This research is a clinical trial study. Using the formula for comparing the mean in community with alpha 0.05 and
the ability (power) of 99% (1-beta:99%) as well as using the result of the same article (Baldassin et al), the sample size was calculated as 22 patients for each group. Taking into account the 20% drop, 27 patients for each group were
.determined as the final sample size.
Patients will be randomly allocated in to two groups by Block Randomization Assignment and Double blind
methods. We will describe the mechanism of the disease, various approaches of treatment, prognosis and our study
process as well as case selection for each patient.
). After the eligibility is determined, all subjects will be evaluated by one of the colleagues who will obtain baseline
characteristic data of the participants including age, sex, weight, duration of symptoms, history of analgesic
consumption. He/she will train stretching exercise of the plantar fascia and calf muscles as well as ask the items of both
questionnaires. He/she will not know the type of orthoses prescribed for each patient. If both heels are painful,
only the data from the most symptomatic foot will be analyzed. If the pain severity is similar in both feet, only the
right foot will be evaluated. All patients will be advised to test the foot orthoses on
their footwear. If a participant complained of discomfort, he/she will be advised to use the orthosis for a minimum of one
week. If the orthosis still bothers the participant, he/she will be advised to return to our clinic (center of Orthosis and
Prosthesis in Shahid Chamran Hospital) for further evaluation. For improvement of blinding
method, both orthoses will be received by patients in our clinic. All insoles will tried to be made as similar as possible
in terms of materials. Each participant
will be advised not to show his/her orthosis to the questioner who will apply the scales. Each patient in both groups
should perform stretching exercises for plantar fascia and calf muscles with 5-10 times repetition in 3 sets per day which will be trained by one of the colleagues in the first visit.
.Descriptive Statistics: To describe quantitative variables, mean +_ standard deviation and 95% confidence interval
as well as to describe qualitative variables, frequency and frequency percentage will be used.
Inferential statistics: Independent sample t-test (nonparametric equivalent: Mann-Whitney test) which will be used
to compare the two groups in each time and also repeated measurement test (nonparametric equivalent: Friedman
test) will be used to check the comparison of times in each group.
Relationship between qualitative demographic variables such as gender and VAS, FFI scores through Independent
sample t-test (Mann-Whitney test) and the relationships of quantitative variables such as age, symptom duration and
weight with VAS and FFI scores will be determined by the Pearson correlation coefficient (nonparametric
equivalent: Spearman).
.SPSS25 will be used to analyze the data and the significance level in each of the tests is 0.05.
Patients will be randomly allocated in to two groups by Block Randomization Assignment and Double blind
methods. We will describe the mechanism of the disease, various approaches of treatment, prognosis and our study
process and case selection for each patient. After the eligibility is determined, all subjects will be evaluated by one of the colleagues who will obtain baseline
characteristic data of the participants including age, sex, weight, duration of symptoms and history of analgesic
consumption. He/she will train stretching exercise of the plantar fascia and calf muscles as well as ask the items of both
questionnaires. He/she will not know the type of orthoses prescribed for each patient. If both heels are painful,
only the data from the most symptomatic foot will be analyzed. If the pain severity is similar in both feet, only the
right foot will be evaluated. The colleagues who provide the services in all steps of the project as well as analyzers will be blinded. For improvement of blinding
method, both orthoses will be received by patients in our clinic. All insoles will tried be made as similar as possible
in terms of materials. Each participant
will be advised not to show his/her orthosis to the questioner who will apply the scales. Each patient in both groups
should perform stretching exercises for plantar fascia and calf muscles with 5-10 times repetition in 3 sets per day which will be trained by one of the colleagues in the first visit.