ITMCTR2100005229尚未招募4 期
Effectiveness and safety of Tongluo Qutong Ointment in treating pain caused by cervical spondylotic radiculopathy (blood stasis and stagnation, cold dampness blocking collateral syndrome)
The Second People's Hospital of Gansu Province0 个研究点开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 18 至 65（—）
- 性别
- All
入选标准
- •1. It conforms to the western medical diagnostic criteria of cervical spondylotic radiculopathy, and the syndrome differentiation is blood stasis and stagnation, cold dampness collateral obstruction;
- •2. The main clinical manifestations were neck and/or shoulder and back pain, and the visual analogue scale/score of single site pain was >= 4 points;
- •3. The medical history of cervical spondylosis should not exceed 5 years, and the onset of cervical spondylosis should not exceed 1 week;
- •4. Aged 18 to 65 years, male or female;
- •5. Junior high school education or above, with more than 1 year of experience in using smart phones;
- •6. The subjects give informed consents and sign relevant documents.
排除标准
- •1. Patients with cervical spondylosis with cervical type, myelopathy, vertebral artery type and sympathetic nerve type as the main symptoms;
- •2. Suffering from other diseases mainly characterized by upper limb pain, such as neck sprain, thoracic outlet syndrome, tennis elbow, carpal tunnel syndrome, periarthritis of shoulder, rheumatic myofibrositis, biceps longhead tenosynovitis, etc;
- •3. Patients who had received systematic treatment for cervical spondylosis within 1 week, or who were using analgesics, non-steroidal anti-inflammatory drugs, antidepressants or quinolones before enrollment;
- •4. People who have received neck surgery;Cervical fracture, congenital deformity of cervical vertebra, cervical spinal osseous stenosis, periradiculitis;Patients complicated with diseases such as tumor or tuberculosis;
- •5. The liver function (ALT/AST/ TBIL) exceeds 1.5 times the upper limit of normal value, and the renal function (CR) exceeds the upper limit of normal value;
- •6. Patients with severe primary cardiovascular disease, liver disease, renal disease, hematologic disease, lung disease or any serious disease affecting their survival;
- •7. Patients with cervical spondylosis suitable for surgery (including:(1) The non-surgical treatment of the regular system for more than 3-6 months is ineffective or the non-surgical treatment is effective but the symptoms are repeated and serious, affecting the normal life or work;(2) Progressive atrophy of the innervated muscles due to radiculopathy;(3) Patients with obvious nerve root prickling symptoms, acute acute pain, seriously affecting sleep and normal life), or patients who plan to undergo surgical treatment;
- •8. Neck damage or skin abnormalities (such as rash and eczema), allergic skin;
- •9. Women who are lactating, in pregnancy or preparing to become pregnant within half a year;
- •10. People with a history of allergy to drug patch substrates, drugs, or allergic constitution (people allergic to more than 2 types of substances).Asthma, urticaria or allergic reactions after previous use of aspirin or other non-steroidal anti-inflammatory drugs;
- •11. Those who have participated in other clinical trials within 3 months;
- •12. People with conditions deemed inappropriate by the investigator, such as a history of long-term alcohol consumption.
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