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IRCT20130523013442N26 IRCT 2018-09-18 Shahid Beheshti University of Medical Sciences Effect of Hyaluronic acid injection in treatment of Plantar fasciitis Comparison of effectiveness between Corticosteroid and Hyaluronic acid injection in treatment of patients with Plantar fasciitis 2018-07-25 anticipated 40 Complete https://irct.ir/trial/32750 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly placed in two groups of receiving Hyaluronic acid or Corticosteroid injection by using table of random numbers, Blinding description: The participants are unaware of exact the type of the injected drug and since the physician who inject the drug and the one who follow up them are different, the later is blinded about the injected drug. 3 plantar fasciitis. Intervention 1: Intervention group: Injection of 1ml high molecular weight Hyalorunic acid 2% (trade name "Viscor", 2500-3500 kDa, Fermentation source, 50 mg in 2.5 cc, Made in Iran) and 1 ml Lidocaine 2%, injection in the heel , injection with the guide of ultrasound, single injection. Intervention 2: Control group: Injection of 1 ml Methyl prednisolone acetate & 1 ml Lidocaine 2%, injection in the heel , injection with the guide of ultrasound, single 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 There is no further information
public Mahtab Darvish
Pasdaran St.
Tehran Iran (Islamic Republic of) 1953754163 +98 21 2283 2343 mahtab.darvish@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Seyed Ahmad Raeissadat
Shahid Arabi Ave., Yaman St., Shahid Chamran Highway
Tehran Iran (Islamic Republic of) 1985717443 +98 21 23871 a_raeissadat@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients with diagnosis of Plantar fasciitis who are visited at the Physical medicine & Rehabilitation clinic of Shahid Modarres hospital Age between 25-60 years old Having the pain since 3 months ago or more Not responding to initial conservative treatments such as shoe insoles, excercise and NSAIDs Willing to participate in the study 25 years 60 years Both Pregnancy Taking Corticosteroids or NSAIDs (oral route) in past 3 weeks or injecting corticosteroids at the site of plantar fascia in past 6 months History of vasovagal syncope Being hemodynamically unstable Recent skin or soft tissue infection at the site of injection Heel pain due to neuropathy or radiculopathy History of Diabetes Mellitus Fracture in surrounding bones Having other diseases which can cause heel pain such as Ankylosing Spondylitis or other inflammatory disorders History of surgery at Plantar Fascia M72.2 Plantar fascial fibromatosis Treatment - Drugs Treatment - Drugs Intervention group: Injection of 1ml high molecular weight Hyalorunic acid 2% (trade name "Viscor", 2500-3500 kDa, Fermentation source, 50 mg in 2.5 cc, Made in Iran) and 1 ml Lidocaine 2%, injection in the heel , injection with the guide of ultrasound, single injection Control group: Injection of 1 ml Methyl prednisolone acetate & 1 ml Lidocaine 2%, injection in the heel , injection with the guide of ultrasound, single injection Heel pain. Timepoint: Before intervention and 2 & 6 months after injection. Method of measurement: Visual Analogue Scale questionnaire. Pressure Pain Threshold. Timepoint: Before intervention and 2 & 6 months after injection. Method of measurement: Algometer. Effect of the pain on function. Timepoint: Before intervention and 2 & 6 months after injection. Method of measurement: Foot and Ankle Ability Measure (FAAM) questionnaire. Plantar fascia thickness in vertical and horizontal sections. Timepoint: Before intervention and 2 & 6 months after injection. Method of measurement: Ultrasound. Shahid Beheshti University of Medical Sciences Approved 2018-07-25 Ethic Committee of Shahid Beheshti University of Medical Sciences Shahid Beheshti University of Medical Sciences, Shahid Arabi street, Yaman street, Shahid Chamran highway Tehran Tehran Iran (Islamic Republic of)