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

Not Applicable

Recruiting

• Conditions: Acute Ankle Sprain

• Registration Number: NCT06266520
• Lead Sponsor: Sen-wei Lu

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Status Verified: 2024-02
• Study First Submitted: 2024-02-06
• Study First Submitted QC: 2024-02-16
• Last Update Submitted: 2024-02-16
• Study First Posted: 2024-02-20
• Last Update Posted: 2024-02-20
• Primary Completion: 2025-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale (VAS)	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	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.

Trial Locations

Locations (1)

The Affiliated Dongyang Hospital of Wenzhou Medical University, Dongyang, Zhejiang, China; 🇨🇳 Dongyang, Zhejiang, China