PURPOSE

Acute lateral ankle sprain (ALAS) is a prevalent clinical sports injury disease, rapid relief of symptoms and return to normal functional activity are urgent needs of ALAS patients. The aim of this study is to observe the immediate therapeutic effect of acupuncture on ALAS patients in the short term and to evaluate the efficacy at different time points through a multidimensional assessment system, which is expected to provide a simple, rapid, safe and effective therapeutic option for ALAS patients.

PATIENTS AND METHODS

This is a single-center, prospective, randomized clinical trial. About 177 eligible ALAS patients will be randomly assigned in a 1:1:1 ratio to the Group A, Group B and Group C. All three groups of patients will be professionally instructed to move their ankle joints in different directions. Group A will receive real acupuncture treatment and Group B will receive sham acupuncture treatment. Each group will receive one treatment of 10 minutes.

PLANNED OUTCOMES

The primary outcome is the change in pain intensity 10 minutes after treatment compared to before treatment, measured using the visual analog scale (VAS). Secondary outcomes will include pain VAS scores at 0, 1, 3 minutes of treatment; Range of motion (ROM) scores for ankle joint mobility and changes in Infrared Thermography (IRT) of the area of ankle pain at 0, 1, 3, 10 minutes of treatment. Other outcomes include the blinding assessment, the expected treatment effect assessment, and the rescue analgesia rate. The statistical analysis of this trial will be performed using SPSS software.

CONCLUSION

The results of this study may provide evidence-based medical evidence for the treatment of ALAS with acupuncture, and it is expected that the findings of this study will provide a simple, rapid, safe and effective treatment option for patients with ALAS.