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Could a needle beat a brace for ankle sprains?

NCT ID NCT07161427

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests a new type of acupuncture called Fu's subcutaneous needling against the usual treatment of wearing a brace and doing exercises for people with recent ankle sprains. The goal is to see which approach better reduces pain, improves ankle function, and prevents the sprain from turning into a long-term problem. Sixty-two participants will receive either the needling or the brace-plus-exercise plan for two weeks, and be followed for six months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Fu's subcutaneous needling (a type of acupuncture)
What this could lead to
If it works, this could offer a new, non-surgical option for faster ankle sprain recovery and help prevent long-term ankle problems.
What could go wrong
This is a small, early-stage trial with only 62 people, so results may not apply to everyone. The treatment is compared to standard care, and it's unclear if it will prove more effective.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 62 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2025

An estimate. Start dates often move.

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients with first-time lateral ankle sprains 2. The patient presents with symptoms of swelling and aching and weakness in the ankle joint. There may be a feeling of friction during joint movement, and the symptoms are aggravated after long - distance walking or on rainy and overcast days. 3. The patient presents with swelling and tenderness in the anteroinferior aspect of the lateral malleolus and the anterolateral aspect of the medial malleolus, and has limited mobility during inversion and flexion-extension. 4. Auxiliary examinations: No fracture or dislocation was found in the patient during the examination, and no fracture was detected by X-ray examination. 5. The patient's sprain time is more than 3 weeks and within 6 months. 6. Those who have not received surgical treatment at other medical institutions before coming to our hospital for treatment, can complete the treatment and accept follow - up. 7. The patients' ages range from 18 to 60 years old. 8. The patient voluntarily and is capable of signing the Informed Consent Form. Exclusion Criteria: 1. Those with complete rupture of fractures or soft tissues such as muscles, tendons, and ligaments 2. Patients with severe primary diseases such as heart, liver, kidney, hematopoietic system diseases and mental diseases 3. Patients with tumors or tuberculosis in the ankle joint 4. Patients with rheumatic and rheumatoid arthritis, or gout. 5. Patients with acute inflammatory reactions such as redness, swelling, heat and pain and signs of infection in the ankle joint, or those accompanied by severe osteoarthritis. 6. Patients with abnormal coagulation function or bleeding tendency, such as those with thrombocytopenia and severe diabetes. 7. Patients during pregnancy and lactation 8. Patients with damaged skin at the necessary needle insertion sites.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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