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

February 16, 2024 updated by: Sen-wei Lu

Micro-needle-knife Therapy in Releasing the Superficial Fascia for Patients With Acute Ankle Sprain: an Assessor-blinded, Randomised Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Dongyang, Zhejiang, China, 322100
        • Recruiting
        • The Affiliated Dongyang Hospital of Wenzhou Medical University, Dongyang, Zhejiang, China
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1 (MNK therapy to release the superficial fascia)
The patient, positioned supine and wearing shorts for full lower limb exposure, undergoes layered palpation by the practitioner at the procedure points, identifying tender nodules and swelling in superficial fascia and muscles, followed by disinfection with an iodophor cotton swab. The practitioner, donning sterile latex gloves, holds the micro-needle-knife between the thumb and index finger of the right hand, inserting it parallel to the body's longitudinal axis, while the left thumb presses and holds the cord-like nodules for parallel incisions, with a maximum insertion depth of 5mm, performing lifting and cutting motions. Depending on the nodule size, 1-3 incisions are made. Post-procedure, any bruising or tissue fluid is expelled by massaging from distal to proximal around the incision. The area is then compressed with dry sterile gauze until bleeding ceases. Treatments are administered every other day, totaling six sessions.
Procedure: MNK therapy to release the superficial fascia
The patient, positioned supine and wearing shorts for full lower limb exposure, undergoes layered palpation by the practitioner at the procedure points, identifying tender nodules and swelling in superficial fascia and muscles, followed by disinfection with an iodophor cotton swab. The practitioner, donning sterile latex gloves, holds the micro-needle-knife between the thumb and index finger of the right hand, inserting it parallel to the body's longitudinal axis, while the left thumb presses and holds the cord-like nodules for parallel incisions, with a maximum insertion depth of 5mm, performing lifting and cutting motions. Depending on the nodule size, 1-3 incisions are made. Post-procedure, any bruising or tissue fluid is expelled by massaging from distal to proximal around the incision. The area is then compressed with dry sterile gauze until bleeding ceases. Treatments are administered every other day, totaling six sessions.
Active Comparator: Group 2 (acupuncture)
Group 2 receives acupuncture treatment, employing needles produced by Suzhou Medical Supplies Factory Co., Ltd., with specifications of 0.30mm*40mm and conforming to standard GB2024-1994. Patients, positioned prone or laterally with exposed lower limbs below the knee, are disinfected with an iodophor cotton swab. Acupuncture points selected include GB34, GB39, BL60, BL40, ST41, KI9, and KI6. The practitioner applies pressure to the points with the left hand and swiftly inserts the needle with the right, using a 0.30mm*40mm disposable sterile acupuncture needle, penetrating the skin about 0.5-0.8 inches. After achieving deqi, the needle is twisted and thrust several times, left in place for 30 minutes. Upon removal, the needle site is compressed with a dry cotton swab until bleeding stops. Treatments occur every other day, totaling six sessions
Procedure: acupuncture
Acupuncture treatment employing needles produced by Suzhou Medical Supplies Factory Co., Ltd., with specifications of 0.30mm*40mm and conforming to standard GB2024-1994. Patients, positioned prone or laterally with exposed lower limbs below the knee, are disinfected with an iodophor cotton swab. Acupuncture points selected include GB34, GB39, BL60, BL40, ST41, KI9, and KI6. The practitioner applies pressure to the points with the left hand and swiftly inserts the needle with the right, using a 0.30mm*40mm disposable sterile acupuncture needle, penetrating the skin about 0.5-0.8 inches. After achieving deqi, the needle is twisted and thrust several times, left in place for 30 minutes. Upon removal, the needle site is compressed with a dry cotton swab until bleeding stops. Treatments occur every other day, totaling six sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to one mont
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.
up to one mont

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sen-wei Lu

Investigators

  • Study Director: Xiao-xiao Ma, Dr., The Affiliated Dongyang Hospital of Wenzhou Medical University, Dongyang, Zhejiang, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

February 6, 2024

First Submitted That Met QC Criteria

February 16, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 16, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DongyangH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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