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IRCT20191129045542N2 IRCT 2022-07-17 Shiraz University of Medical Sciences Comparative Effectiveness of the Customized poly-propylene Semi-rigid Insole and Prefabricated SiliconeHeel Pad in Pain Reduction and Functional Improvement of Patients with Plantar Fasciitis Comparative Effectiveness of the Customized poly-propylene Semi-rigid Insole and Prefabricated Silicone Heel Pad in Pain Reduction and Functional Improvement of Patients with Plantar Fasciitis, A Clinical Trial Study. 2022-08-04 anticipated 54 Complete https://irct.ir/trial/64749 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 2 plantar fasciitis. Intervention 1: Intervention group: prefabricated silicone heel pad. Intervention 2: Intervention group: customized semi rigid polypropylene insole. No - There is not a plan to make this available Justification or reason for not sharing IPD is No need
public Leila Sadat Mohamadi Jahromi
Zand street
Shiraz Iran (Islamic Republic of) 0098 +98 937 535 1951 mohamadil.2668@gmail.com Shiraz University of Medical Sciences scientific Leila Sadat Mohamadi JahromiS
Zand street, Faqihi hospital
Shiraz Iran (Islamic Republic of) 0098 009836486064 mohamadil.2668@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) - Sharp, shooting or localized pain in the sole of the foot for at least one month- 18 year-old patients or older.- Tenderness along the posteromedail aspect of the longitudinal arch or medial calcaneal tubercle.- Start-up pain in the morning with ambulation.- Decrease pain after walking 18 years no limit Both - Any lower extremity injuries including foot and ankle within 6 months.- Stress fracture- Receiving plantar steroid injection within 3 months.- Use of nonsteroidal anti-inflammatory medications within the previous one week.- Use of custom foot orthotics previously.- Other painful foot condition such as bunion, corn, or ingrown toe nail.- Any other lower extremity neuromuscular conditions such as active radiculopathy- Non-ambulatory, non-communicative.-Unable to complete the interview .- Spasticity due to a neurologic disorder.-Previous foot surgery.- Congenital defects of the lower extremity..- Diabetic mellitus M72.2 Plantar fascial fibromatosis Treatment - Devices Treatment - Devices Intervention group: prefabricated silicone heel pad Intervention group: customized semi rigid polypropylene insole Pain reduction and foot functional improvement. Timepoint: Before, 3 and 12 weeks after treatment. Method of measurement: Visual Analog Scale, Foot Function Index. Shiraz University of Medical Sciences Approved 2022-05-23 Ethics committee of Shiraz University of Medical Sciences ZAND Shiraz Fars Iran (Islamic Republic of)