Could a needle beat a brace for ankle sprains?
NCT ID NCT07161427
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
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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
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About 62 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2025
An estimate. Start dates often move.
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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