NCT06266520

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Sen-wei Lu · Academic / Other
• Sex: All
• Age: 16 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Ankle Sprain

Interventions

Type	Name	Description
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.
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

Timeline

• Start date: 2023-01-01
• Primary completion: 2025-06-01
• Completion: 2025-06-01
• First posted: 2024-02-20
• Last updated: 2024-02-20

Locations

1 site across 1 country: China