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

NCT ID: NCT06266520

Last Updated: 2024-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2025-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Ankle Sprain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

MNK therapy to release the superficial fascia

Intervention Type PROCEDURE

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.

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

Group Type ACTIVE_COMPARATOR

acupuncture

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

16 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sen-wei Lu

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sen-wei Lu

Prof.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Xiao-xiao Ma, Dr.

Role: STUDY_DIRECTOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Dongyang, Zhejiang, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sen-wei Lu, Dr.

Role: CONTACT

+8613989441117

Jia-na Liu, Dr.

Role: CONTACT

+8613516846216

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Sen-wei Lu, Dr.

Role: primary

+8613989441117

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DongyangH

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.