The Effect of Fascia bar-Incorporated insole on Pain, Foot Function, and Quality of Life in subject with flexible flat foot and plantar fasciitis
Design
This study will be conducted as a single-blind, randomized clinical trial with two parallel intervention and control groups. The study will employ randomized allocation using the block randomization method.
Settings and conduct
This study will be conducted in orthotic clinics and physical medicine practices in Isfahan. Patients diagnosed with flexible flatfoot and plantar fasciitis will be enrolled upon obtaining informed consent. Participants will be randomly assigned to either an intervention group or a control group using a block randomization method. Evaluations will be performed at three stages. To ensure blinding, the study will be implemented as a single-blind trial, where patients remain unaware of the specific type of insole they have received
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 18 and 60 years; experiencing symptoms of plantar fasciitis for less than 6 months (acute phase); pain localized to the medial central aspect of the heel with greater intensity during the first steps in the morning; and the ability to use foot orthoses for at least 6 hours per day.
Exclusion criteria: History of using foot orthoses, physiotherapy, or injections in the foot/ankle within the past 3 months; history of lower limb surgery or planned surgery within the next 12 months; pregnancy; and a body mass index greater than 30 kg/m²
Intervention groups
Intervention: Custom-fit full-length insoles, two-part medial longitudinal arch support. Heel: Cushioning foam (30-35 hardness). Midfoot/forefoot: Semi-rigid foam (40 hardness) with fascia bar. Control: Similar insoles, no fascia bar. Duration: 4 weeks, min. 6 hours daily. Manufacturer: Senrest, Isfahan
Main outcome variables
Pain, Foot Function, and Quality of Life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250315065086N2
Registration date:2026-05-03, 1405/02/13
Registration timing:prospective
Last update:2026-05-03, 1405/02/13
Update count:0
Registration date
2026-05-03, 1405/02/13
Registrant information
Name
Fateme Pol
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3233 6289
Email address
maryam_pol68@yahoo.com
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2026-06-22, 1405/04/01
Expected recruitment end date
2026-12-22, 1405/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Fascia bar-Incorporated insole on Pain, Foot Function, and Quality of Life in subjects with flexible flat foot and plantar fasciitis
Public title
The impact of a specific type of insole on individuals with flat feet
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 60 years
History of symptoms consistent with plantar fasciitis for less than 6 months (acute phase)
Presence of pain in the medial aspect of the heel
Greater pain intensity upon first steps in the morning (first-step pain)
A minimum pain intensity of 30 mm on a 100-mm Visual Analog Scale (VAS) during the past week
Ability to use foot orthoses for at least 6 hours per day
Positive Jack’s test: the appearance of the medial longitudinal arch during hallux dorsiflexion in a standing position, indicating arch flexibility
Foot Posture Index (FPI) ≥ +6: the sum of scores from six criteria assessing foot posture in a standing position; a score ≥ +6 indicates a pronated or flexible foot
Navicular Drop Test (NDT) ≥ 10 mm: the difference in navicular height between sitting and standing positions; a value greater than 10 mm indicates medial longitudinal arch collapse
Exclusion criteria:
Use of foot orthoses, physiotherapy, or injections in the foot or ankle within the past 3 months
History of lower limb surgery or planned surgery within the next 12 months
Allergy to orthotic materials
Cognitive impairment
Medical history of diabetes mellitus (type I or II), inflammatory joint diseases, or neuromuscular disorders
Pregnancy at the time of the study
Presence of foot deformities
History of foot or ankle fractures
Body Mass Index (BMI) greater than 30 kg/m²
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
This study will be conducted using random allocation with a block randomization method. A total sample of 48 participants will be organized into 12 blocks of four, with each block assigning two participants to the intervention group (P1) and two to the control group (P2), resulting in two equal groups of 24 participants each.
The allocation sequence will be generated by an independent statistician and maintained in sequentially numbered, opaque, sealed envelopes. Following screening and informed consent, the corresponding envelope will be opened and the participant will be assigned to the respective group.
Outcome assessors will be blinded to group allocation. Participants in group P1 will receive full-length foot orthoses with medial arch support and a fascia bar, while participants in group P2 will receive similar orthoses without a fascia bar.
The blocks are written on paper, placed inside a container, and samples are selected via a draw.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants in this study will be blinded, as they will be unable to distinguish between orthoses with a fascia bar and those without, due to their highly similar appearance.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Research and Technology Deputy, Building No. 4, Isfahan University of Medical Sciences and Health Services, Hezar Jerib St.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2026-03-03, 1404/12/12
Ethics committee reference number
IR.MUI.REC.1404.052
Health conditions studied
1
Description of health condition studied
Flatfoot
ICD-10 code
M21.4
ICD-10 code description
Flat foot [pes planus] (acquired)
Primary outcomes
1
Description
Pain Intensity Score
Timepoint
Before receiving the insoles, immediately after receiving the insoles, and four weeks after receiving the insoles
Method of measurement
Visual Analogue Scale
2
Description
Foot Function Score
Timepoint
Before receiving the insoles and four weeks after receiving the insoles
Method of measurement
Foot Function Index questionnaire
3
Description
Quality of Life Score
Timepoint
Before receiving the insoles and four weeks after receiving the insoles
Method of measurement
Orthotics and Prosthetics Users’ Survey – Satisfaction Module questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group employs a full-length insole with an medial longitudinal arch support and a fascia bar. These insoles are custom-made and consist of two components: the heel section is constructed from foam with a hardness of 30 to 35, designed to absorb shock and reduce localized pressure, while the midfoot and forefoot sections are made from semi-rigid foam with a hardness of 40 to control pronation and provide support for the arch of the foot. The medial longitudinal arch support is anatomically designed to conform to the natural arch of the foot, preventing arch collapse and ensuring even pressure distribution. The insoles are made to be custom-fitted, meaning they are produced based on a prepared file that incorporates the fascia bar and adjusted solely according to the length of each participant’s foot. Furthermore, the thickness of the fascia bar is tailored to match each individual’s foot length.The fascia bar is positioned as a semi-cylindrical raise at the anterior heel and beneath the area where the calcaneus connects to the midtarsal region, measuring between 1.6 mm and 9.5 mm in thickness (with a maximum of 5 mm) and 13 mm to 64 mm in length. This structure is made from the same material as the body of the insole (foam) with a hardness of 35 to 40 (within the permissible range of 20 to 80) and continuously applies localized pressure at the heel-midfoot junction to reduce plantar fascia strain, consequently alleviating pain and enhancing foot function. The duration for using the insoles is four weeks, with a minimum recommended usage of six hours per day, and participants are instructed to refrain from other concurrent treatments or orthotic interventions during the study period.In the first session, after obtaining informed consent and completing a personal information questionnaire, participants receive a comprehensive explanation regarding the research introduction, benefits, and potential risks. In the second session, the insoles are provided free of charge, with instructions on proper use and necessary conditions for adherence to the wearing protocol. It is also noted that the manufacturer of the insoles is the Senrest Company in Isfahan. Participants are emphasized to ensure a minimum usage duration of six hours per day. Pain variable measurements are conducted at three intervals (prior to receiving the insoles, immediately after receipt, and four weeks post-receipt), while foot function and quality of life variables are assessed at two intervals (before receiving the insoles and four weeks after receipt). The researcher maintains weekly contact with participants via phone to check on their usage patterns and hours of insole application.
Category
Treatment - Devices
2
Description
Control group:A full-length insole with medial longitudinal arch support, without a fascia bar. It is manufactured from the exact same material and design as the insole used in the Intervention Group, with the exception that it lacks the fascia bar prominence.These insoles are custom-made and consist of two components: the heel section is constructed from foam with a hardness of 30 to 35, designed to absorb shock and reduce localized pressure, while the midfoot and forefoot sections are made from semi-rigid foam with a hardness of 40 to control pronation and provide support for the arch of the foot. The medial longitudinal arch support is anatomically designed to conform to the natural arch of the foot, preventing arch collapse and ensuring even pressure distribution. The insoles are made to be custom-fitted.The duration for using the insoles is four weeks, with a minimum recommended usage of six hours per day, and participants are instructed to refrain from other concurrent treatments or orthotic interventions during the study period.In the first session, after obtaining informed consent and completing a personal information questionnaire, participants receive a comprehensive explanation regarding the research introduction, benefits, and potential risks. In the second session, the insoles are provided free of charge, with instructions on proper use and necessary conditions for adherence to the wearing protocol. It is also noted that the manufacturer of the insoles is the Senrest Company in Isfahan. Participants are emphasized to ensure a minimum usage duration of six hours per day. Pain variable measurements are conducted at three intervals (prior to receiving the insoles, immediately after receipt, and four weeks post-receipt), while foot function and quality of life variables are assessed at two intervals
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Dr. Reza Kazemi
Street address
Soffeh Blvd, Isfahan, Isfahan Province
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 905 127 3139
Email
alzahra@mui.ac.ir
Web page address
https://alzahra.mui.ac.ir/fa
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Askari
Street address
Vice President for Research and Technology, Building No. 4, Isfahan University of Medical Sciences and Health Services, Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 7898
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Saina Khatibi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Orthopedics
Street address
Unit 7, No. 9, Villa Building, Villa Alley, Banafshah Miani Street, Khaneh Esfahan
City
Isfahan
Province
Isfehan
Postal code
8194819398
Phone
+98 31 3420 4418
Email
saina.khatibi1rehab@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Saina Khatibi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Orthopedics
Street address
Unit 7, No. 9, Villa Building, Villa Alley, Banafshah Miani Street, Khaneh Esfahan
City
Isfahan
Province
Isfehan
Postal code
8194819398
Phone
+98 31 3420 4418
Email
saina.khatibi1rehab@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Saina Khatibi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Orthopedics
Street address
Unit 7, No. 9, Villa Building, Villa Alley, Banafshah Miani Street, Khaneh Esfahan
City
Isfahan
Province
Isfehan
Postal code
8194819398
Phone
+98 31 3420 4418
Email
saina.khatibi1rehab@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
There is no further information
When the data will become available and for how long
There is no further information
To whom data/document is available
There is no further information
Under which criteria data/document could be used
There is no further information
From where data/document is obtainable
There is no further information
What processes are involved for a request to access data/document