UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059718 |
|---|---|
| Receipt number | R000068300 |
| Scientific Title | Effect of a Stretching Intervention on Plantar Fascia Elasticity in Patients with Plantar Fasciitis: A Shear Wave Elastography Study |
| Date of disclosure of the study information | 2025/11/20 |
| Last modified on | 2025/11/10 13:09:45 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of Stretching on the Mechanical Properties of the Plantar Fascia in Patients with Plantar Fasciitis
Acronym
PF-ELAST
Scientific Title
Effect of a Stretching Intervention on Plantar Fascia Elasticity in Patients with Plantar Fasciitis: A Shear Wave Elastography Study
Scientific Title:Acronym
PF-ELAST
Region
| Japan |
Condition
Condition
Plantar Fasciitis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to elucidate the changes in the mechanical properties of the plantar fascia following stretching of the Achilles tendon and plantar fascia performed with two different time distributions in patients with plantar fasciitis, assessed by shear wave elastography.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in plantar fascia shear wave elasticity before and after stretching under four conditions: (1) continuous plantar fascia stretching (3min), (2) continuous Achilles tendon stretching (3min), (3) intermittent plantar fascia stretching (10s 10repetitions with 5s intervals), and (4) intermittent Achilles tendon stretching (10s 10repetitions with 5s intervals).
Key secondary outcomes
Clinical scores (JSSF score, SAFE-Q), plantar fascia thickness, and participant information (sex, date of birth, age, height, weight, body mass index [BMI], and presence or absence of comorbidities)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
The continuous plantar fascia stretching (3minutes) will be performed three times per day for three months.
Interventions/Control_2
The continuous Achilles tendon stretching (3minutes) will be performed three times per day for three months.
Interventions/Control_3
The intermittent plantar fascia stretching (10seconds 10repetitions with 5-second intervals) will be performed three times per day for three months.
Interventions/Control_4
The intermittent Achilles tendon stretching (10seconds 10 repetitions with 5-second intervals) will be performed three times per day for three months.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Clinically diagnosed with plantar fasciitis
1. Presence of tenderness at the calcaneal attachment of the plantar fascia
2. Duration of symptoms of at least 3 months
Key exclusion criteria
Patients with a history of systemic inflammatory diseases such as rheumatoid arthritis
Patients with a history of surgery on the foot or ankle
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Sugino |
Organization
Fukuoka University Hospital
Division name
Department of Orthopaedic Surgery
Zip code
8140180
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka 814-0180, Japan
TEL
0928716631
yuki33120517@gmail.com
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Sugino |
Organization
Fukuoka University Hospital
Division name
Department of Orthopaedic Surgery
Zip code
8140180
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka 814-0180, Japan
TEL
0928716631
Homepage URL
yuki33120517@gmail.com
Sponsor or person
Institute
Fukuoka University
Institute
Department
Personal name
Funding Source
Organization
Japan Orthopaedics and Traumatology Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuoka university hospital
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka 814-0180, Japan
Tel
0928011011
fumed-ethics@fukuoka-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
福岡大学病院(福岡県)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 20 | 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 | 10 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2028 | 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 | 11 | Month | 10 | Day |
Last modified on
| 2025 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068300
