|
研究疾病：
|
职业性颈椎病睡眠障碍
|
研究疾病代码：
|
|
|
Target disease：
|
Occupational cervical insomnia
|
Target disease code：
|
|
研究类型：
Study type：
|
干预性研究
Interventional study
|
研究设计：
Study design：
|
随机平行对照
randomized controlled trial(parallel group design)
|
|
研究所处阶段：
Study phase：
|
探索性研究/预试验
Pilot clinical trial
|
|
研究目的：
|
职业性颈椎病是我国当前广义职业病范畴中较为常见的病种。现行《职业病分类和目录》尚未将颈椎病列入法定职业病，而健康中国行动推进委员会办公室于2019年7月30日召开《健康中国行动（2019-2030年）》发布会，已明确将其列为劳动者个人应当预防的疾病[1]。颈椎病引起的疼痛、交感神经兴奋、椎动脉供血不足等因素均可导致睡眠障碍[2]，长期失眠会严重危害劳动者身心健康。本研究拟采用耳穴定向磁珠疗法治疗职业性颈源性失眠，观察其临床疗效。
磁疗的基本原理在于磁力线经由磁场透入组织深处，调整生物高分子磁矩取向，改变膜系统通透性，进而影响组织细胞生理、生化过程，达到防治疾病之目的[3]。动物实验表明：正常培养条件下，永磁磁场对鼠皮质神经元细胞有促进生长作用，且永磁磁源对细胞结构无显著影响；缺氧培养条件下，永磁磁场内皮质神经元细胞溶解率显著低于无磁场对照组，残留细胞结构致密完整，空泡较少，线粒体体积较大，说明永磁磁源对神经元细胞膜起到保护作用，对细胞凋亡有一定阻止作用[4]。但永磁磁疗安全有效的前提是保证磁力的定向集中，如散乱充磁，穴区磁场或为N极，或为S极，或两极间任一处，极易发生干扰，使穴区磁能强度强弱不一，影响疗效稳定性。相关研究[5]指出，球形磁源的磁感强度与磁场能量密度在磁源内部均匀一致，在磁源外部（穴区组织）则随着远离磁源而不断下降，其中磁极轴向衰减趋势慢于其它径向，磁源内部磁力线为平行直线，外部为一组曲线，围绕磁极轴向的球面附近磁力线曲率较大且较其它径向分布更为密集，磁源内部的磁感强度等值线为一组近似椭圆，近磁源处（贴穴点）的椭圆长短轴接近，远磁源处（穴区深部）的椭圆长短轴相差较大，长轴即两极点连线所在轴向。由此可以推论，耳穴磁珠疗法采用有明确磁极可循的定向永磁体，将磁极线对准穴位施术，可保持相当水平的磁感强度及密度并使磁感带向穴区纵深延展，从而充分利用磁能，发挥穴位磁疗的优势。
目前以耳穴贴压为主干预失眠的文献，多设置苯二氮卓类药物对照组，或观察组在对照措施基础上加用耳穴，难以兼顾盲法。且验证经穴磁疗法的疗效，还须将穴位针刺、贴敷效应与磁场刺激的作用区分开来，部分观察耳穴磁珠疗法的研究设置胶布贴压或王不留行籽贴压对照，虽能区别磁疗和单纯穴位刺激，亦仅对患者设盲，疗效数据采集和报告的偏倚性较大。本研究拟采用散乱充磁磁珠和伪磁珠对比定向充磁磁珠，实现对操作者、患者、疗效评价者同时设盲，纠正偏倚，客观评价疗效。
参考文献：
[1] 孔令晗.“颈椎病或将列入职业病范畴”引发热议[N].北京青年报, 2019-08-01 (10).
[2] 粟胜勇,符文彬,樊凌.颈源性失眠的发病机制及针灸治疗进展 [J].广西中医药大学学报,2013,16(4):69-71.
[3] 吴闽枫.磁疗的治疗技术和方法[J].药物与人,2014,27(7):310.
[4] 张皓楠,王益民,孟庆楠,等.在缺氧条件下永磁磁场对胎鼠皮质神经元细胞生长、凋亡以及形态的影响[J].中国医学物理学杂志,2013,30(6):4580-4584.
[5] 王益民,张皓楠,王蕴华,等.磁疗用球形永磁磁源空间磁场有限元数值计算方法[J].中国医学物理学杂志,2012,29(1):3177-3180.
|
|
Objectives of Study：
|
According to the current broad category of occupational diseases in China, occupational cervical spondylosis is a common disease. The current classification and catalogue of occupational diseases has not listed cervical spondylosis as a legal occupational disease. However, the office of Health China Action Promotion Committee held a press conference on Health China Action (2019-2030)” on July 30, 2019, which has clearly listed it as a disease that should be prevented by individual workers. Pain，sympathetic excitation, and insufficient blood supply of vertebral artery caused by cervical spondylosis, can lead to sleep disorders. Long term insomnia will seriously harm the physical and mental health of workers. In this study, auricular directional magnetic beads will be used to treat occupational cervical insomnia, and clinical effect will be observed.
The fundamental of magnetotherapy is that the magnetic lines penetrates into the deep tissue through the magnetic field, adjusts the magnetic moment orientation of biopolymer, changes the permeability of membrane system, and then affects the physiological and biochemical processes of histocyte, so as to achieve the purpose of disease prevention and treatment. The results of animal experiments showed that: under normal culture conditions, permanent magnetic field can promote the growth of rat cortical neurons, and permanent magnetic source has no significant effect on cell structure; under the condition of anoxic culture, the dissolution rate of cortical neurons in the permanent magnetic field was significantly lower than that in the control group without the magnetic field, and the remaining cells were compact and complete, with fewer vacuoles and larger mitochondria, indicating that the permanent magnetic source had a protective effect on the membrane of neurons and a certain role in preventing apoptosis. However, the premise of safe and effective permanent magnetic therapy is to ensure the directional concentration of magnetic force, such as scattered magnetization, the magnetic field in acupoint area is either N-pole, or S-pole, or any place between the two poles, which is prone to interference, so that the intensity of magnetic energy in acupoint area is different, which affects the stability of curative effect. It is pointed out that the magnetic induction intensity and the magnetic energy density of the spherical magnetic source are uniform in the inner part of the magnetic source, and decrease with the distance from the magnetic source, and the axial attenuation trend of the magnetic pole is slower than other radial directions. The magnetic lines in the magnetic source are parallel lines and a group of curves on the outside. The curvature of the magnetic field lines near the sphere around the pole axis is larger and more dense than other radial distribution. The isoline of magnetic induction intensity in the magnetic source is a group of approximate ellipses. Long and short axis of the ellipse near the magnetic source (sticking to the acupoint) are close to each other, but they are quite different at the far magnetic source (deep part of the acupoint) . The longer axis is the axis where the two poles are connected. Therefore, it can be inferred that if the auricular magnetic bead therapy adopts the directional permanent magnet with definite magnetic pole to follow and applies the magnetic pole line to the acupoint, it can maintain a considerable level of magnetic induction intensity and density, and can make the magnetic induction band extend to the acupoint area in depth, so as to make full use of the magnetic energy and better develop the advantages of acupoint magnetotherapy.
At present, in the literature of treating insomnia mainly by auricular point sticking, benzodiazepines are often used as the control group, or the observation group adds auricular points on the basis of the control measures, which is difficult to give consideration to blinding. In addition, to verify the therapeutic effect of acupoint magnetotherapy, researchers should distinguish the effect of acupoint acupuncture, sticking and magnetic stimulation. Part of the studies on auricular magnetic bead therapy were set up with rubberized fabric or seed of cowherb as control. Although it can distinguish magnetic therapy from pure acupoint stimulation, blinding is only set up to patients. The bias of data collection and report of efficacy is large. In this study, scattered magnetic beads and sham magnetic beads are used to compare the directional magnetic beads, so as to realize blinding for operators, patients and efficacy evaluators at the same time, correct bias and objectively evaluate the efficacy.
|
|
药物成份或治疗方案详述：
|
基础治疗：
对三组患者均予颈椎日常保健指导，如疼痛、眩晕等症状不能自行缓解且难以实现调整工作岗位，则对症给予口服神经妥乐平片、甲钴胺片、颈复康颗粒等药物，或配合物理治疗、外用活血止痛膏等措施。治疗及随访期间允许间断服用小剂量艾司唑仑等助眠药物，持续依赖中等及以上剂量助眠药物者视作无效或脱落病例。
干预方法：
耳穴定向磁疗组（A组）：基础治疗的同时，给予耳穴定向磁疗。参考中华人民共和国国家标准《耳穴名称与部位》（GB/T13734-2008），选取耳穴：肝、心、脾、肾、枕、神门、交感、皮质下。以穴区敏感压痛点为贴压点，施术者以75％乙醇常规消毒，一手固定耳廓，另一手持塑料医用镊子夹取定向磁珠穴贴贴敷于所选耳穴，予适度指压刺激，以患者自觉局部酸、胀、麻、痛、灼热感并能耐受为度。嘱患者或家属分别于每日早、中、晚餐后30min自行按压10～15min，隔2～3日更换1次穴贴，两耳交替，连续治疗30d。
耳穴非定向磁疗组（B组）：选用散乱充磁的磁珠穴贴，基础治疗及耳穴定位、操作、疗程同耳穴定向磁疗组。
耳穴伪磁疗组（C组）：选用无磁性的伪磁珠穴贴，基础治疗及耳穴定位、操作、疗程同耳穴定向/非定向磁疗组。
|
|
Description for medicine or protocol of treatment in detail：
|
Basic Treatment
Three groups of patients will be given usual health guidance of cervical spine. If patient's pain, dizziness and other symptoms can not be relieved by themselves, and it is difficult to adjust the post, the patients shall be given drugs such as Neurotroping tablets, Mecobalamin tablets, Jingfukang granules, etc., or combined with treatment measures such as physical therapy, Huoxuezhitong ointment for external use, etc. During treatment and follow-up period, it is allowed to take small doses of estazolam and other hypnotics intermittently, and those who continue to rely on medium and above doses of hypnotics are regarded as inefficacy or drop-off cases.
Treatment Measure
Auricular directional magnetotherapy group (A group) : At same time of basic treatment, auricular directional magnetotherapy will be given. According to national standard of the People's Republic of China " Name and Location of Auricular Points " (GB/T13734-2008) , following auricular points are selected : jiaogan (AH6a) and shenmen (TF4), zhen (AT3) and pizhixia (AT4), shen (CO10) and gan (CO12), pi (CO13) and xin (CO15). The sensitive tenderness point in acupoint area will be used as sticking point. The operator can use 75% ethanol for routine disinfection, fixed auricle with one hand, and take directional magnetic bead with the other hand holding a plastic tweezer to stick it on the selected auricle point, and give appropriate finger pressure stimulation, so that the patient could consciously feel local acid, swelling, numbness, pain, burning sensation and endure it. Patients will be instructed to press for 10 to 15 minutes by themselves 30 minutes after breakfast, lunch and dinner. Every 2-3 days, acupoint stickings will be replaced once, and the two ears alternately. Continuous treatment for 30 days.
# Auricular non-directional magnetotherapy group (B group) :
Choose the scattered magnetized beads. The basic treatment, auricular point location, operation and course of treatment are the same as group A.
Auricular sham-magnetotherapy group (C group) :
Choose the non-magnetized sham magnetic beads. The basic treatment, auricular point location, operation and course of treatment are the same as group A and B.
|
|
纳入标准：
|
诊断标准
① 参照《安徽省颈椎病分级诊疗指南（2016版）》，所有患者均于院内或院外行颈椎X-ray、CT、MRI、TCD等检查，结合临床表现确诊为“颈椎病”或“颈椎退行性改变”；
② 参照2016年版《失眠症中医临床实践指南(WHO/WPO)》和2016版《中医内科病证诊断疗效标准》（ZY/T001.1-94）中关于失眠（不寐）的诊断依据；
③ 参照《中国精神障碍分类与诊断标准3版》（Chinese Classification of Mental Disorders-3, CCMD-3）有关失眠症状诊断标准：患者以失眠为主，继发难以入睡、睡眠浅、易醒、多梦、早醒、醒后不易再睡、醒后不适感、日间疲乏困倦，常伴焦虑、烦躁、汗出等症状，导致精神活动效率下降，妨碍社会功能，病程标准为每周至少发生3次，且至少持续1月，并排除器质性、精神障碍疾病导致的继发性失眠。
④ 伴头痛、眩晕、心悸、胸闷等症状者，结合心电图、超声、颅脑CT或MRI等检查排除原发性心脑血管疾病。
纳入标准
① 符合上述诊断标准者；
② 年龄25～55岁，性别不限，因工作需要长期伏案、前倾坐位及视频终端作业的企事业单位、民营单位在职人员及自由职业者；
③ 就诊时以（颈源性）失眠作为主诉或主要临床表现之一，不伴或伴有轻中度颈肩背痛、上肢麻木、头晕，胸闷、干呕等症状；
④ 经匹兹堡睡眠质量指数量表（Pittsburgh Sleep Quality Index, PSQI）评分，总分在7分以上，即难以自愈的失眠症患者；
⑤ 患者本人愿意参与试验，家属无异议且协助患者配合治疗，并签署知情同意书；
⑥ 入组前曾接受其它治疗者，予不少于1周洗脱期。
|
|
Inclusion criteria
|
Diagnostic Criteria
According to Guide of Grading Diagnosis and Treatment of Cervical Spondylosis in Anhui Province (2016 Edition), all patients will be examined with X-ray, CT, MRI and TCD of cervical spine in or out of the hospital, and diagnosed as "cervical spondylosis" or "cervical degenerative change" in combination with clinical manifestations.
Refer to the diagnosis basis of insomnia in Clinical Practice Guide of Insomnia in Traditional Chinese Medicine (WHO / WPO, 2016 Edition) and Diagnostic & Efficacy Standard of Medical Diseases in Traditional Chinese Medicine (ZY/T001.1-94, 2016 Edition) .
Refer to the diagnosis basis of insomnia in Chinese Classification of Mental Disorders-3 (CCMD-3): Insomnia is the main symptom of the patients, secondary to difficulty in falling asleep and light sleep, easy to wake up and dreamy, early wake-up and not easy to sleep again after wake-up, discomfort after wake-up and daytime fatigue, often accompanied by anxiety, fidgety, and sweating, resulting in the decline of the efficiency of mental activities, hindering social functions. The course standard is at least 3 times a week and lasts at least 1 month, and secondary insomnia caused by organic and mental disorders is excluded.
Patients with headache, dizziness, palpitation and chest distress, shoud be combined with ECG, B ultrasound, brain CT or MRI examination to eliminate the primary cardiovascular and cerebrovascular diseases.
Inclusion Criteria
1. Those who meet diagnostic criteria above.
2. Employees and freelancers aged 25-55 years old, regardless of gender, who need long-term bend over desk, forward leaning seat and video terminal operation.
3. One of the main clinical manifestations was insomnia, without or only with mild to moderate neck shoulder backache, numbness of upper limbs, dizziness, chest distress, retching, etc..
4. According to the Pittsburgh Sleep Quality Index (PSQI), the total score is more than 7, that is, insomnia patients who are difficult to self-healing.
5. The patient is willing to participate in the trial, the family members have no objection and assist the patient to cooperate with the treatment, and sign the informed consent.
6. Those who had received other treatment before admission to the group were given a elution period of no less than one week.
|
|
排除标准：
|
① 因过度使用电脑、电视、智能手机、iPad等致坐姿、卧姿不良而出现相关症状的未成年人与中老年非在职人员；
② 脊髓型颈椎病、颈部外伤及手术史、脊椎先天异常、神经功能缺损、系统性骨关节病患者；
③ 各型颈椎病伴随症状如疼痛、肢麻、眩晕等程度较重，须作为主要施治方向，失眠为次要症状者（如上述症状经治缓解，失眠症仍未减轻者，可重新纳入）；
④ 因颈动脉/椎基底动脉系统供血不足导致缺血性脑血管病（含TIA）或合并心脏病、高血压、糖尿病、甲亢、血液/肿瘤等其他系统疾病而影响睡眠者；
⑤ 合并精神疾病者，或近期面临个人、家庭、社会重大负性刺激者；
⑥ 耳廓畸形，或穴区皮肤有湿疹、疱疹、创伤、冻伤、脓肿、破溃等情况；
⑦ 对磁性及金属材料过敏者，或对贴压刺激不耐受者；
⑧ 妊娠期、哺乳期女性患者。
|
|
Exclusion criteria：
|
1. The underage and the middle-aged and old people who have the related symptoms due to the overuse of computers, TVs, smartphones, iPads and other causes of poor sitting and lying posture.
2. Patients with cervical spondylotic myelopathy, cervical trauma and operation history, congenital abnormality of spine, nerve function defect and systemic osteoarthropathy.
3. Each type of cervical spondylosis is accompanied by severe symptoms such as pain, limb numbness and dizziness, which should be treated as the main treatment direction, and insomnia as the secondary symptoms. (If above symptoms are relieved after treatment and insomnia is not relieved, they can be included again.)
4. Patients who suffer from ischemic cerebrovascular disease (including TIA) due to insufficient blood supply of carotid / vertebrobasilar system, or other systemic diseases such as heart disease, hypertension, diabetes, hyperthyroidism, hematopathy, tumor and so on, thus affecting sleep.
5. Patients with mental illness, or those who are confronted with personal, family and social negative stimulation recently.
6. Auricle deformity, or eczema, herpes, trauma, frostbite, abscess and ulceration in skin of acupoint area.
7. Those who are allergic to magnetic and metal materials, or intolerant to sticking stimulation.
8. Pregnant and lactating women.
|
|
研究实施时间：
Study execute time：
|
从From
2019-12-01
至To
2022-11-30
|
征募观察对象时间：
Recruiting time：
|
从From
2019-12-01
至To
2022-11-30
|
