UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053301 |
|---|---|
| Receipt number | R000060428 |
| Scientific Title | Open-label, exploratory clinical trial of electrical stimulation therapy for peroneus longus muscle in patients with hallux valgus |
| Date of disclosure of the study information | 2024/01/09 |
| Last modified on | 2024/03/11 13:11:52 |
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Basic information
Public title
Effect of electrical stimulation therapy for peroneus longus muscle in patients with hallux valgus
Acronym
Electrical stimulation therapy of peroneus longus muscle for hallux valgus
Scientific Title
Open-label, exploratory clinical trial of electrical stimulation therapy for peroneus longus muscle in patients with hallux valgus
Scientific Title:Acronym
Electrical stimulation therapy of peroneus longus muscle for hallux valgus
Region
| Japan |
Condition
Condition
Hallux Valgus
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the correction effects of electrical muscle stimulation on peroneus longus in patients with hallux valgus.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hallux valgus angle on standing plain radiograph
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Electrical muscle stimulation of the peroneus longus muscle using low frequency treatment device
Interventions/Control_2
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients who are at least 18 years of age and under 70 years of age at the time consent is obtained. (Male and female)
2. Patients who meet the diagnostic criteria of hallux valgus within one month before registration. (Hallux valgus angle less than 50 degrees)
3. Patients who can visit outpatient clinic for 28 weeks.
4. Patients who can provide written consent to participate in this study.
Key exclusion criteria
1. Patients who already performed physical therapy (strength training of the abductor hallucis muscle) within one month before registration.
2. Patients who have subluxation of the first metatarsophalangeal joint. (Hallux valgus angle over 50 degrees)
3. Patients who have dislocation of the lesser metatarsophalangeal joint.
4. Patients who have moderate flatfoot deformity. (Lateral talo-first metatarsal angle over 15 degrees)
5. Patients who take nonsteroidal anti-inflammatory drugs regularly within 4 weeks before registration.
6. History of cerebral vascular disease, neuromuscular disease, or hemiplegia.
7. History of serious side effects by low frequency treatment device.
8. Patients who meet the contraindication of the low frequency treatment device.
9. Women who are pregnant or may become pregnant, who are breastfeeding or who wish to become pregnant.
10. Patients who have participated or are willing to participate in other clinical trials during participation in the current study.
11. Patient who may suffer an unjust disadvantage by participating in this study, or disturbing the specific assessment in the current study.
12. Individuals who are investigator of the current study or employee of this hospital, or whose family.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Nobuo |
| Middle name | |
| Last name | Adachi |
Organization
Hiroshima University Hospital
Division name
Department of Orthopaedic Surgery
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082-257-5470
nadachi@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasunari |
| Middle name | |
| Last name | Ikuta |
Organization
Hiroshima University Hospital
Division name
Department of Orthopaedic Surgery
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082-257-5470
Homepage URL
yikuta@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee for Clinical Research of Hiroshima University
Address
Kasumi 1-2-3 Minami-Ku, Hiroshima
Tel
082-257-1947
iryo-sinsa@office.hiroshima-u.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
| 2024 | Year | 01 | Month | 09 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 11 | Month | 21 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 29 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 01 | Month | 09 | Day |
Last modified on
| 2024 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060428
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
