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

NCT06182943 | Recruiting

• 1 other identifier: ZSLL-ZN-2023-011-01
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Electroacupuncture

Outcome Measures

Primary Outcomes (1)

• 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.

  before treatment（baseline,week0）, after treatment(week4) and 1 week after treatment（follow-up,week5）.

Secondary Outcomes (2)

• musculoskeletal ultrasound quantitative measurement

  before（baseline,week0）and after treatment(week4).

• circumference of ankle joint

  before treatment（baseline,week0）, after treatment(week4) and 1 week after treatment（follow-up,week5）.

Study Arms (3)

electroacupuncture group

EXPERIMENTAL

electroacupuncture combined with surrounding acupuncture

Other: electroacupuncture combined with surrounding acupuncture

sham electroacupuncture group

SHAM COMPARATOR

sham electroacupuncture

Other: sham electroacupuncture

ice compress combined with brake rest group

PLACEBO COMPARATOR

ice compress combined with brake rest

Other: ice compress combined with brake rest

Interventions

electroacupuncture combined with surrounding acupuncture OTHER

electroacupuncture combined with surrounding acupuncture

electroacupuncture group

sham electroacupuncture OTHER

sham electroacupuncture

sham electroacupuncture group

ice compress combined with brake rest OTHER

ice compress combined with brake rest

ice compress combined with brake rest group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Third Affiliated hospital of Zhejiang Chinese Medical University: lead

Study Sites (1)

The Third Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310000, China

RECRUITING

Study Officials

• Xianming Lin, Phd

  The Third Affiliated hospital of Zhejiang Chinese Medical University

  STUDY CHAIR

Central Study Contacts

Qimiao Hu, Phd

CONTACT

+86 151 5817 5001; huqimiao315@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: December 27, 2023
• Study Start: November 23, 2023
• Primary Completion: June 1, 2025
• Study Completion (Estimated): November 22, 2026
• Last Updated: December 27, 2023

Record last verified: 2023-12

Locations

CN (1)