Micro-needle-knife Therapy in Releasing the Superficial Fascia for Patients With Acute Ankle Sprain: an Assessor-blinded, Randomised Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute Ankle Sprain
- Sponsor
- Sen-wei Lu
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Visual Analogue Scale (VAS)
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
The goal of this type of randomized controlled trial, employing a blinded evaluator methodology, to verify the clinical efficacy and safety of MNK therapy. This aims to provide a reference for clinical practitioners and AAS patients in their decision-making process.
Participants will randomly allocated into two groups using a random number table method, with forty patients in each group. The experimental group (Group 1) underwent MNK therapy to release the superficial fascia, while the control group (Group 2) received conventional acupuncture treatment.
Investigators
Sen-wei Lu
Prof.
Affiliated Dongyang Hospital of Wenzhou Medical University
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
Outcomes
Primary Outcomes
Visual Analogue Scale (VAS)
Time Frame: up to one mont
The VAS is utilized to assess the degree of pain experienced by the patient. Patients select an appropriate number (0 to 10) based on their perceived pain intensity: 0 indicates no pain and a normal state; 1 to 3 signifies mild pain that is tolerable and does not interfere with daily activities; 4 to 6 represents moderate pain that is noticeable and tolerable but affects daily life and sleep; 7 to 10 indicates severe pain that is intolerable.
Kofoed Ankle Score
Time Frame: up to one mont
This score evaluates the functional recovery of the ankle joint following treatment, focusing on pain, function, and mobility. The total score is out of 100, with 85-100 classified as excellent, 75-85 as good, 70-74 as satisfactory, and below 70 as poor.