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IRCT20260419069106N1 IRCT 2026-07-29 Tehran University of Medical Sciences Comparing the effect of corticosteroid injection and high intensity laser in patients with chronic plantar fasciitis. Comparing the effect of corticosteroid injection versus high intensity laser on pain and function in patients with chronic plantar fasciitis referred to Imam Khomeini and Shariati hospitals , a single-blind clinical trial. 2026-05-04 anticipated 40 Recruiting https://irct.ir/trial/89822 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be divided into two groups using a simple randomization method: - Group A: High intensity laser therapy with determinate protocol Group B: Corticosteroid injection (A combination of 1ml triamcinolone 40 mg and 2 ml lidocaine 2%) in maximum pain location, Blinding description: This study is designed as a single-blind study. Patients will not be aware of the type of intervention. The physician will inevitably be aware of the technique, but the clinical assessor (who will record VAS and FFI at subsequent visits) will be completely unaware of the group allocation of patients. N/A Plantar fasciitis/heel spur. Intervention 1: Intervention group: laser therapy with novin med High intensity laser therapy device in 2 or 3 sessions weekly for 8 sessions. first to fourth sessions protocol is :/area : 49 /fr : 30 /total 735j / time 4’:05” Mode: pulsed / peak power :8 / average power : 3 / dose : 15 j/cm²• fifth to eights sessions protocol is :/area : 49 /fr : 30 /total 1470j / time 4’:54” Mode: pulsed / peak power :15 / average power : 5 / dose : 30 j/cm². Intervention 2: Intervention group: After obtaining informed consent, Corticosteroid injection with palpitation technique will be perform in maximum pain location. Injection will be in 1 session and is combination injection of 1 ml triamcinolone 40 mg and 2 ml lidocaine 2%. Yes - There is a plan to make this available What will be shared: After deidentifying people, all the data obtained from the research, including the demographic information of the samples, clinical information and the results of the intervention can be shared. When: It is possible to access the results after nine to twelve months from the publication of the results. To whom: Researchers in academic centers and scientific research centers. Conditions: In order to data comparison in similar studies, the researchers of academic centers and scientific research centers have the possibility to receive data and re-analyze it if they comply with the principles of ethics in research. Where to obtain: dr.hadi ghobadi marallu with email of : hadighobadi124@gmail.com and phone number of 09217499821 How to obtain: Researchers should send a written request to receive data to the relevant email address.A week after receiving an email , it will take action. Comments:
public Hadi Ghobadi Marallu
Enghelab Square,borhani alley , enghelab dorm
Tehran Iran (Islamic Republic of) 1344619546 +98 921 749 9821 hadighobadi124@gmail.com Tehran University of Medical Sciences scientific Hadi Ghobadi Marallu
Enghelab square
Tehran Iran (Islamic Republic of) 1417913191 +98 21 6696 5500 hadighobadi124@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Age 18-65 years Clinical diagnosis confirmed by a physician Failure to respond to conservative treatment Plantar fasciitis up to 2 months Ability to cooperate in the study 18 years 65 years Both History of surgery within the last year for plantar fasciitis Injection therapy Laser or shockwave therapy within the last 2 months Use of Plavix within the last week M72.2 Plantar fascial fibromatosis Treatment - Other Treatment - Drugs Intervention group: laser therapy with novin med High intensity laser therapy device in 2 or 3 sessions weekly for 8 sessions. first to fourth sessions protocol is :/area : 49 /fr : 30 /total 735j / time 4’:05” Mode: pulsed / peak power :8 / average power : 3 / dose : 15 j/cm²• fifth to eights sessions protocol is :/area : 49 /fr : 30 /total 1470j / time 4’:54” Mode: pulsed / peak power :15 / average power : 5 / dose : 30 j/cm² Intervention group: After obtaining informed consent, Corticosteroid injection with palpitation technique will be perform in maximum pain location. Injection will be in 1 session and is combination injection of 1 ml triamcinolone 40 mg and 2 ml lidocaine 2% Determination and comparison of the mean pain score (VAS) at 2 weeks and 12 weeks after the end of procedure in patients with plantar fasciitis in two groups of high intensity laser and corticosteroid injection. Timepoint: Change in mean pain and function intensity score based on the Visual Analogue Scale (VAS) from baseline to 2 weeks and 12 weeks after corticosteroid injection or using of high intensity laser. Method of measurement: The Visual Analog Scale (VAS) will be used to assess the severity of patients' pain, and the Foot Function Index (FFI) questionnaire will be used to assess foot function. Scores for both instruments will be collected and recorded through direct patient questionnaires.Visual Analog Scale (VAS): This instrument is used to measure pain severity and is designed based on the Likert scale. In this scale, pain severity is reported as a number from 0 to 10, with 0 indicating complete absence of pain and 10 indicating the most severe pain imaginable.Foot Function Index (FFI): This questionnaire is used to assess the degree of foot dysfunction and consists of 17 questions categorized into three subscales: pain (5 questions), disability (9 questions), and mobility limitation (3 questions). Each question is scored numerically from 0 to 10. The final score for each subscale is calculated from the sum of the scores for its questions and determines the patient's level of pain, disability, and mobility limitation. Determination and comparison of the mean function score (FFI score) at 2 weeks and 12 weeks after the end of procedure in patients with plantar fasciitis in two groups of high intensity laser and corticosteroid injection. Timepoint: Change in mean pain and function intensity score based on the Visual Analogue Scale (VAS) from baseline to 2 weeks and 12 weeks after corticosteroid injection or using of high intensity laser. Method of measurement: The Visual Analog Scale (VAS) will be used to assess the severity of patients' pain, and the Foot Function Index (FFI) questionnaire will be used to assess foot function. Scores for both instruments will be collected and recorded through direct patient questionnaires.Visual Analog Scale (VAS): This instrument is used to measure pain severity and is designed based on the Likert scale. In this scale, pain severity is reported as a number from 0 to 10, with 0 indicating complete absence of pain and 10 indicating the most severe pain imaginable.Foot Function Index (FFI): This questionnaire is used to assess the degree of foot dysfunction and consists of 17 questions categorized into three subscales: pain (5 questions), disability (9 questions), and mobility limitation (3 questions). Each question is scored numerically from 0 to 10. The final score for each subscale is calculated from the sum of the scores for its questions and determines the patient's level of pain, disability, and mobility limitation. Determination and comparison of possible treatment side effects at 2 weeks and 12 weeks after the end of procedure in patients with plantar fasciitis in two groups of high intensity laser and corticosteroid injection. Timepoint: Change in mean pain and function intensity score based on the Visual Analogue Scale (VAS) from baseline to 2 weeks and 12 weeks after corticosteroid injection or using of high intensity laser. Method of measurement: The Visual Analog Scale (VAS) will be used to assess the severity of patients' pain, and the Foot Function Index (FFI) questionnaire will be used to assess foot function. Scores for both instruments will be collected and recorded through direct patient questionnaires.Visual Analog Scale (VAS): This instrument is used to measure pain severity and is designed based on the Likert scale. In this scale, pain severity is reported as a number from 0 to 10, with 0 indicating complete absence of pain and 10 indicating the most severe pain imaginable.Foot Function Index (FFI): This questionnaire is used to assess the degree of foot dysfunction and consists of 17 questions categorized into three subscales: pain (5 questions), disability (9 questions), and mobility limitation (3 questions). Each question is scored numerically from 0 to 10. The final score for each subscale is calculated from the sum of the scores for its questions and determines the patient's level of pain, disability, and mobility limitation. Determination and comparison of patients satisfaction at 2 weeks and 12 weeks after the end of procedure in patients with plantar fasciitis in two groups of high intensity laser and corticosteroid injection. Timepoint: Change in mean pain and function intensity score based on the Visual Analogue Scale (VAS) from baseline to 2 weeks and 12 weeks after corticosteroid injection or using of high intensity laser. Method of measurement: The Visual Analog Scale (VAS) will be used to assess the severity of patients' pain, and the Foot Function Index (FFI) questionnaire will be used to assess foot function. Scores for both instruments will be collected and recorded through direct patient questionnaires.Visual Analog Scale (VAS): This instrument is used to measure pain severity and is designed based on the Likert scale. In this scale, pain severity is reported as a number from 0 to 10, with 0 indicating complete absence of pain and 10 indicating the most severe pain imaginable.Foot Function Index (FFI): This questionnaire is used to assess the degree of foot dysfunction and consists of 17 questions categorized into three subscales: pain (5 questions), disability (9 questions), and mobility limitation (3 questions). Each question is scored numerically from 0 to 10. The final score for each subscale is calculated from the sum of the scores for its questions and determines the patient's level of pain, disability, and mobility limitation. Determination and comparison of the distribution of demographic and clinical characteristics at the beginning of the study in patients of group of corticosteroid injection and group of high intensity laser. Timepoint: in the begginig of sessions. Method of measurement: The Visual Analog Scale (VAS) will be used to assess the severity of patients' pain, and the Foot Function Index (FFI) questionnaire will be used to assess foot function. Scores for both instruments will be collected and recorded through direct patient questionnaires.Visual Analog Scale (VAS): This instrument is used to measure pain severity and is designed based on the Likert scale. In this scale, pain severity is reported as a number from 0 to 10, with 0 indicating complete absence of pain and 10 indicating the most severe pain imaginable.Foot Function Index (FFI): This questionnaire is used to assess the degree of foot dysfunction and consists of 17 questions categorized into three subscales: pain (5 questions), disability (9 questions), and mobility limitation (3 questions). Each question is scored numerically from 0 to 10. The final score for each subscale is calculated from the sum of the scores for its questions and determines the patient's level of pain, disability, and mobility limitation. Tehran University of Medical Sciences Approved 2025-12-31 Ethics committee Research Ethics Committee of Dr. Shariati Hospital Three ways of Jalal Al-Ahmad Tehran Tehran Iran (Islamic Republic of)