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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050354
Enrollment
Unknown
Registered
2021-08-26
Start date
2021-09-01
Completion date
Unknown
Last updated
2022-04-25

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

Conditions

Cervical spondylotic radiculopathy

Interventions

Sponsors

The Second People's Hospital of Gansu Province
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

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

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.

Design outcomes

Primary

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

Countries

China

Contacts

Public ContactXie Xingwen

The Second People's Hospital of Gansu Province

datatcm@126.com+86 15002591615

Outcome results

None listed

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