研究疾病:
|
脑卒中后上肢痉挛
|
研究疾病代码:
|
|
Target disease:
|
Upper limb spasm after stroke
|
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:
|
初步评价经皮穴位电刺激(TEAS)对脑卒中后上肢痉挛患者运动功能恢复的有效性。
|
Objectives of Study:
|
To evaluate the efficacy of transcutaneous electrical acupoint stimulation (TEAS) in the recovery of motor function in patients with upper limb spasticity after stroke.
|
药物成份或治疗方案详述:
|
本项目为前瞻性随机、假TEAS对照、单盲临床试验,计划入组40例,每组各20例。以脑卒中后上肢痉挛患者作为研究对象,TEAS为干预手段,假TEAS为对照,治疗期为6周,随访4周。分别在治疗前、治疗中期、治疗结束后,随访4周时,针对受试者上肢的运动功能、肌肉痉挛程度、疼痛程度、生活能力等进行有效评估,初步明确TEAS对脑卒中后上肢痉挛运动功能的有效性,为临床治疗新方法提供依据。
|
Description for medicine or protocol of treatment in detail:
|
This project is a prospective randomized, sham TEAS controlled, single-blind clinical trial, with 40 cases planned to be enrolled, 20 cases in each group. Patients with upper limb spasticity after stroke were selected as the subjects, TEAS was used as the intervention method, and sham TEAS was used as the control. The treatment period was 6 weeks, and the follow-up period was 4 weeks.The motor function of upper limbs, the degree of muscle spasm, the degree of pain and the ability of daily living were evaluated before treatment, during treatment and after treatment for 4 weeks, so as to preliminarily clarify the effectiveness of TEAS in the treatment of spastic motor function of upper limbs after stroke and provide a basis for new clinical treatment.
|
纳入标准:
|
1、符合西医诊断标准:参照2018年中华医学会神经病学分会脑血管病学组制定的《中国急性缺血性脑卒中诊治指南》中脑梗死的诊断标准,全部病例均经CT或 MRI确诊;
2、符合中医诊断标准:参照中华中医药学会发布的《中医内科常见病诊疗指南》—中风病(ZYYXH/T22- 2008);
3、发病时间在6个月-12个月;
4、上肢痉挛,20≤FMA-UE≤50;
5、年龄在30到75周岁之间;
6、生命体征平稳,意识清楚,语言交流无明显障碍,认知功能基本正常;
7、患者或者家属签署知情同意。
|
Inclusion criteria
|
1. In line with the diagnostic criteria of Western medicine: referring to the diagnostic criteria of cerebral infarction in the Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke in China formulated by the Cerebrovascular Disease Group of the Neurology Society of the Chinese Medical Association in 2018, all cases were diagnosed by CT or MRI;
2. In line with the diagnostic criteria of traditional Chinese medicine: refer to the Guidelines for Diagnosis and Treatment of Common Diseases in Internal Medicine of Traditional Chinese Medicine-Stroke (ZYYXH/T22-2008) issued by the Chinese Society of Traditional Chinese Medicine;
3. The onset time was 6 months to 12 months;
4. Upper limb spasm, 20 ≤ FMA-UE ≤ 50;
5. Age between 30 and 75 years old;
6. The vital signs are stable, the consciousness is clear, the language communication has no obvious obstacle, and the cognitive function is basically normal;
7. Informed consent signed by the patient or family members.
|
排除标准:
|
1、此次脑卒中发作前有上肢痉挛者;
2、其他神经系统病变所致上肢痉挛者;
3、伴有类风湿、骨折、外伤、关节病变等影响肢体运动功能的其他疾病;
4、有复发死亡高危风险者;
5、合并精神疾患或严重的心、肝、肾等重要脏器功能不全及造血系统、内分泌系统等严重原发疾病患者;
6、有经皮穴位电刺激禁忌症(如电子植入物),或有恐惧心理,根据医生判断容易造成失访者;
7、选穴部位有感染、溃疡、瘢痕患者;
8、合并妊娠或哺乳期妇女;
9、本研究期内应用针灸推拿疗法、康复疗法、电或磁刺激疗法、肌肉松弛剂、注射肉毒素A等治疗方法可能影响本研究疗效判断者。
|
Exclusion criteria:
|
1. Patients with upper limb spasm before the onset of stroke;
2. Upper limb spasm caused by other nervous system diseases;
3. Other diseases that affect the motor function of limbs, such as rheumatoid, fracture, trauma and joint lesions;
4. Those with high risk of recurrence and death;
5. Patients with mental disorders or severe dysfunction of important organs such as heart, liver and kidney, as well as severe primary diseases such as hematopoietic system and endocrine system;
6. There are contraindications to transcutaneous electrical acupoint stimulation (such as electronic implants), or fear, which is easy to cause loss of visitors according to the doctor's judgment;
7. Patients with infection, ulcer and scar at selected acupoints;
8. Women with pregnancy or lactation;
9. During the study period, the application of acupuncture and massage therapy, rehabilitation therapy, electrical or magnetic stimulation therapy, muscle relaxants, botulinum toxin A injection and other treatment methods may affect the judgment of the efficacy of the study.
|
研究实施时间:
Study execute time:
|
从From
2021-12-01
至To
2023-09-01
|
征募观察对象时间:
Recruiting time:
|
从From
2022-03-07
至To
2022-09-16
|