The Efficacy and Safety of Non-resistance Manual Therapy in Inpatients With Acute Neck Pain Caused by Traffic Accidents: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Numeric Rating Scale(NRS) of neck pain
研究概览
简要总结
Non-resistance therapy is a combination of muscle compression relaxation technique and joint mobilization in patients with acute neck pain caused by traffic accidents. This study is to evaluate the effectiveness and safety of non-resistance therapy for pain and function problems in patients complaining of acute neck pain induced by traffic accidents.
So, investigators conduct a randomized controlled trials to verify the effectiveness and safety of non-resistance therapy. From December 2020 to May 2021, investigators recruit 120 inpatients who are suffered from acute neck pain with the numeric rating scale(NRS) over 5 by traffic accident(TA).
The Korean medical treatment group(n=60) receives daily acupuncture, herbal medicine, and chuna treatment as inpatient treatment from hospitalization until discharge. For the non-resistance therapy group(n=60), the korean medical treatment is performed in the same manner, but additional non-resistance therapy is performed once a day from the 2nd day to the 5th day of hospitalization.
Baseline is the time point before treatment for non-resistance therapy on the second day of hospitalization, and the primary endpoint is the time point after treatment on the 5th day (v5) after hospitalization.
For these two groups, investigators compare NRS(Numeric Rating Scale), Visual Analogue Scale(VAS), Range Of Motion(ROM), Neck Disability Index(NDI), 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 neck pain
- •Patients who needs hospitalization due to acute neck 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 neck 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 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 cervical spine within the last three weeks
- •Patients with a serious mental illness
- •Patients who has not passed one month since the end of participation in other clinical studies, or plan to participate in other clinical studies during the study participation and follow-up period within 12 weeks
- •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
Non-resistance therapy
From the 2nd to 5th day of hospitalization, once a day, 4 times of non-resistance therapy is administered. And non-resistance therapy group is also treated with other Korean integrative medicine treatment everyday: acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine.
干预措施: non-resistance therapy (Other)
Non-resistance therapy
From the 2nd to 5th day of hospitalization, once a day, 4 times of non-resistance therapy is administered. And non-resistance therapy group is also treated with other Korean integrative medicine treatment everyday: acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine.
干预措施: acupuncture (Other)
Non-resistance therapy
From the 2nd to 5th day of hospitalization, once a day, 4 times of non-resistance therapy is administered. And non-resistance therapy group is also treated with other Korean integrative medicine treatment everyday: acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine.
干预措施: chuna (Other)
Non-resistance therapy
From the 2nd to 5th day of hospitalization, once a day, 4 times of non-resistance therapy is administered. And non-resistance therapy group is also treated with other Korean integrative medicine treatment everyday: acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine.
干预措施: pharmacoacupuncture (Other)
Non-resistance therapy
From the 2nd to 5th day of hospitalization, once a day, 4 times of non-resistance therapy is administered. And non-resistance therapy group is also treated with other Korean integrative medicine treatment everyday: acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine.
干预措施: Korean herbal medicine (Drug)
Oriental medicine integrated treatment
The control group is received Korean integrative medicine treatment everyday; acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine.
干预措施: acupuncture (Other)
Oriental medicine integrated treatment
The control group is received Korean integrative medicine treatment everyday; acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine.
干预措施: chuna (Other)
Oriental medicine integrated treatment
The control group is received Korean integrative medicine treatment everyday; acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine.
干预措施: pharmacoacupuncture (Other)
Oriental medicine integrated treatment
The control group is received Korean integrative medicine treatment everyday; acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine.
干预措施: Korean herbal medicine (Drug)
结局指标
主要结局
Numeric Rating Scale(NRS) of neck pain
时间窗: Change from baseline NRS at 5 days
The extent of acute neck 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 neck 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
- Visual Analogue Scale (VAS) of neck pain(baseline(day2), day3, day4, day5, day of Discharge(up to 14days)
- Range of movement (ROM) of left rotation(baseline(day2), day3, day4, day5, day of Discharge(up to 14days))
- Range of movement (ROM) of right rotation(baseline(day2), day3, day4, day5, day of Discharge(up to 14days))
- Numeric Rating Scale(NRS) of neck pain(baseline(day2), day3, day4, day5, day of Discharge(up to 14days), week 12)
- Visual Analogue Scale (VAS) of arm pain(baseline(day2), day3, day4, day5, day of Discharge(up to 14days))
- Range of movement (ROM) of flexion(baseline(day2), day3, day4, day5, day of Discharge(up to 14days))
- Range of movement (ROM) of extension(baseline(day2), day3, day4, day5, day of Discharge(up to 14days))
- Range of movement (ROM) of right lateral flexion(baseline(day2), day3, day4, day5, day of Discharge(up to 14days))
- Neck Disability Index (NDI)(baseline(day2), day5, day of Discharge(up to 14days), week 12)
- Patient Global Impression of Change (PGIC)(day5, day of Discharge(up to 14days), week 12)
- Drug Consumption(baseline(day2), day3, day4, day5, day of Discharge(up to 14days), week 12)
- Adverse events(baseline(day2), day3, day4, day5, day of Discharge(up to 14days), week 12)
- Range of movement (ROM) of left lateral flexion(baseline(day2), day3, day4, day5, day of Discharge(up to 14days))
- Korean version of The Posttraumatic Stress Disorder Checklist for DSM-5(PCL-5-K)(baseline(day 2), day5, day of Discharge(up to 14days), week 12)
- Numeric Rating Scale(NRS) of arm pain(baseline(day2), day3, day4, day5, day of Discharge(up to 14days), week 12)
- 12-item Short-Form Health Survey (SF-12)(baseline(day 2), day5, day of Discharge(up to 14days), week 12)
- Credibility and Expectancy(baseline(day 2))
研究者
In-Hyuk Ha, KMD
Director
Jaseng Medical Foundation