Tokyo, May 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000057777) titled 'A Study on the Effect of Microcurrent Therapy for Ankle Sprains (Randomized Controlled Trial)' on May 15.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Nippon Sport Science University
Condition:
Condition - Acute Ankle Sprain
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the efficacy and safety of 12-hour continuous microcurrent therapy in male university athletes with acute lateral ankle ligament injuries (Grade 1 or Grade 2) through a placebo-controlled, double-blind, randomized controlled trial.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - A single 12-hour continuous session of microcurrent therapy will be administered following an ankle sprain.
Interventions/Control_2 - A sham condition will be established by providing a dummy device that does not deliver any electrical stimulation.
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male
Key inclusion criteria - Male participants aged 18 years or older
Injury sustained during sports activities
Within 3 hours of sustaining a lateral ankle ligament injury
Informed consent for study participation has been obtained
Key exclusion criteria - Fracture is present.
Has taken anti-inflammatory analgesics within 24 hours prior to measurement.
Has a history of ankle surgery.
Has an implanted electronic device such as a pacemaker.
Falls under contraindications for microcurrent therapy.
Has received a steroid injection in the ankle within the past 3 months.
Target Size - 60
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 02 Month 28 Day
Date of IRB - 2025 Year 03 Month 04 Day
Anticipated trial start date - 2025 Year 03 Month 04 Day
Last follow-up date - 2026 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066004
Disclaimer: Curated by HT Syndication.