NCT07839260

Brief Summary

This study evaluated changes in brain-muscle coordination in patients with ankle sprain after one session of microneedle-knife therapy. Microneedle-knife therapy is a minimally invasive treatment applied to soft tissues related to the lower leg and foot. Eleven participants completed electroencephalography (EEG) and electromyography (EMG) recordings before and after treatment. During each recording, participants performed ankle dorsiflexion, eversion, and inversion or isometric contraction tasks. The primary analysis examined corticomuscular coupling, which reflects coordination between activity in motor-related brain regions and lower-limb muscles, particularly within the beta frequency band of 15 to 30 Hz.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 24, 2026

Completed
Last Updated

September 24, 2026

Status Verified

September 1, 2026

Enrollment Period

Same day

First QC Date

September 19, 2026

Last Update Submit

September 19, 2026

Conditions

Keywords

Microneedle-Knife TherapyAcupotomyCorticomuscular CouplingCorticomuscular CoherenceElectroencephalographyElectromyographyEEG-EMGcaCOHBeta BandAnkle Motor Control

Outcome Measures

Primary Outcomes (1)

  • Change From Pre-Treatment in Mean Beta-Band Corticomuscular Coupling Measured by caCOH

    Mean caCOH within the beta frequency band of 15 to 30 Hz was calculated from synchronized EEG and EMG recordings for each participant during ankle dorsiflexion, eversion, and inversion or isometric contraction tasks. The primary analysis focused on motor-related EEG channels C3 and C4 and task-relevant lower-limb muscles. Change in caCOH was calculated as the post-treatment value minus the pre-treatment value. A positive change indicates increased corticomuscular coupling after treatment.

    Baseline and immediately after the single microneedle-knife therapy session

Study Arms (1)

Microneedle-Knife Therapy

EXPERIMENTAL

One session of microneedle-knife therapy was administered to soft-tissue regions related to the affected lower leg and foot. No other therapeutic intervention was administered as part of the study during the treatment period.

Procedure: Microneedle-Knife Therapy

Interventions

One session of microneedle-knife therapy was administered to soft-tissue regions related to the affected lower leg and foot. No other therapeutic intervention was administered as part of the study during the treatment period.

Microneedle-Knife Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinically diagnosed ankle sprain.
  • Able to perform ankle dorsiflexion, eversion, and inversion or isometric contraction tasks according to the researchers' instructions.
  • Able to complete synchronous EEG and EMG recordings before and after treatment.
  • Willing to participate and able to provide written informed consent.

You may not qualify if:

  • Severe neurological disease, osteoarticular disease, or another condition affecting lower-limb motor control.
  • Severe cognitive impairment, impaired auditory comprehension, or inability to follow the experimental instructions.
  • Recent receipt of another therapeutic intervention that could substantially affect lower-limb motor function.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Dongyang, Zhejiang, 322100, China

Location

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: All participants were assigned to a single intervention arm and received one session of microneedle-knife therapy. Synchronous EEG and EMG recordings were performed before and after the intervention. Each participant served as their own control, and no parallel control group was included.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Chief Physician

Study Record Dates

First Submitted

September 19, 2026

First Posted

September 24, 2026

Study Start

January 1, 2023

Primary Completion

January 1, 2023

Study Completion

June 1, 2026

Last Updated

September 24, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations