Ankle SprainNCT07839260
Changes in Brain-Muscle Coupling After Microneedle-Knife Therapy for Ankle Sprain
A study testing Microneedle-Knife Therapy in people with Ankle Sprain, run by Affiliated Dongyang Hospital of Wenzhou Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankle Sprain
- What is being tested?
- Microneedle-Knife Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Dongyang Hospital of Wenzhou Medical University, Dongyang, Zhejiang, China
Dongyang, Zhejiang, 322100
About this study
Official title: Changes in Corticomuscular Coupling After Microneedle-Knife Therapy in Patients With Ankle Sprain: An EEG-EMG caCOH Analysis
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.
Read the detailed description
This was a single-group, pre-post interventional study involving participants with ankle sprain. Each participant received one session of microneedle-knife therapy targeting relevant soft-tissue regions of the lower leg and foot. No other therapeutic intervention was administered as part of the study during the treatment period.
Synchronous EEG and EMG recordings were performed before and after microneedle-knife therapy. EEG signals were recorded using a NeuSen W64 wireless EEG acquisition system at a sampling frequency of 1,000 Hz. EMG signals were recorded using a Trigno Wireless EMG System. A common trigger was used to temporally align the EEG and EMG signals.
The motor assessment included three ankle tasks: dorsiflexion, eversion, and inversion or isometric contraction. Participants performed the tasks while seated and began each movement after an instruction from the researcher. Each movement lasted approximately 3 seconds and was repeated at least five times. A 1-minute rest period was provided between tasks to reduce fatigue. The tasks were performed in a fixed order: dorsiflexion, eversion, and inversion or isometric contraction.
EEG signals from frontal, central, and parietal scalp regions were analyzed, with particular attention to the motor-related C3, C4, and Cz channels. EMG signals were recorded from the tibialis anterior, peroneus longus, extensor digitorum longus, medial gastrocnemius, lateral gastrocnemius, and soleus muscles.
For each movement event, the signal segment from 0.5 to 2.0 seconds after the movement instruction was used for analysis. Corticomuscular coupling was assessed using the covariance-based coherence (caCOH) index. The principal analysis focused on mean caCOH within the beta frequency band of 15 to 30 Hz and compared measurements obtained before and after treatment across the three ankle motor tasks.
- Conditions
- Ankle Sprain
- Being tested
- Microneedle-Knife Therapy
- Keywords
- Microneedle-Knife Therapy, Acupotomy, Corticomuscular Coupling, Corticomuscular Coherence, Electroencephalography, Electromyography, EEG-EMG, caCOH, Beta Band, Ankle Motor Control
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microneedle-Knife TherapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Microneedle-Knife Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and immediately after the single microneedle-knife therapy session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start1 Jan 2023
- Primary completion1 Jan 2023
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle SprainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Affiliated Dongyang Hospital of Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Hangzhou Dianzi University
- Responsible party
- Principal investigator, Sen-wei Lu, Affiliated Dongyang Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07839260
- Sponsor's protocol ID
- LSW20260914
- Status last verified
- Sep 2026
- First submitted
- 19 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Corticomuscular Coupling After Microneedle-Knife Therapy in Patients With Ankle Sprain: An EEG-EMG caCOH Analysis
- ClinicalTrials.gov ID
- NCT07839260
- Acronym / sponsor ID
- LSW20260914
- Conditions
- Ankle Sprain
- Keywords
- Microneedle-Knife Therapy, Acupotomy, Corticomuscular Coupling, Corticomuscular Coherence, Electroencephalography, Electromyography, EEG-EMG, caCOH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Affiliated Dongyang Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Collaborators
- Hangzhou Dianzi University
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 24 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This was a single-group, pre-post interventional study involving participants with ankle sprain. Each participant received one session of microneedle-knife therapy targeting relevant soft-tissue regions of the lower leg and foot. No other therapeutic intervention was administered as part of the study during the treatment period.
Synchronous EEG and EMG recordings were performed before and after microneedle-knife therapy. EEG signals were recorded using a NeuSen W64 wireless EEG acquisition system at a sampling frequency of 1,000 Hz. EMG signals were recorded using a Trigno Wireless EMG System. A common trigger was used to temporally align the EEG and EMG signals.
The motor assessment included three ankle tasks: dorsiflexion, eversion, and inversion or isometric contraction. Participants performed the tasks while seated and began each movement after an instruction from the researcher. Each movement lasted approximately 3 seconds and was repeated at least five times. A 1-minute rest period was provided between tasks to reduce fatigue. The tasks were performed in a fixed order: dorsiflexion, eversion, and inversion or isometric contraction.
EEG signals from frontal, central, and parietal scalp regions were analyzed, with particular attention to the motor-related C3, C4, and Cz channels. EMG signals were recorded from the tibialis anterior, peroneus longus, extensor digitorum longus, medial gastrocnemius, lateral gastrocnemius, and soleus muscles.
For each movement event, the signal segment from 0.5 to 2.0 seconds after the movement instruction was used for analysis. Corticomuscular coupling was assessed using the covariance-based coherence (caCOH) index. The principal analysis focused on mean caCOH within the beta frequency band of 15 to 30 Hz and compared measurements obtained before and after treatment across the three ankle motor tasks.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Microneedle-Knife Therapy | Experimental | Procedure: Microneedle-Knife TherapyOne 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microneedle-Knife TherapyOne 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 or surgery | Microneedle-Knife Therapy |
Primary outcome
Change From Pre-Treatment in Mean Beta-Band Corticomuscular Coupling Measured by caCOH
Time frame: Baseline and immediately after the single microneedle-knife therapy session
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microneedle-Knife Therapy in people with Ankle Sprain, run by Affiliated Dongyang Hospital of Wenzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Pre-Treatment in Mean Beta-Band Corticomuscular Coupling Measured by caCOH (time frame: Baseline and immediately after the single microneedle-knife therapy session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.