Chronic Ankle InstabilityNCT07161427
Fu's Subcutaneous Needling for Postacute Lateral Ankle Sprain and Prevention of Chronic Ankle Instability
A study testing Fu's Subcutaneous Needling therapy and Ankle joint aids combined with exercise therapy in people with Chronic Ankle Instability and Lateral Ankle Sprain, run by Guangzhou University of Chinese Medicine.
Trial summary
Introduction: Fu's Subcutaneous Needling (FSN) is a new type of acupuncture treatment method based on the subcutaneous tissue sweeping technique, and it has been proven to have a good therapeutic effect on ankle sprain. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Ankle Instability, Lateral Ankle Sprain
- What is being tested?
- Fu's Subcutaneous Needling therapy and Ankle joint aids combined with exercise therapy
- Type of treatment
- Injection or infusion, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with first-time lateral ankle sprains
- 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.
- 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.
- Auxiliary examinations: No fracture or dislocation was found in the patient during the examination, and no fracture was detected by X-ray examination.
- The patient's sprain time is more than 3 weeks and within 6 months.
- 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.
- The patients' ages range from 18 to 60 years old.
- The patient voluntarily and is capable of signing the Informed Consent Form.
Who cannot join
- Those with complete rupture of fractures or soft tissues such as muscles, tendons, and ligaments
- Patients with severe primary diseases such as heart, liver, kidney, hematopoietic system diseases and mental diseases
- Patients with tumors or tuberculosis in the ankle joint
- Patients with rheumatic and rheumatoid arthritis, or gout.
- 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.
- Patients with abnormal coagulation function or bleeding tendency, such as those with thrombocytopenia and severe diabetes.
- Patients during pregnancy and lactation
- Patients with damaged skin at the necessary needle insertion sites.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Biomechanics-based Fu's Subcutaneous Needling Versus Bracing Combined With Resistance Training in the Treatment of Postacute Lateral Ankle Sprain and the Prevention of Chronic Ankle Instability: A Randomized Controlled Trial Protocol
Introduction: Fu's Subcutaneous Needling (FSN) is a new type of acupuncture treatment method based on the subcutaneous tissue sweeping technique, and it has been proven to have a good therapeutic effect on ankle sprain. However, at present, the difference between its curative effect and the ankle joint orthosis and exercise therapy recommended by the Guidelines remains unclear. Therefore, this study aims to explore the improvement effects of FSN on pain relief, joint function improvement, and ankle balance ability by comparing with ankle orthosis combined with exercise therapy. Verify whether it is more helpful in preventing the progression of lateral ankle sprain (LAS) to chronic ankle instability (CAI) and provide evidence-based basis for clinical decision-making.
Methods and analysis: This study is a randomized, parallel - controlled, single - center prospective clinical study. This study will include 60 subjects with postacute lateral ankle sprain and divide them into the FSN group and the combined treatment group. There are 30 cases in each group. The FSN group will be treated with Fu's subcutaneous needling three times a week for a total of two weeks. The Combined treatment group will wear ankle orthotics from 9:00 to 20:00, and complete resistance exercise training every day for a total of two weeks.Patients will be followed up for 6 months after the treatment. The main efficacy index is the change value of the Visual Analog Scale (VAS) compared to the baseline after 2 weeks of treatment. The secondary indicators include active range of motion (ROM) of the ankle joint, Star Excursion Balance Test (SEBT), and the Foot and Ankle Ability Measure (FAAM) to prove the clinical efficacy.
Read more
Ethics and dissemination: This study strictly adheres to the ethical guidelines of the Declaration of Helsinki.This study has passed the review of the Ethics Committee of Guangdong Provincial Hospital of Chinese Medicine. Approval No.: YF 2025 - 158 - 01. All subjects will sign a written informed consent form. The research results will be publicly published in journals indexed by SCI.
Keywords: Fu's subcutaneous needling, Ankle sprain, Postacute lateral ankle sprain, Chronic ankle instability, Functional rehabilitation, Balance, Non-surgical therapy
- Conditions
- Chronic Ankle Instability, Lateral Ankle Sprain
- Being tested
- Fu's Subcutaneous Needling therapy, Ankle joint aids combined with exercise therapy
- Keywords
- Fu's subcutaneous needling, Ankle sprain, Postacute lateral ankle sprain, Chronic ankle instability, Functional rehabilitation, Balance, Non-surgical therapy
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fu's Subcutaneous Needling therapyProcedure or surgery
Participants first assume the supine position. After routine disinfection, the Fu's subcutaneous needle is inserted parallelly into the subcutaneous loose connective tissue around the pathologically taut muscles (such as the tibialis anterior, peroneus longus, gastrocnemius, soleus, peroneus brevis, and extensor digitorum longus, etc.). After the needle is fully inserted, fix the protruding part of the hose holder onto the card slot.To minimize the participants' perception of pain, the doctor uses the index finger and ring finger to perform a smooth, gentle, and fan-shaped swinging motion in an alternating front-to-back manner.The sector angle is approximately 60°. It makes a total of round - trips 45 times within 30 seconds. The rocking motion is accompanied by Reperfusion Approach: A set of procedures consists of 20 times of rocking followed by 10 seconds of reperfusion method. Each target lesioned tense muscle requires 2 - 3 sets of the above - mentioned procedures.
Ankle joint aids combined with exercise therapyBehavioural
Participants in the combination therapy group wore ankle orthoses during their daily activities from 9:00 to 20:00 every day for a total of 2 weeks. To ensure standardization, a unified specification is selected for the ankle joint orthosis: Product number: 100159548, the 195R Super Sports Ankle Brace for Inversion/Eversion Sprains and Ligament Fixation by McDavid from the United States. During the treatment with ankle joint orthosis, complete the resistance training every day.
| Study group | Role | What they receive |
|---|---|---|
| FSN group | Experimental | Participants first assume the supine position. After routine disinfection, the Fu's subcutaneous needle is inserted parallelly into the subcutaneous loose connective tissue around the pathologically taut muscles (such as the tibialis anterior, peroneus longus, gastrocnemius, soleus, peroneus brevis, and extensor digitorum longus, etc.). After the needle is fully inserted, fix the protruding part of the hose holder onto the card slot.To minimize the participants' perception of pain, the doctor uses the index finger and ring finger to perform a smooth, gentle, and fan-shaped swinging motion in an alternating front-to-back manner.The sector angle is approximately 60°. It makes a total of round - trips 45 times within 30 seconds. The rocking motion is accompanied by Reperfusion Approach: A set of procedures consists of 20 times of rocking followed by 10 seconds of reperfusion method. Each target lesioned tense muscle requires 2 - 3 sets of the above - mentioned procedures. Receives: Procedure: Fu's Subcutaneous Needling therapy |
| combined treatment group | Active comparator | Participants in the combination therapy group wore ankle orthoses during their daily activities from 9:00 to 20:00 every day for a total of 2 weeks. During the treatment with ankle joint orthosis, complete the resistance training every day. Receives: Behavioral: Ankle joint aids combined with exercise therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
The scoring range of the Visual Analogue Scale (VAS) is 0 - 100 mm, which is used for objectively quantifying the pain level. The participants were instructed to indicate the severity of their ankle pain by marking a point on a continuous horizontal line segment, with 0 mm representing the least pain and 100 mm representing the most severe pain.
Measured: The evaluators measure the outcomes at the baseline, on day 7, day 14, and during the follow - up period (day 28, day 42, 3 months, and 6 months after the start of treatment).
Secondary outcomes (4)
active range of motion of the ankle joint
Active range of motion (ROM), including plantar flexion, dorsiflexion, inversion and eversion, was measured at the baseline, on the 14th day, and during the follow - up period.
Measured: was measured at the baseline, on the 14th day, and during the follow - up period.
The Star Excursion Balance Test
The Star Excursion Balance Test (SEBT) has sufficient sensitivity and high test-retest reliability in the ankle dynamic balance test.
Measured: at the baseline, on the 7th day, on the 14th day, and during the follow-up period.
The Foot and Ankle Ability Measure
The Foot and Ankle Ability Measure (FAAM) is a self - assessment scale commonly used for the individual physical function in injuries related to the foot and ankle joint, which is completed by patients. It includes two subscales: Foot and Ankle Ability Measure - Activity of Daily Living (FAAM - ADL) and Foot and Ankle Ability Measure - Sports (FAAM - S). FAAM - ADL (84 points): It covers 21 daily activities such as standing, walking, squatting, standing on tiptoe, walking for different durations, and doing housework. FAAM - S (32 points): It includes 8 sports - related activities such as running, jumping take - off, landing after a jump, and starting or ending a run. The score range of both sub - scales is 0 - 100%. A total score ≥ 80% indicates a satisfactory functional level, and < 80% indicates functional limitation.
Measured: at the baseline, on the 14th day, and during the follow - up period.
Cumberland Ankle Instability Tool
CAIT consists of 9 items, with scores ranging from 0 to 30. The lower the score, the worse the ankle stability. The threshold for identifying people with chronic ankle instability is inconsistent in different language versions. A score of less than 24 in the Chinese version of CAIT is diagnosed as chronic ankle instability. It is measured at baseline, 14 th and 6 th month follow-up.
Measured: at the baseline, on the 14th day, and during the follow - up period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Ankle InstabilityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lingjing Chen, Guangzhou University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07161427
- Sponsor's protocol ID
- YF 2025 -158-01
- Status last verified
- Aug 2025
- First submitted
- 30 Aug 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Pierobon A, Raguzzi I, Solino S, Salzberg S, Vuoto T, Gilgado D, Perez Calvo E. Minimal detectable change and reliability of the star excursion balance test in patients with lateral ankle sprain. Physiother Res Int. 2020 Oct;25(4):e1850. doi: 10.1002/pri.1850. Epub 2020 May 26.
PubMed 32458531Goulart Neto AM, Maffulli N, Migliorini F, de Menezes FS, Okubo R. Validation of Foot and Ankle Ability Measure (FAAM) and the Foot and Ankle Outcome Score (FAOS) in individuals with chronic ankle instability: a cross-sectional observational study. J Orthop Surg Res. 2022 Jan 21;17(1):38. doi: 10.1186/s13018-022-02925-9.
PubMed 35062990de Noronha M, Refshauge KM, Herbert RD, Kilbreath SL, Hertel J. Do voluntary strength, proprioception, range of motion, or postural sway predict occurrence of lateral ankle sprain? Br J Sports Med. 2006 Oct;40(10):824-8; discussion 828. doi: 10.1136/bjsm.2006.029645. Epub 2006 Aug 18.
PubMed 16920769Hiller CE, Refshauge KM, Bundy AC, Herbert RD, Kilbreath SL. The Cumberland ankle instability tool: a report of validity and reliability testing. Arch Phys Med Rehabil. 2006 Sep;87(9):1235-41. doi: 10.1016/j.apmr.2006.05.022.
PubMed 16935061Chen L, Zhang Y, Chen C, Chen X, Sun J. Fu's subcutaneous needling versus bracing combined with exercise therapy in the treatment of postacute lateral ankle sprain and the prevention of chronic ankle instability: a randomized controlled trial protocol. J Orthop Surg Res. 2026 Feb 28;21(1):239. doi: 10.1186/s13018-026-06719-1.
PubMed 41764543
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomechanics-based Fu's Subcutaneous Needling Versus Bracing Combined With Resistance Training in the Treatment of Postacute Lateral Ankle Sprain and the Prevention of Chronic Ankle Instability: A Randomized Controlled Trial Protocol
- ClinicalTrials.gov ID
- NCT07161427
- Acronym / sponsor ID
- YF 2025 -158-01
- Conditions
- Chronic Ankle Instability, Lateral Ankle Sprain
- Keywords
- Fu's subcutaneous needling, Ankle sprain, Postacute lateral ankle sprain, Chronic ankle instability, Functional rehabilitation, Balance, Non-surgical therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Guangzhou University of Chinese MedicineUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 8 Sep 2025 (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.
Introduction: Fu's Subcutaneous Needling (FSN) is a new type of acupuncture treatment method based on the subcutaneous tissue sweeping technique, and it has been proven to have a good therapeutic effect on ankle sprain. However, at present, the difference between its curative effect and the ankle joint orthosis and exercise therapy recommended by the Guidelines remains unclear. Therefore, this study aims to explore the improvement effects of FSN on pain relief, joint function improvement, and ankle balance ability by comparing with ankle orthosis combined with exercise therapy. Verify whether it is more helpful in preventing the progression of lateral ankle sprain (LAS) to chronic ankle instability (CAI) and provide evidence-based basis for clinical decision-making.
Methods and analysis: This study is a randomized, parallel - controlled, single - center prospective clinical study. This study will include 60 subjects with postacute lateral ankle sprain and divide them into the FSN group and the combined treatment group. There are 30 cases in each group. The FSN group will be treated with Fu's subcutaneous needling three times a week for a total of two weeks. The Combined treatment group will wear ankle orthotics from 9:00 to 20:00, and complete resistance exercise training every day for a total of two weeks.Patients will be followed up for 6 months after the treatment. The main efficacy index is the change value of the Visual Analog Scale (VAS) compared to the baseline after 2 weeks of treatment. The secondary indicators include active range of motion (ROM) of the ankle joint, Star Excursion Balance Test (SEBT), and the Foot and Ankle Ability Measure (FAAM) to prove the clinical efficacy.
Ethics and dissemination: This study strictly adheres to the ethical guidelines of the Declaration of Helsinki.This study has passed the review of the Ethics Committee of Guangdong Provincial Hospital of Chinese Medicine. Approval No.: YF 2025 - 158 - 01. All subjects will sign a written informed consent form. The research results will be publicly published in journals indexed by SCI.
Keywords: Fu's subcutaneous needling, Ankle sprain, Postacute lateral ankle sprain, Chronic ankle instability, Functional rehabilitation, Balance, Non-surgical therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FSN group | Experimental | Procedure: Fu's Subcutaneous Needling therapyParticipants first assume the supine position. After routine disinfection, the Fu's subcutaneous needle is inserted parallelly into the subcutaneous loose connective tissue around the pathologically taut muscles (such as the tibialis anterior, peroneus longus, gastrocnemius, soleus, peroneus brevis, and extensor digitorum longus, etc.). After the needle is fully inserted, fix the protruding part of the hose holder onto the card slot.To minimize the participants' perception of pain, the doctor uses the index finger and ring finger to perform a smooth, gentle, and fan-shaped swinging motion in an alternating front-to-back manner.The sector angle is approximately 60°. It makes a total of round - trips 45 times within 30 seconds. The rocking motion is accompanied by Reperfusion Approach: A set of procedures consists of 20 times of rocking followed by 10 seconds of reperfusion method. Each target lesioned tense muscle requires 2 - 3 sets of the above - mentioned procedures. |
| combined treatment group | Active comparator | Behavioral: Ankle joint aids combined with exercise therapyParticipants in the combination therapy group wore ankle orthoses during their daily activities from 9:00 to 20:00 every day for a total of 2 weeks. During the treatment with ankle joint orthosis, complete the resistance training every day. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Patients with first-time lateral ankle sprains
- 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.
- 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.
- Auxiliary examinations: No fracture or dislocation was found in the patient during the examination, and no fracture was detected by X-ray examination.
- The patient's sprain time is more than 3 weeks and within 6 months.
Key exclusion criteria (8 listed)
- Those with complete rupture of fractures or soft tissues such as muscles, tendons, and ligaments
- Patients with severe primary diseases such as heart, liver, kidney, hematopoietic system diseases and mental diseases
- Patients with tumors or tuberculosis in the ankle joint
- Patients with rheumatic and rheumatoid arthritis, or gout.
- 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.
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 |
|---|---|---|
| Fu's Subcutaneous Needling therapyParticipants first assume the supine position. After routine disinfection, the Fu's subcutaneous needle is inserted parallelly into the subcutaneous loose connective tissue around the pathologically taut muscles (such as the tibialis anterior, peroneus longus, gastrocnemius, soleus, peroneus brevis, and extensor digitorum longus, etc.). After the needle is fully inserted, fix the protruding part of the hose holder onto the card slot.To minimize the participants' perception of pain, the doctor uses the index finger and ring finger to perform a smooth, gentle, and fan-shaped swinging motion in an alternating front-to-back manner.The sector angle is approximately 60°. It makes a total of round - trips 45 times within 30 seconds. The rocking motion is accompanied by Reperfusion Approach: A set of procedures consists of 20 times of rocking followed by 10 seconds of reperfusion method. Each target lesioned tense muscle requires 2 - 3 sets of the above - mentioned procedures. | Procedure or surgery | FSN group |
| Ankle joint aids combined with exercise therapyParticipants in the combination therapy group wore ankle orthoses during their daily activities from 9:00 to 20:00 every day for a total of 2 weeks. To ensure standardization, a unified specification is selected for the ankle joint orthosis: Product number: 100159548, the 195R Super Sports Ankle Brace for Inversion/Eversion Sprains and Ligament Fixation by McDavid from the United States. During the treatment with ankle joint orthosis, complete the resistance training every day. | Behavioural | combined treatment group |
Primary outcome
Visual Analog Scale (VAS)
Time frame: The evaluators measure the outcomes at the baseline, on day 7, day 14, and during the follow - up period (day 28, day 42, 3 months, and 6 months after the start of treatment).
The scoring range of the Visual Analogue Scale (VAS) is 0 - 100 mm, which is used for objectively quantifying the pain level. The participants were instructed to indicate the severity of their ankle pain by marking a point on a continuous horizontal line segment, with 0 mm representing the least pain and 100 mm representing the most severe pain.
4 secondary outcomes
active range of motion of the ankle joint
Time frame: was measured at the baseline, on the 14th day, and during the follow - up period.
The Star Excursion Balance Test
Time frame: at the baseline, on the 7th day, on the 14th day, and during the follow-up period.
The Foot and Ankle Ability Measure
Time frame: at the baseline, on the 14th day, and during the follow - up period.
Cumberland Ankle Instability Tool
Time frame: at the baseline, on the 14th day, and during the follow - up period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Background: PubMed 32458531Pierobon A, Raguzzi I, Solino S, Salzberg S, Vuoto T, Gilgado D, Perez Calvo E. Minimal detectable change and reliability of the star excursion balance test in patients with lateral ankle sprain. Physiother Res Int. 2020 Oct;25(4):e1850. doi: 10.1002/pri.1850. Epub 2020 May 26.
- Background: PubMed 35062990Goulart Neto AM, Maffulli N, Migliorini F, de Menezes FS, Okubo R. Validation of Foot and Ankle Ability Measure (FAAM) and the Foot and Ankle Outcome Score (FAOS) in individuals with chronic ankle instability: a cross-sectional observational study. J Orthop Surg Res. 2022 Jan 21;17(1):38. doi: 10.1186/s13018-022-02925-9.
- Background: PubMed 16920769de Noronha M, Refshauge KM, Herbert RD, Kilbreath SL, Hertel J. Do voluntary strength, proprioception, range of motion, or postural sway predict occurrence of lateral ankle sprain? Br J Sports Med. 2006 Oct;40(10):824-8; discussion 828. doi: 10.1136/bjsm.2006.029645. Epub 2006 Aug 18.
- Background: PubMed 16935061Hiller CE, Refshauge KM, Bundy AC, Herbert RD, Kilbreath SL. The Cumberland ankle instability tool: a report of validity and reliability testing. Arch Phys Med Rehabil. 2006 Sep;87(9):1235-41. doi: 10.1016/j.apmr.2006.05.022.
- Derived from this study: PubMed 41764543Chen L, Zhang Y, Chen C, Chen X, Sun J. Fu's subcutaneous needling versus bracing combined with exercise therapy in the treatment of postacute lateral ankle sprain and the prevention of chronic ankle instability: a randomized controlled trial protocol. J Orthop Surg Res. 2026 Feb 28;21(1):239. doi: 10.1186/s13018-026-06719-1.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Fu's Subcutaneous Needling therapy and Ankle joint aids combined with exercise therapy in people with Chronic Ankle Instability and Lateral Ankle Sprain, run by Guangzhou University of Chinese Medicine.
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 8 inclusion and 8 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: opening soon, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lingjing Chen (19120517097, 19120517097@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: The evaluators measure the outcomes at the baseline, on day 7, day 14, and during the follow - up period (day 28, day 42, 3 months, and 6 months after the start of treatment).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07161427, which also lists 5 linked publications.
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 16 Sep 2025.