Clinical Evaluation of Surrounding Electroacupuncture in the Treatment of Acute Lateral Ankle Sprain

NCT ID: NCT06182943

Last Updated: 2023-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-23

Study Completion Date

2026-11-22

Brief Summary

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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

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1. 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.
2. 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.
3. 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.
4. 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

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Electroacupuncture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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electroacupuncture group

electroacupuncture combined with surrounding acupuncture

Group Type EXPERIMENTAL

electroacupuncture combined with surrounding acupuncture

Intervention Type OTHER

electroacupuncture combined with surrounding acupuncture

sham electroacupuncture group

sham electroacupuncture

Group Type SHAM_COMPARATOR

sham electroacupuncture

Intervention Type OTHER

sham electroacupuncture

ice compress combined with brake rest group

ice compress combined with brake rest

Group Type PLACEBO_COMPARATOR

ice compress combined with brake rest

Intervention Type OTHER

ice compress combined with brake rest

Interventions

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electroacupuncture combined with surrounding acupuncture

electroacupuncture combined with surrounding acupuncture

Intervention Type OTHER

sham electroacupuncture

sham electroacupuncture

Intervention Type OTHER

ice compress combined with brake rest

ice compress combined with brake rest

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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;

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Third Affiliated hospital of Zhejiang Chinese Medical University

OTHER

Sponsor Role lead

Responsible Party

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Hu Qimiao

lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xianming Lin, Phd

Role: STUDY_CHAIR

The Third Affiliated hospital of Zhejiang Chinese Medical University

Locations

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The Third Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Qimiao Hu, Phd

Role: CONTACT

Phone: +86 151 5817 5001

Email: [email protected]

Facility Contacts

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Xianming Lin, Phd

Role: primary

Other Identifiers

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ZSLL-ZN-2023-011-01

Identifier Type: -

Identifier Source: org_study_id