Shi-style Cervical Manipulations for Nonspecific Neck Pain: a Multi-center, Randomized, Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 240
- 主要终点
- Visual Analogue scale，(VAS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Visual Analogue scale，(VAS)
时间窗: 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".
Musculoskeletal ultrasound
时间窗: 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.
pressure pain threshold
时间窗: 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.
次要结局
- Neck Disabilitv Index， (NDI)(changes from baseline at 3 months)
- the MOS item short from health survey，(SF-36)(changes from baseline at 3 months)
- Cervical range of motion(changes from baseline at 3 months)
研究者
Cui xuejun
Clinical Research Base of Traditional Chinese Medicine
Shanghai University of Traditional Chinese Medicine