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MNK Therapy in Releasing the Superficial Fascia for Patients With AAS: an Assessor-blinded, Randomised Controlled Trial

Launched by SEN-WEI LU · Feb 16, 2024

Trial Information

Current as of July 09, 2025

Recruiting

Keywords

Acute Ankle Sprain Micro Needle Knife Superficial Fascia Randomized Controlled Trial

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a new treatment called MNK therapy for patients suffering from an acute ankle sprain (AAS). Acute ankle sprains happen when the ligaments in the ankle are stretched or torn, often due to a sudden twist or fall. In this trial, participants will be divided into two groups. One group will receive MNK therapy, which aims to relieve tension in the superficial fascia (a layer of tissue under the skin), while the other group will get traditional acupuncture treatment. The goal is to see which method helps patients feel better more quickly.

To participate in this study, individuals need to be between 16 and 55 years old and have experienced an ankle injury within the last week. They should also have symptoms like swelling, pain, and bruising in the affected ankle, but must not have any fractures. Participants will be asked to sign a consent form to show they agree to take part in the study. It's important to note that people with certain medical conditions, those who are pregnant or breastfeeding, or anyone with severe needle anxiety won't be eligible to join. This trial is currently recruiting participants, and it aims to provide valuable information for both patients and healthcare providers on the best treatment options for ankle sprains.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 16 to 55 years old
  • Clear history of trauma within 1 to 7 days
  • Presence of localized swelling, pain, bruising, and limping symptoms in the ankle joint
  • Pain in the ankle joint upon resistance
  • No accompanying fractures
  • Diagnosis of acute ankle injury according to the "Diagnostic and Therapeutic Criteria of Traditional Chinese Medicine"
  • No prior treatment before participating in this therapy
  • Willingness to participate in this study and signing of the informed consent form
  • Exclusion Criteria:
  • Individuals with clear indications for surgery
  • Those suffering from gout, rheumatoid arthritis, joint tuberculosis, joint tumors, etc.
  • Pregnant or breastfeeding women
  • Individuals with serious primary diseases of the cardiovascular, liver, kidney, brain, and hematopoietic systems
  • Those with local skin lesions or skin diseases
  • Individuals with coagulation dysfunction
  • Those with severe fear of needles
  • Individuals unwilling to comply with the treatment regimen

About Sen Wei Lu

Sen-Wei Lu is a dedicated clinical trial sponsor with a strong commitment to advancing medical research and improving patient outcomes. Leveraging extensive expertise in clinical development, Sen-Wei Lu focuses on innovative therapies across various therapeutic areas, ensuring rigorous adherence to regulatory standards and ethical guidelines. The organization prioritizes collaboration with industry partners, healthcare professionals, and regulatory bodies to facilitate the successful execution of clinical trials. Through meticulous planning and execution, Sen-Wei Lu aims to contribute valuable insights to the medical community and enhance the quality of care for patients globally.

Locations

Dongyang, Zhejiang, China

Patients applied

0 patients applied

Trial Officials

Xiao-xiao Ma, Dr.

Study Director

The Affiliated Dongyang Hospital of Wenzhou Medical University, Dongyang, Zhejiang, China

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported