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IRCT20210305050582N1 IRCT 2021-03-19 Shiraz University of Medical Sciences Prolotherapy and corticosteroid injection in plantar fasciitis Comparison the effect of ultrasound guided prolotherapy and ultrasound guided corticosteroid injection on pain score and foot function in patients with plantar fasciitis. 2021-03-10 anticipated 44 Complete https://irct.ir/trial/54847 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will allocate to the either corticosteroid or prolotherapy groups by block randomization. Block randomization will be done by random blocks of four with letters A and B, without replacement. For example, for AABB block, the first two patients will include group A and the latter two patients will include group B. Allocation of treatment to the groups A and B will be done by simple randomization, using a coin, Blinding description: In the present study, the participant, the physician; who who performs the procedure; and the study assistant; who is the responsible of patients' follow up; will be blinded to the groups allocation. N/A Plantar fasciitis. Intervention 1: Intervention group 1: Treatment with local injection of 40 mg methyl prednisolone acetate and 1 milliliter of 2% lidocaine solution under ultrasound guide with plantar approach. A 23 gauge needle will be used for injection. Intervention 2: Intervention group 2: Treatment with injection of 1 milliliter of 50% dextrose solution and 1 milliliter of 2% lidocaine solution under ultrasound guide with plantar approach. A 23 gauge needle will be used for injection. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is The necessity of the permission of the attending professor
public Fateme Alaei
2nd floor, No. 3, Isar 17th Alley, Paeizan Avenue, Isar Town
Qom Iran (Islamic Republic of) 3713176319 +98 25 3270 4132 ftm.alaei@gmail.com Shiraz University of Medical Sciences scientific Aref Nasiri
Shiraz Faculty of Medicine, Imam Hossein Sq., Zand Ave.
Shiraz Iran (Islamic Republic of) 7134845794 +98 71 3230 5887 nasirisha@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Patients with plantar fasciitis. No analgesic using during the study. Over 18 years of age. 18 years no limit Both Patients with ankylosing spondylitis. Patients with Reiter's syndrome. Patients with rheumatoid arthritis. Patients with gout disease. Anatomical disturbance in the site of the lesion. Drug sensitivity to corticosteroids or lidocaine. Any local injection for plantar fasciitis within the past 6 months (including corticosteroid, platelet rich plasma, prolotherapy and lidocaine). Known coagulopathy. Pregnancy or lactation. M70-M79 Other soft tissue disorders Treatment - Drugs Treatment - Drugs Intervention group 1: Treatment with local injection of 40 mg methyl prednisolone acetate and 1 milliliter of 2% lidocaine solution under ultrasound guide with plantar approach. A 23 gauge needle will be used for injection. Intervention group 2: Treatment with injection of 1 milliliter of 50% dextrose solution and 1 milliliter of 2% lidocaine solution under ultrasound guide with plantar approach. A 23 gauge needle will be used for injection. The patients' reported pain score based on visual analog scale (VAS). Timepoint: Before the intervention, first month and third month. Method of measurement: Patients will quantify their pain by VAS using the numbers 1; for the least severity; to 10; for the most severity; of he pain. The foot function index (FFI). Timepoint: Before the intervention, first month and third month. Method of measurement: Standard FFI questionnaire. Shiraz University of Medical Sciences Approved 2019-09-16 Ethics committee of Shiraz University of Medical Sciences Faculty of research, Floor 7th, Central Building of Shiraz University of Medical Sciences, Zand Ave. Shiraz Fars Iran (Islamic Republic of)