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A randomized controlled study of Tongluo Qutong Ointment in the treatment of pain in cervical spondylotic radiculopathy

A randomized controlled study of Tongluo Qutong Ointment in the treatment of pain in cervical spondylotic radiculopathy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200006401
Enrollment
Unknown
Registered
2022-07-31
Start date
2022-07-30
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cervical spondylopathy radiculo

Interventions

Experimental group:tong-luo qu-tong ointment
Control group:Diclofenac sodium ointment
tong-luo qu-tongointmentDiclofenac sodium ointment

Sponsors

Gansu Province second People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (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.

Exclusion criteria

Exclusion criteria: (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.

Design outcomes

Primary

MeasureTime frame
VAS score;

Secondary

MeasureTime frame
NDI score;

Countries

China

Contacts

Public ContactXie xingwen

Gansu Province second People's Hospital

748570564@qq.com15002591615

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026