Actively Recruiting
Clinical Evaluation of Surrounding Electroacupuncture in the Treatment of Acute Lateral Ankle Sprain
Led by The Third Affiliated hospital of Zhejiang Chinese Medical University · Updated on 2023-12-27
84
Participants Needed
1
Research Sites
77 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial evaluates the effectiveness and safety of electroacupuncture combined with surrounding acupuncture for treating acute lateral ankle sprain (ALAS). Researchers aim to compare this method with sham electroacupuncture and traditional treatment involving ice compress and brake rest. The study also investigates how this therapy affects the nerves, muscles, and ligaments involved, exploring its underlying mechanisms and optimizing treatment parameters like time, frequency, and intensity. Participants will be randomly assigned to one of three groups: electroacupuncture combined with surrounding acupuncture, sham electroacupuncture, or ice compress combined with brake rest. The trial uses a quadruple masking approach to ensure unbiased results. Treatments will be administered over a four-week period, followed by a one-week follow-up. This design allows comparison of the clinical effects and physiological changes among different treatment methods. During the study, participants will undergo assessments including the Kofoed score at baseline, after four weeks of treatment, and after one week of follow-up. Additional measurements include musculoskeletal ultrasound evaluations before and after treatment and ankle joint circumference tracking throughout the study. These evaluations help monitor the treatment's impact and safety. Total participation lasts about five weeks, with careful observation of clinical and biochemical changes.
CONDITIONS
Brief Title
Clinical Evaluation of Surrounding Electroacupuncture in the Treatment of Acute Lateral Ankle Sprain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Meets the diagnostic criteria for a grade I or II injury
- Onset time less than or equal to 48 hours
- Age between 18 and 60 years, any gender
- Skin of the affected ankle joint is intact without breaks or ulcers
You will not qualify if you...
- Presence of ankle fracture
- Grade III injury or complete ligament rupture
- Unable to comply with the treatment program or has keloid or other skin diseases unsuitable for electroacupuncture
- Serious cardiovascular, cerebrovascular, liver, kidney, blood system, or systemic failure
- Connective tissue disease, hemophilia, diabetes, malignant tumors, or bleeding tendency
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive one of three treatments: electroacupuncture combined with surrounding acupuncture, sham electroacupuncture, or ice compress combined with brake rest to treat acute lateral ankle sprain.
Visits at baseline (week 0) and after treatment (week 4)
Duration - 1 week
Participants are assessed one week after treatment completion to monitor recovery and treatment effects.
1 follow-up visit (week 5)
Trial Site Locations
Total: 1 location
1
The Third Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
Q
Qimiao Hu, Phd
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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