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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
240
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.
6kg to 10kg, 3 times a week, once the other day（except the weekends）,20 minutes, 2 weeks.
Musculoskeletal ultrasound
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.
Time frame: changes from baseline at 2 weeks
Visual Analogue scale，(VAS)
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".
Time frame: changes from baseline at 2 weeks
pressure pain threshold
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.
Time frame: changes from baseline at 2 weeks
Musculoskeletal ultrasound
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.
Time frame: changes from baseline at 1 month
Visual Analogue scale，(VAS)
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".
Time frame: changes from baseline at 1 month
pressure pain threshold
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.
Time frame: changes from baseline at 1 month
Musculoskeletal ultrasound
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.
Time frame: changes from baseline at 3 months
Visual Analogue scale，(VAS)
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".
Time frame: changes from baseline at 3 months
pressure pain threshold
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.
Time frame: changes from baseline at 3 months
Neck Disabilitv Index， (NDI)
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.
Time frame: changes from baseline at 2 weeks
the MOS item short from health survey，(SF-36)
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).
Time frame: changes from baseline at 2 weeks
Cervical range of motion
Measure the range of cervical spine flexion, extension, lateral flexion, and rotation by using a universal protractor
Time frame: changes from baseline at 2 weeks
Neck Disabilitv Index， (NDI)
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.
Time frame: changes from baseline at 1 month
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the MOS item short from health survey，(SF-36)
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).
Time frame: changes from baseline at 1 month
Cervical range of motion
Measure the range of cervical spine flexion, extension, lateral flexion, and rotation by using a universal protractor
Time frame: changes from baseline at 1 month
Neck Disabilitv Index， (NDI)
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.
Time frame: changes from baseline at 3 months
the MOS item short from health survey，(SF-36)
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).
Time frame: changes from baseline at 3 months
Cervical range of motion
Measure the range of cervical spine flexion, extension, lateral flexion, and rotation by using a universal protractor
Time frame: changes from baseline at 3 months