Effectiveness and safety of Tongluo Qutong Ointment in treating pain caused by cervical spondylotic radiculopathy (blood stasis and stagnation, cold dampness blocking collateral syndrome)

Phase 4

• Conditions: Cervical spondylotic radiculopathy

• Registration Number: ITMCTR2100005229
• Lead Sponsor: The Second People's Hospital of Gansu Province

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Onset time and disappearance time of pain;Brachial plexus traction test / foraminal compression test at each time point;Proportion of patients who quit early due to poor efficacy or adverse events;The decreased score and rate of cervical disability index (NDI) at each time point;Numbness disappearance rate and time;Reduction rate of the VAS score of pain decreased compared with baseline;The decreased VAS score of pain compared with baseline;The ratio of pain VAS score =< 1 at each time point;