acute lateral ankle ligament sprains
Conditions
Interventions
Treatment Group:Zhihuang Xiaoyu Zhitong plaster
Sponsors
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Meeting both Traditional Chinese Medicine (TCM) and Western medicine diagnostic criteria; 2.Musculoskeletal ultrasound or MRI indicating grade I or II injury of the anterior talofibular ligament (ATFL); 3.Onset of injury within =2 days; 4.Age between 18 and 65 years (inclusive) regardless of sex; 5.No prior use of medications for acute closed soft tissue injuries; 6.Signed informed consent form and commitment to comply with the study protocol.
Exclusion criteria
Exclusion criteria: 1. Presence of infection at the affected area or open wounds at the injury site; 2. Injuries involving two or more anatomical sites; 3. Pre-existing skin conditions at the injury site such as exudative dermatitis eczema infectious skin diseases burns or trauma; 4. Women who are pregnant breastfeeding or planning to become pregnant; 5. Use of medications with properties of promoting blood circulation reducing swelling and pain or relaxing tendons and activating collaterals within 7 days prior to enrollment; 6. Known allergies or hypersensitivity to the investigational drug; 7. Severe comorbidities involving the cardiovascular cerebrovascular hematologic gastrointestinal respiratory neurologic or endocrine systems; 8. Participation in other clinical trials within the past 3 months; 9. Any other condition deemed unsuitable for study participation by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VAS Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| range of motion (ROM);AOFAS Ankle-Hindfoot Score;Ankle musculoskeletal ultrasound;Foot and Ankle Ability Measure (FAAM);swelling degree;Traditional Chinese Medicine syndrome score; | — |
Countries
China
Contacts
Public ContactRuoyu Yao
Longhua hospital shanghai university of traditional chinese medicine
Outcome results
None listed