UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000057777 |
|---|---|
| Receipt number | R000066004 |
| Scientific Title | Effect of Prolonged Continuous Microcurrent Therapy on Acute Lateral Ankle Ligament Injury: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/05/15 |
| Last modified on | 2025/05/12 19:52:52 |
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Basic information
Public title
A Study on the Effect of Microcurrent Therapy for Ankle Sprains (Randomized Controlled Trial)
Acronym
Microcurrent & Ankle Sprain Study
Scientific Title
Effect of Prolonged Continuous Microcurrent Therapy on Acute Lateral Ankle Ligament Injury: A Randomized Controlled Trial
Scientific Title:Acronym
ALMS Trial
Region
| Japan |
Condition
Condition
Acute Ankle Sprain
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 23 | 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 sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yuzuru |
| Middle name | |
| Last name | Itoh |
Organization
Nippon Sport Science University
Division name
Sports Cure Center: Yokohama Kenshidai Judo Therapy Clinic, Nippon Sport Science University
Zip code
2270033
Address
1221-1 Kamoshida-cho, Aoba-ku, Yokohama-shi, Kanagawa, Japan
TEL
0454796262
itoh@nittai.ac.jp
Public contact
Name of contact person
| 1st name | shun |
| Middle name | |
| Last name | sugisawa |
Organization
Nippon Sport Science University
Division name
Sports Cure Center: Yokohama Kenshidai Judo Therapy Clinic, Nippon Sport Science University
Zip code
2270033
Address
1221-1 Kamoshida-cho, Aoba-ku, Yokohama-shi, Kanagawa, Japan
TEL
0454796262
Homepage URL
s-sugisawa@nittai.ac.jp
Sponsor or person
Institute
Nippon Sport Science University
Institute
Department
Personal name
Funding Source
Organization
Not
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
itolator
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nippon Sport Science University
Address
1221-1 Kamoshida-cho, Aoba-ku, Yokohama-shi, Kanagawa, Japan
Tel
0357060931
rinri-shinsa@nittai.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 05 | Month | 05 | Day |
Last modified on
| 2025 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000066004
