ElectroacupunctureNCT06182943
Clinical Evaluation of Surrounding Electroacupuncture in the Treatment of Acute Lateral Ankle Sprain
A study testing electroacupuncture combined with surrounding acupuncture and ice compress combined with brake rest in people with Electroacupuncture, run by The Third Affiliated hospital of Zhejiang Chinese Medical University at 1 site in China.
Trial summary
Comparison and evaluation of the difference in clinical efficacy of electroacupuncture combined with surrounding acupuncture and sham electroacupuncture groups and control group (ice compress combined with brake rest group) in the treatment of ALAS by means of musculoskeletal ultrasound technique. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Electroacupuncture
- What is being tested?
- electroacupuncture combined with surrounding acupuncture and ice compress combined with brake rest
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 23 Nov 2023to 22 Nov 2026
- 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
- Meets the diagnostic criteria for a grade I or II injury;
- Onset time≤48h;
- The patient aged between18 and 60, gender is not limited;
- The skin of the ankle joint on the affected side is intact, without breakage or ulceration;
Who cannot join
- Combined with ankle fracture;
- Grade III injury or complete ligament rupture;
- Those who cannot comply with the treatment program. Those with keloid, localized combination of other skin diseases, and those who are not suitable for electroacupuncture treatment;
- Those with serious cardiovascular, cerebrovascular, hepatic, renal, hematopoietic system or systemic failure, connective tissue disease, hemophilia, diabetes mellitus, malignant tumors, and those who are prone to bleeding tendency.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Third Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, 310000
Xianming Lin, Phd, 86-18958077816, linxianming66@126.com
About this study
Comparison and evaluation of the difference in clinical efficacy of electroacupuncture combined with surrounding acupuncture and sham electroacupuncture groups and control group (ice compress combined with brake rest group) in the treatment of ALAS by means of musculoskeletal ultrasound technique.
Read the detailed description
- To evaluate the efficacy and safety of electroacupuncture combined with surrounding acupuncture in the treatment of ALAS,and compare its differences and advantages with traditional therapy.
- To investigate the effect of electroacupuncture combined with surrounding acupuncture on the physiological and biochemical changes of the affected nerve,muscle and ligament, as well as its mechanism and pathway.
- To investigate the influence of treatment time,frequency,intensity,stimulation point and other factors on the therapeutic effect and mechanism,further optimize the treatment plan and improve the therapeutic effect and efficiency.
- To demonstrate the unique advantages and value of acupuncture analgesia,strengthen the concept and practice of integrated Chinese and Western medicine,and make contributions to promoting the application and development of acupuncture analgesia in the field of orthopedics and traumatology.
- Conditions
- Electroacupuncture
- Being tested
- electroacupuncture combined with surrounding acupuncture, sham electroacupuncture, ice compress combined with brake rest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electroacupuncture combined with surrounding acupunctureOther
electroacupuncture combined with surrounding acupuncture
sham electroacupunctureOther
sham electroacupuncture
ice compress combined with brake restOther
ice compress combined with brake rest
| Study group | Role | What they receive |
|---|---|---|
| electroacupuncture group | Experimental | electroacupuncture combined with surrounding acupuncture Receives: Other: electroacupuncture combined with surrounding acupuncture |
| sham electroacupuncture group | Sham comparator | sham electroacupuncture Receives: Other: sham electroacupuncture |
| ice compress combined with brake rest group | Placebo comparator | ice compress combined with brake rest Receives: Other: ice compress combined with brake rest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kofoed
The Kofoed evaluation system was divided into 3 items, which were evaluated before treatment, 3 weeks after treatment and after treatment. The ankle joint function was evaluated mainly from three aspects of pain, function and range of motion, with a total score of 100.
Measured: before treatment（baseline,week0）, after treatment(week4) and 1 week after treatment（follow-up,week5）.
Secondary outcomes (2)
musculoskeletal ultrasound quantitative measurement
The thickness of lateral collateral ligament of ankle joint was measured by GE LOGIQ-e portable color Doppler ultrasonography before and after treatment. The frequency of linear array probe was 8 ~ 12 mHz.
Measured: before（baseline,week0）and after treatment(week4).
circumference of ankle joint
The circumference of ankle joint was measured in 3 groups before, 3 weeks and after treatment.
Measured: before treatment（baseline,week0）, after treatment(week4) and 1 week after treatment（follow-up,week5）.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2023
- Study start23 Nov 2023
- Primary completion1 Jun 2025 (estimated)
- Study completion22 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElectroacupunctureStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Third Affiliated hospital of Zhejiang Chinese Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hu Qimiao, The Third Affiliated hospital of Zhejiang Chinese Medical University
- Investigators
- Xianming Lin, Phd, Study chair, The Third Affiliated hospital of Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06182943
- Sponsor's protocol ID
- ZSLL-ZN-2023-011-01
- Status last verified
- Dec 2023
- First submitted
- 1 Dec 2023
- Last updated
- 27 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Surrounding Electroacupuncture in the Treatment of Acute Lateral Ankle Sprain
- ClinicalTrials.gov ID
- NCT06182943
- Acronym / sponsor ID
- ZSLL-ZN-2023-011-01
- Conditions
- Electroacupuncture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- The Third Affiliated hospital of Zhejiang Chinese Medical UniversityUniversity, hospital or other
- Study start
- 23 Nov 2023 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 22 Nov 2026 (estimated)
- First posted
- 27 Dec 2023 (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.
Comparison and evaluation of the difference in clinical efficacy of electroacupuncture combined with surrounding acupuncture and sham electroacupuncture groups and control group (ice compress combined with brake rest group) in the treatment of ALAS by means of musculoskeletal ultrasound technique.
Detailed description
- To evaluate the efficacy and safety of electroacupuncture combined with surrounding acupuncture in the treatment of ALAS,and compare its differences and advantages with traditional therapy.
- To investigate the effect of electroacupuncture combined with surrounding acupuncture on the physiological and biochemical changes of the affected nerve,muscle and ligament, as well as its mechanism and pathway.
- To investigate the influence of treatment time,frequency,intensity,stimulation point and other factors on the therapeutic effect and mechanism,further optimize the treatment plan and improve the therapeutic effect and efficiency.
- To demonstrate the unique advantages and value of acupuncture analgesia,strengthen the concept and practice of integrated Chinese and Western medicine,and make contributions to promoting the application and development of acupuncture analgesia in the field of orthopedics and traumatology.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| electroacupuncture group | Experimental | Other: electroacupuncture combined with surrounding acupunctureelectroacupuncture combined with surrounding acupuncture |
| sham electroacupuncture group | Sham comparator | Other: sham electroacupuncturesham electroacupuncture |
| ice compress combined with brake rest group | Placebo comparator | Other: ice compress combined with brake restice compress combined with brake rest |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Meets the diagnostic criteria for a grade I or II injury;
- Onset time≤48h;
- The patient aged between18 and 60, gender is not limited;
- The skin of the ankle joint on the affected side is intact, without breakage or ulceration;
Key exclusion criteria (4 listed)
- Combined with ankle fracture;
- Grade III injury or complete ligament rupture;
- Those who cannot comply with the treatment program. Those with keloid, localized combination of other skin diseases, and those who are not suitable for electroacupuncture treatment;
- Those with serious cardiovascular, cerebrovascular, hepatic, renal, hematopoietic system or systemic failure, connective tissue disease, hemophilia, diabetes mellitus, malignant tumors, and those who are prone to bleeding tendency.
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 |
|---|---|---|
| electroacupuncture combined with surrounding acupunctureelectroacupuncture combined with surrounding acupuncture | Other | electroacupuncture group |
| sham electroacupuncturesham electroacupuncture | Other | sham electroacupuncture group |
| ice compress combined with brake restice compress combined with brake rest | Other | ice compress combined with brake rest group |
Primary outcome
Kofoed
Time frame: before treatment（baseline,week0）, after treatment(week4) and 1 week after treatment（follow-up,week5）.
The Kofoed evaluation system was divided into 3 items, which were evaluated before treatment, 3 weeks after treatment and after treatment. The ankle joint function was evaluated mainly from three aspects of pain, function and range of motion, with a total score of 100.
2 secondary outcomes
musculoskeletal ultrasound quantitative measurement
Time frame: before（baseline,week0）and after treatment(week4).
circumference of ankle joint
Time frame: before treatment（baseline,week0）, after treatment(week4) and 1 week after treatment（follow-up,week5）.
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 27 Dec 2023.
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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.
Xianming Lin, Phd study chair
The Third Affiliated hospital of Zhejiang Chinese Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electroacupuncture combined with surrounding acupuncture and ice compress combined with brake rest in people with Electroacupuncture, run by The Third Affiliated hospital of Zhejiang Chinese 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 4 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: looking for participants now, as of the sponsor's last update on 27 Dec 2023. 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. Some participants in this study may receive a placebo. 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 Qimiao Hu, Phd (+86 151 5817 5001, huqimiao315@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kofoed (time frame: before treatment（baseline,week0）, after treatment(week4) and 1 week after treatment（follow-up,week5）.). 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 27 Dec 2023.