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IRCT20151017024572N24 IRCT 2020-08-14 Iran University of Medical Sciences Ultrasound-guided Prolotherapy, Oxygen-ozone and corticosteroid injection for the treatment of plantar fasciitis. Ultrasound-guided Prolotherapy, Oxygen-ozone and corticosteroid injection for the treatment of plantar fasciitis: A randomized, double-blind, multi-center study. 2020-09-20 anticipated 42 Complete https://irct.ir/trial/20705 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be randomly divided into three treatment groups using a table of random numbers and a centralized randomization method. In order to execute the randomization process to create a random sequence and to perform the random allocation process we will use Random Allocation Software (RAS) which will be created by statistician. Numbers created with software will be exported to the table by the statistician. Because there are more than one center for this multi-central research and for correct allocation of participants to the study groups, two hours before the patient's visit for injection, the person responsible for injection will contact the statistician by phone or text message and will ask her about the random assignment of the participant to a specific group, Blinding description: The injection material is prepared in the syringe without informing the patient and the syringes will be covered with an aluminum foil so that the participant does not know the type of injection material. Patients will be prohibited from receiving any NSAIDs or analgesics for a 15-day wash-out period prior to enrollment and intervention. Due to the different nature of ozone (gas), during the injection, there is a possibility that the injector will notice the nature of the substance under sonography. The person responsible for outcome measures and the person responsible for the statistical analysis are also kept blind. 3 Plantar Fasciitis. Intervention 1: Intervention group one: Corticosteroid, 40 mg Methylprednisolone, one time injection at the site of plantar fascia insertion. Intervention 2: Intervention group two: Ozone (O2-O3), 12 micro-gram, one time injection at the site of plantar fascia insertion. Intervention 3: Intervention group three: Prolotherapy (Dextrose 20 %), one time injection at the site of plantar fascia insertion. No - There is not a plan to make this available Justification or reason for not sharing IPD is Data will only be provided for journal during manuscript submission or for meta-analysis at the specific request of other individuals.
public Dr. Arash Babaei
Firoozgar Hospital , Valadi Ave., Valie-Asr Ave, Tehran
Tehran Iran (Islamic Republic of) 1593747812 +98 21 4128 9221 arashbabaie@gmail.com Iran University of Medical Sciences scientific Dr. Arash Babaei
Firoozgar Hospital , Valadi Ave.,Valie-Asr Ave,Tehran
Tehran Iran (Islamic Republic of) 1593747811 +98 21 4128 9221 Babaei-ghazani.a@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) More than three months of heel pain (in medial aspect) which is worst with the first few steps after awakening. Pain and tenderness elicited by palpation of the medial calcaneal or the proximal plantar fascia. Visual analog scale (VAS) score greater than or equal to 4. Sonographic plantar fascia thickness greater than 4 mm with hypoechoic change at insertion point to the calcaneus. 18 years no limit Both History of ankle or calcaneal trauma. Positive Tinel’s sign on the tibial nerve (posterior to medial malleoli). History of systemic inflammatory or connective tissue disease such as rheumatoid arthritis. History of lumbar disc herniation with S1 radiculopathy. History of gout. Uncontrolled diabetes. History of heel surgery or injections in the last six months. Cystic or mass lesion at the site of the painful heel. History of paresthesia, numbness or peripheral neuropathy. Coagulation disorder. Pregnancy. Allergic reaction to Corticosteroid or Dextrose or Ozone. Infection at the injection site. Posterior heel pain. Initiation of PF treatment within 10 days before intervention such as anti-inflammatory drug therapy, physical therapy. History of vascular insufficiency causing heel pain. M72.2 Plantar fascial fibromatosis (fasciitis) Treatment - Other Treatment - Other Treatment - Other Intervention group one: Corticosteroid, 40 mg Methylprednisolone, one time injection at the site of plantar fascia insertion Intervention group two: Ozone (O2-O3), 12 micro-gram, one time injection at the site of plantar fascia insertion Intervention group three: Prolotherapy (Dextrose 20 %), one time injection at the site of plantar fascia insertion Pain. Timepoint: Before intervention, 1 and 8 weeks after intervention. Method of measurement: Visual Analogue Scale Questionnaire. Foot and Ankle Ability Measure (FAAM). Timepoint: Before intervention, 1 and 8 weeks after intervention. Method of measurement: Foot and Ankle Ability Measure (FAAM) Questionnaire. Iran University of Medical Sciences Approved 2020-01-19 Iran University of Medical Sciences Iran University of Medical Sciences, Next to Milad Tower, Shahid Hemmat Highway, Tehran Tehran Tehran Iran (Islamic Republic of)