Shi-style Cervical Manipulations for Nonspecific Neck Pain: a Multi-center, Randomized, Controlled Clinical Trial
2021年10月25日 更新者：Cui xuejun、Shanghai University of Traditional Chinese Medicine
Spinal instability diseases have a high prevalence and great harm.
The research on how to prevent and treat degenerative spinal instability diseases has become a hot spot in the international academic community, and it is also an important research content in the field of "population and health" in my country.
Clinical studies have shown that the "Shi-style manipulations" have outstanding efficacy and high safety in the treatment of degenerative spinal instability diseases.
The study intends to carry out a randomized, traction-controlled study in 5 tertiary hospital test centers, with patients with non-specific neck pain as the research object, using "Shi-style manipulations" and traction as intervention methods, and checking indicators and subjective effects through relevant instruments Indicators, quantitative verification of the mechanical parameters and biological effects of the "Shi-style manipulations", scientific evaluation of the efficacy and safety of the "Shi-style manipulations" in non-specific neck pain diseases.
研究概览
详细说明
Spinal diseases are listed as the second most serious diseases in the world's top ten Diseases released by WHO. With the rapid pace of life, the aging of the population and the increase in chronic strain, the incidence of degenerative spinal instability diseases remains high and medical expenses increase.
From 1999 to 2006, 534 patients with various types of degenerative spine instability diseases (except myelomyelitis) were treated by the project team, and the total effective rate of the "three steps and nine steps" in the treatment of clinical symptoms and signs of degenerative spine instability diseases was 91.76%. Through reviewing 60 cases of nerve root type of randomized controlled trials, 8 weeks after treatment, treatment group 30 cases (the whole neck three-step nine method), total effective rate 93.3%, control group total effective rate was 73.3% (cervical traction) (P < 0.01), the treatment group in improving the neck shoulder pain, upper limb numbness, dizziness, tinnitus, brachial plexus pull test is better than that in control group (P < 0.05), the clinical operation without adverse reaction.
Clinical studies have shown that the "Shi-style manipulations" have outstanding efficacy and high safety in the treatment of degenerative spinal instability diseases. The study intends to carry out a randomized, traction-controlled study in 5 tertiary hospital test centers, with patients with non-specific neck pain as the research object, using "Shi-style manipulations" and traction as intervention methods, and checking indicators and subjective effects through relevant instruments Indicators, quantitative verification of the mechanical parameters and biological effects of the "Shi-style manipulations", scientific evaluation of the efficacy and safety of the "Shi-style manipulations" in non-specific neck pain diseases.
研究类型
介入性
注册 (预期的)
240
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Xuejun Cui, Doctor of Medicine(M.D.)
- 电话号码：86-21-64385700
- 邮箱：13917715524@139.com
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- The diagnosis is non-specific neck pain;
- Male or female between the ages of 18 and 65 (including 18 and 65);
- VAS score ≥30 mm;
- Sign the informed consent voluntarily.
Exclusion Criteria:
- Have received surgical treatment or neck trauma for cervical spondylosis in the past;
- With cervical nerve compression or spinal cord compression symptoms and signs, MRI found spinal compression;
- The vertebral body was shifted, horizontally shifted >3 mm forward, backward or laterally, and the adjacent intervertebral space had an Angle difference of >11°;
- Patients with liver, kidney, hematopoietic system and other serious primary diseases, with a history of opioid analgesics, sedative and hypnotic drugs and alcohol abuse;
- Patients with osteoporosis, spinal tuberculosis, vertebral body malformation, malignant tumors and mental diseases;
- Pregnant women and lactating women;
- Unable to participate in the follow-up (for example, the plan of migration or long-distance relocation within half a year, no communication tools such as mobile phones, etc.), and the patients without the ability to participate in the half-year follow-up cannot read and write Chinese;
- received radio frequency, minimally invasive, ozone, small needle knife, manipulation, traction or closed treatment Within the last two weeks;
- Participating in other clinical trials related to cervical spondylosis.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Traction
6kg to 10kg, 3 times a week, once the other day（except the weekends）,20 minutes, 2 weeks.
|
6kg～10kg，每周3次，隔天一次（周末除外），20分钟，2周。
其他名称：
|
|
实验性的：Shi-style manipulations
Shi-style manipulations is a cervical manipulation for cervical spondylosis.This manipulation is a kind of traditional Chinese massage and it can dredge the meridians.
Patients are treated every day for 30 minutes.
Seven times as one course and totally there are two courses.
3 times a week, once the other day（except the weekends）,30 minutes, 2 weeks.
|
Shi-style cervical manipulation is a spinal manipulation for cervical radiculopathy.It is a kind of traditional chinese massage and can dredge the meridian.Patients are treated every day for 30 minutes.Seven times at one course and totally there are two courses.3
times a week, once the other day（except the weekends）,30 minutes, 2 weeks.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Musculoskeletal ultrasound
大体时间：changes from baseline at 2 weeks
|
Measure the ratio of the muscle thickness of the back of the neck muscles to the strain rate of the back of the neck muscles.Use real-time dual-frame imaging to adjust the area of interest to ensure coverage of trapezius, supraspinatus, infraspinatus, levator scapula, and sternocleidomastoid.
During operation, the probe lightly touches the ultrasonic coupling patch and is perpendicular to the body surface, hold the probe to slightly vibrate up and down, and keep the pressure release index at 3-4.
Collect the elastic image to ensure that the image is clear and stable for 3-4 seconds.
Observe the elastic image and outline the reference area and the area of interest.
Calculate the SR values of the reference area and the area of interest with the software that comes with the ultrasound system.
Measure 3 times and take the average value.
|
changes from baseline at 2 weeks
|
|
Visual Analogue scale，(VAS)
大体时间：changes from baseline at 2 weeks
|
The visual analog scale is used to measure the patient's current pain level.This scoring ruler has a scale in centimeters on one side, and the smallest scale is millimeters; on the other side, the two ends are marked as "painless" and "most painful".
When using, the researcher holds both ends of the visual analog scale with both hands.
The scale faces the researcher and the non-scale faces the patient.
The patient is asked to use the thumb and index finger to move the upper scale of the ruler to the level of pain.Read the scale value corresponding to the red line of the vernier of the visual analog scale and record it in the research medical record.
The value is rounded to a single digit, and the unit is millimeter (mm).
The red line is between the two scales, and the left value is taken.
Such as "53mm".
|
changes from baseline at 2 weeks
|
|
pressure pain threshold
大体时间：changes from baseline at 2 weeks
|
Determine the corresponding acupoints on the subject's neck, use a round probe to find the pain sensitive points, and mark them with a marker to be measured.
There are 10 points in total.In order to fully relax the tested muscles, supine or lateral positions are used in the measurement.
Before measuring, inform the subject of the entire operation process.The measurement was started after he entered the examination room and rested quietly for 5 minutes.
During the measurement, a tester holds a digital dynamometer, touches the instrument probe vertically downwards to the skin, and applies pressure to the test point at a uniform speed when applying force.
When the subject begins to feel pain, immediately remove the test probe and read the data on the instrument at the same time.
After the measurement is completed, press the zero button to perform the next measurement.
The same acupuncture point was tested 3 times with an interval of 30s, and the average value was taken.
|
changes from baseline at 2 weeks
|
|
Musculoskeletal ultrasound
大体时间：changes from baseline at 1 month
|
Measure the ratio of the muscle thickness of the back of the neck muscles to the strain rate of the back of the neck muscles.Use real-time dual-frame imaging to adjust the area of interest to ensure coverage of trapezius, supraspinatus, infraspinatus, levator scapula, and sternocleidomastoid.
During operation, the probe lightly touches the ultrasonic coupling patch and is perpendicular to the body surface, hold the probe to slightly vibrate up and down, and keep the pressure release index at 3-4.
Collect the elastic image to ensure that the image is clear and stable for 3-4 seconds.
Observe the elastic image and outline the reference area and the area of interest.
Calculate the SR values of the reference area and the area of interest with the software that comes with the ultrasound system.
Measure 3 times and take the average value.
|
changes from baseline at 1 month
|
|
Visual Analogue scale，(VAS)
大体时间：changes from baseline at 1 month
|
The visual analog scale is used to measure the patient's current pain level.This scoring ruler has a scale in centimeters on one side, and the smallest scale is millimeters; on the other side, the two ends are marked as "painless" and "most painful".
When using, the researcher holds both ends of the visual analog scale with both hands.
The scale faces the researcher and the non-scale faces the patient.
The patient is asked to use the thumb and index finger to move the upper scale of the ruler to the level of pain.Read the scale value corresponding to the red line of the vernier of the visual analog scale and record it in the research medical record.
The value is rounded to a single digit, and the unit is millimeter (mm).
The red line is between the two scales, and the left value is taken.
Such as "53mm".
|
changes from baseline at 1 month
|
|
pressure pain threshold
大体时间：changes from baseline at 1 month
|
Determine the corresponding acupoints on the subject's neck, use a round probe to find the pain sensitive points, and mark them with a marker to be measured.
There are 10 points in total.In order to fully relax the tested muscles, supine or lateral positions are used in the measurement.
Before measuring, inform the subject of the entire operation process.The measurement was started after he entered the examination room and rested quietly for 5 minutes.
During the measurement, a tester holds a digital dynamometer, touches the instrument probe vertically downwards to the skin, and applies pressure to the test point at a uniform speed when applying force.
When the subject begins to feel pain, immediately remove the test probe and read the data on the instrument at the same time.
After the measurement is completed, press the zero button to perform the next measurement.
The same acupuncture point was tested 3 times with an interval of 30s, and the average value was taken.
|
changes from baseline at 1 month
|
|
Musculoskeletal ultrasound
大体时间：changes from baseline at 3 months
|
Measure the ratio of the muscle thickness of the back of the neck muscles to the strain rate of the back of the neck muscles.Use real-time dual-frame imaging to adjust the area of interest to ensure coverage of trapezius, supraspinatus, infraspinatus, levator scapula, and sternocleidomastoid.
During operation, the probe lightly touches the ultrasonic coupling patch and is perpendicular to the body surface, hold the probe to slightly vibrate up and down, and keep the pressure release index at 3-4.
Collect the elastic image to ensure that the image is clear and stable for 3-4 seconds.
Observe the elastic image and outline the reference area and the area of interest.
Calculate the SR values of the reference area and the area of interest with the software that comes with the ultrasound system.
Measure 3 times and take the average value.
|
changes from baseline at 3 months
|
|
Visual Analogue scale，(VAS)
大体时间：changes from baseline at 3 months
|
The visual analog scale is used to measure the patient's current pain level.This scoring ruler has a scale in centimeters on one side, and the smallest scale is millimeters; on the other side, the two ends are marked as "painless" and "most painful".
When using, the researcher holds both ends of the visual analog scale with both hands.
The scale faces the researcher and the non-scale faces the patient.
The patient is asked to use the thumb and index finger to move the upper scale of the ruler to the level of pain.Read the scale value corresponding to the red line of the vernier of the visual analog scale and record it in the research medical record.
The value is rounded to a single digit, and the unit is millimeter (mm).
The red line is between the two scales, and the left value is taken.
Such as "53mm".
|
changes from baseline at 3 months
|
|
pressure pain threshold
大体时间：changes from baseline at 3 months
|
Determine the corresponding acupoints on the subject's neck, use a round probe to find the pain sensitive points, and mark them with a marker to be measured.
There are 10 points in total.In order to fully relax the tested muscles, supine or lateral positions are used in the measurement.
Before measuring, inform the subject of the entire operation process.The measurement was started after he entered the examination room and rested quietly for 5 minutes.
During the measurement, a tester holds a digital dynamometer, touches the instrument probe vertically downwards to the skin, and applies pressure to the test point at a uniform speed when applying force.
When the subject begins to feel pain, immediately remove the test probe and read the data on the instrument at the same time.
After the measurement is completed, press the zero button to perform the next measurement.
The same acupuncture point was tested 3 times with an interval of 30s, and the average value was taken.
|
changes from baseline at 3 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Neck Disabilitv Index， (NDI)
大体时间：changes from baseline at 2 weeks
|
The Neck Disability Index (NDI) is one of the most frequently used questionnaires in clinical practice.
The questionnaire mainly assesses the patient's pain level, self-care ability, weightlifting, reading, headache level, concentration, work, driving, sleep, and entertainment.
It quantifies the points of all aspects, and the score ranges from 0 points (no disability) to 5 points (completely disabled), the total score ranges from 0 points (no disability) to 50 points (completely disabled), for a total of 50 points.
The lower the total score, the less severe the patient's condition, and vice versa.
|
changes from baseline at 2 weeks
|
|
the MOS item short from health survey，(SF-36)
大体时间：changes from baseline at 2 weeks
|
The SF-36 scale is a universal scale developed by the American Medical Research Group to measure the quality of life, and is universally recognized and widely used in the world.
This scale has a total of 8 dimensions to evaluate health-related quality of life (HRQOL), which is divided into two categories: physical health and mental health, namely physical function (PF), physical function (RP), physical pain (BP), and general health (CH), Activity (VT), Social Function (SF), Emotional Function (RE), Mental Health (MH).
|
changes from baseline at 2 weeks
|
|
Cervical range of motion
大体时间：changes from baseline at 2 weeks
|
Measure the range of cervical spine flexion, extension, lateral flexion, and rotation by using a universal protractor
|
changes from baseline at 2 weeks
|
|
Neck Disabilitv Index， (NDI)
大体时间：changes from baseline at 1 month
|
The Neck Disability Index (NDI) is one of the most frequently used questionnaires in clinical practice.
The questionnaire mainly assesses the patient's pain level, self-care ability, weightlifting, reading, headache level, concentration, work, driving, sleep, and entertainment.
It quantifies the points of all aspects, and the score ranges from 0 points (no disability) to 5 points (completely disabled), the total score ranges from 0 points (no disability) to 50 points (completely disabled), for a total of 50 points.
The lower the total score, the less severe the patient's condition, and vice versa.
|
changes from baseline at 1 month
|
|
the MOS item short from health survey，(SF-36)
大体时间：changes from baseline at 1 month
|
The SF-36 scale is a universal scale developed by the American Medical Research Group to measure the quality of life, and is universally recognized and widely used in the world.
This scale has a total of 8 dimensions to evaluate health-related quality of life (HRQOL), which is divided into two categories: physical health and mental health, namely physical function (PF), physical function (RP), physical pain (BP), and general health (CH), Activity (VT), Social Function (SF), Emotional Function (RE), Mental Health (MH).
|
changes from baseline at 1 month
|
|
Cervical range of motion
大体时间：changes from baseline at 1 month
|
Measure the range of cervical spine flexion, extension, lateral flexion, and rotation by using a universal protractor
|
changes from baseline at 1 month
|
|
Neck Disabilitv Index， (NDI)
大体时间：changes from baseline at 3 months
|
The Neck Disability Index (NDI) is one of the most frequently used questionnaires in clinical practice.
The questionnaire mainly assesses the patient's pain level, self-care ability, weightlifting, reading, headache level, concentration, work, driving, sleep, and entertainment.
It quantifies the points of all aspects, and the score ranges from 0 points (no disability) to 5 points (completely disabled), the total score ranges from 0 points (no disability) to 50 points (completely disabled), for a total of 50 points.
The lower the total score, the less severe the patient's condition, and vice versa.
|
changes from baseline at 3 months
|
|
the MOS item short from health survey，(SF-36)
大体时间：changes from baseline at 3 months
|
The SF-36 scale is a universal scale developed by the American Medical Research Group to measure the quality of life, and is universally recognized and widely used in the world.
This scale has a total of 8 dimensions to evaluate health-related quality of life (HRQOL), which is divided into two categories: physical health and mental health, namely physical function (PF), physical function (RP), physical pain (BP), and general health (CH), Activity (VT), Social Function (SF), Emotional Function (RE), Mental Health (MH).
|
changes from baseline at 3 months
|
|
Cervical range of motion
大体时间：changes from baseline at 3 months
|
Measure the range of cervical spine flexion, extension, lateral flexion, and rotation by using a universal protractor
|
changes from baseline at 3 months
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The doctor of traditional Chinese medicine syndrome
大体时间：changes from baseline at 2 weeks
|
The TCM Syndrome Feature Scale is based on the patient's general symptoms, signs (including tongue and pulse), physical examination, and laboratory examination results to establish an information table, and then use the difference matrix method to perform attribute reduction and case reduction to obtain The lower approximation set and the upper approximation set are used to extract the definite rules and possible rules of TCM diagnosis.
In this way, the subjectivity and one-sidedness of doctors are avoided to a large extent, making TCM syndrome diagnosis and treatment more standardized and scientific
|
changes from baseline at 2 weeks
|
|
The doctor of traditional Chinese medicine syndrome
大体时间：changes from baseline at 1 month
|
The TCM Syndrome Feature Scale is based on the patient's general symptoms, signs (including tongue and pulse), physical examination, and laboratory examination results to establish an information table, and then use the difference matrix method to perform attribute reduction and case reduction to obtain The lower approximation set and the upper approximation set are used to extract the definite rules and possible rules of TCM diagnosis.
In this way, the subjectivity and one-sidedness of doctors are avoided to a large extent, making TCM syndrome diagnosis and treatment more standardized and scientific
|
changes from baseline at 1 month
|
|
The doctor of traditional Chinese medicine syndrome
大体时间：changes from baseline at 3 months
|
The TCM Syndrome Feature Scale is based on the patient's general symptoms, signs (including tongue and pulse), physical examination, and laboratory examination results to establish an information table, and then use the difference matrix method to perform attribute reduction and case reduction to obtain The lower approximation set and the upper approximation set are used to extract the definite rules and possible rules of TCM diagnosis.
In this way, the subjectivity and one-sidedness of doctors are avoided to a large extent, making TCM syndrome diagnosis and treatment more standardized and scientific
|
changes from baseline at 3 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员：Yongjun Wan, Doctor of Medicine(M.D.)、Shanghai University of Traditional Chinese Medicine
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (预期的)
2021年11月1日
初级完成 (预期的)
2022年12月30日
研究完成 (预期的)
2022年12月30日
研究注册日期
首次提交
2021年10月25日
首先提交符合 QC 标准的
2021年10月25日
首次发布 (实际的)
2021年11月5日
研究记录更新
最后更新发布 (实际的)
2021年11月5日
上次提交的符合 QC 标准的更新
2021年10月25日
最后验证
2021年10月1日
更多信息
与本研究相关的术语
其他研究编号
- Nonspecific Neck Pain
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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