A randomized controlled study of Tongluo Qutong Ointment in the treatment of pain in cervical spondylotic radiculopathy
- Conditions
- cervical spondylopathy radiculo
- Registration Number
- ITMCTR2200006401
- Lead Sponsor
- Gansu Province second People's Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
(1) It conforms to the western diagnostic criteria of radicular cervical spondylosis, and the syndrome differentiation is stasis of blood and cold dampness blocking collaterals;
(2) the main clinical manifestation was neck and/or shoulder and back pain, and the VAS score of single site pain was =4;
(3) The history of cervical spondylosis was no more than 5 years, and the onset of cervical spondylosis was no more than 1 week;
(4) Aged 18-65, male or female;
(5) Junior high school education or above, with more than one year of experience in using smart phones;
(6) Subject shall give informed consent and sign relevant documents.
(1) Patients with cervical spondylosis with cervical type, myeloid type, vertebral artery type and sympathetic type as the main symptoms; Previous X - ray /CT/MRI examination showed that the history of cervical spondylosis > 5 years;
(2) patients with other upper limb pain disorders, such as neck sprain, thoracic outlet syndrome, elbow net, carpal tunnel syndrome, periarthritis of shoulder, rheumatic myofibrositis, biceps tenosynovitis, etc.;
(3) patients who had received systematic treatment of cervical spondylosis within 1 week, or were using analgesics, non-steroidal anti-inflammatory drugs, antidepressants or quinolones antibacterial agents before enrollment
(4) those who have received neck surgery; Cervical vertebra fracture, cervical vertebra congenital malformation, cervical canal bony stenosis, periradiculopathy; Complicated with tumor, tuberculosis and other diseases;
(5) Liver function (ALT/AST/TBil) exceeded 1.5 times the upper limit of normal value, and renal function Cr exceeded the upper limit of positive normal value;
(6) patients with serious primary cardiovascular disease, liver disease, kidney disease, hematological disease, lung disease or serious diseases affecting their survival;
(7) patients with cervical spondylosis suitable for surgery (including: 1. Non-surgical treatment of regular system is invalid for more than 3-6 months or non-surgical treatment is effective but recurrent and severe symptoms, affecting normal life or workers; 2. 2. Progressive atrophy of the innervated muscles due to radiculopathy; 3. Patients with obvious symptoms of nerve root tingling, acute and severe pain, seriously affecting sleep and normal life), or those who plan to receive surgical treatment;
(8) Neck damage or skin abnormalities (such as rash, eczema, etc.), allergic skin;
(9) women who are breast-feeding, pregnant or planning pregnancy within six months;
(10) People who have a history of drug adhesion substrate, drug allergy, or allergic constitution (allergic to more than 2 types of substances). Asthma, urticaria or hypersensitization induced by previous use of aspirin or other nsaids;
(11) Those who have participated in other clinical trials within 3 months after consultation;
(12) Those with conditions considered unsuitable for the study by the researcher, such as a long history of alcohol consumption.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method VAS score;
- Secondary Outcome Measures
Name Time Method DI score;