Ultrasound-guided Prolotherapy, Oxygen-ozone and corticosteroid injection for the treatment of plantar fasciitis: A randomized, double-blind, multi-center study.

To compare effect of ultrasound guided Corticosteroid, Ozone and Dextrose injection in patients with Plantar fasciitis.

A phase 3, umulticenteral, randomized, double blinded, clinical trial with a parallel group, and one week and two months followed ups. 1 cc lidocaine 2% will be used for local anesthesia (skin) in all groups. Then, under sterile condition, one group will be received ultrasound guided Ozone injection from medial heel with 25G needle. Other groups will receive corticosteroid or dextrose prolotherapy.

patients with plantar fasciitis referred to physiatrists clinics in Iran and Tabriz (University of Medical Sciences)

Inclusion criteria: More than three months of heel pain which is worst with the first few steps after awakening. Pain and tenderness by palpation of the medial calcaneal or the proximal plantar fascia. VAS greater or equal to 4. Sonographic plantar fascia thickness greater than 4 mm with hypoechoic change. Exclusion criteria: History of ankle or calcaneal trauma. Positive Tinel’s sign on the tibial nerve. History of systemic inflammatory or connective tissue disease. 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. Initiation of PF treatment within 10 days before intervention such as NSAIDs or physical therapy. History of vascular insufficiency causing heel pain.

Three ultrasound guided injection groups : 1.Corticosteroid, 2.Ozone 3.Dextrose

Visual Analogue Scale, Foot and Ankle Ability Measure

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.

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.

Data will only be provided for journal during manuscript submission or for meta-analysis at the specific request of other individuals.

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