment(Trapezius, Rhomboid, Scalene)
The MSAT group recieved 3 sessions of MSAT; on second, third, fourth day after hospitalization. A trained doctor of Korean medicine with at least 3 years of clinical experience conducted the MSAT.
The MSAT group were also treated with other Korean medical treatment everyday: acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine.
干预措施: Cervical motion style acupuncture treatment(Trapezius, Rhomboid, Scalene) (Procedure)
Cervical motion style acupuncture treatment(Trapezius, Rhomboid, Scalene)
The MSAT group recieved 3 sessions of MSAT; on second, third, fourth day after hospitalization. A trained doctor of Korean medicine with at least 3 years of clinical experience conducted the MSAT.
The MSAT group were also treated with other Korean medical treatment everyday: acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine.
干预措施: Korean medical treatment (Procedure)
结局指标
主要结局
Numeric Rating Scale(NRS) of radiating pain
时间窗: Screening, Baseline(day2), day3, day4, day5, Discharge 1 day, 1month after enrollment, 3month after enrollment
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 leg 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
- VAS of Radiating pain(Baseline(day2), day3, day4, day5, Discharge 1 day, 1month after enrollment, 3month after enrollment)
- NRS of Neck pain(Baseline(day2), day3, day4, day5, Discharge 1 day, 1month after enrollment, 3month after enrollment)
- Location of Radiating pain(Baseline(day2), day3, day4, day5, Discharge 1 day, 1month after enrollment, 3month after enrollment)
- C-SPINE MRI(Taken within ±14 days of hospitalization)
- NDI(Baseline(day2), day5, Discharge 1 day, 1month after enrollment, 3month after enrollment)
- EQ-5D(Baseline(day2), day5, Discharge 1 day, 1month after enrollment, 3 months after enrollment)
- PGIC(day5, Discharge 1 day, 1month after enrollment, 3 months after enrollment)