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IRCT20210308050637N1 IRCT 2021-03-14 Shiraz University of Medical Sciences The effect of corticosteroid and dextrose injections in the treatment of osteoarthritis of the big toe joint Comparison of the effectiveness of 50% dextrose and corticosteroid injections in the treatment of osteoarthritis of the first metatarsophalangeal joint 2021-03-21 anticipated 32 Complete https://irct.ir/trial/54899 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Each of the 32 patients will be explained that they will be randomly placed in one of the intervention groups. If the patient is accepted to enter the study using a complete randomized block with Random allocation software, the patient will be placed in one of the two groups. Then, Opaque sealed envelopes are used to hide random sequences. The drugs are labeled A and B and are given to patients at random. In the end, 16 people will receive methylprednisolone and 16 people will receive 50% dextrose, Blinding description: This study is double blinded. Patients are unaware of drugs for other groups. The results analyzer is also unaware of the interventions performed in each group and for each patient. 3 Osteoarthritis of the firs metatarsophalangeal joint (Hallux rigidus). Intervention 1: Intervention group 1: 16 patient, receive corticosteroid (methylprednisolone) injection. The injection will done at one time. Dose of methylprednisolone acetate (Exir) 1 cc + 1 cc Lidocaine 2%, the injection will be under sterile conditions with a 2 cc syringe (23 gauge), which is inserted from the medial side of the joint and the injection will be done at the top and bottom. Intervention 2: Intervention group 2: 16 patients receive dextrose 50% (prolotherapy). The injection will done at one time. Prolotherapy with 1 cc dextrose 50% (Shahid Ghazi) + 1 cc Lidocaine 2%, the injection will be under sterile conditions with a 2 cc syringe (23 gauge), which is inserted from the medial side of the joint and the injection will be done at the top and bottom. Yes - There is a plan to make this available What will be shared: All data after unidentification can be shared When: Start access after publishing results To whom: Researchers working in academic institutions Conditions: Will be answered depending on the case Where to obtain: betinaz8693@gmail.com How to obtain: Send the email containing your request to the email address betinaz8693@gmail.com , it will be answered as soon as possible Comments:
public Mohammadjavad Hadianfard
Zand Ave, Shahid Faghihi hospital
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3235 1087 hadianj@sums.ac.ir Shiraz University of Medical Sciences scientific Mohammadjavad Hadianfard
Zand Ave, Shahid Faghihi hospital
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3235 1087 hadianj@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Pain in first metatarsophalangeal joint of foot No response to conventional treatments 30 years 65 years Both Rhomatologic disease Diabetes mellitus Bone infection Surgury in thr treated area Coagulative disorder Pregnancy Any injection in first metatarsophalangeal joint of foot in the last 6 months M20.2 Hallux rigidus Rehabilitation Rehabilitation Intervention group 1: 16 patient, receive corticosteroid (methylprednisolone) injection. The injection will done at one time. Dose of methylprednisolone acetate (Exir) 1 cc + 1 cc Lidocaine 2%, the injection will be under sterile conditions with a 2 cc syringe (23 gauge), which is inserted from the medial side of the joint and the injection will be done at the top and bottom Intervention group 2: 16 patients receive dextrose 50% (prolotherapy). The injection will done at one time. Prolotherapy with 1 cc dextrose 50% (Shahid Ghazi) + 1 cc Lidocaine 2%, the injection will be under sterile conditions with a 2 cc syringe (23 gauge), which is inserted from the medial side of the joint and the injection will be done at the top and bottom Pain level. Timepoint: Measurement of pain at the beginning of the study, 1 week, 4 weeks and 8 weeks after injection. Method of measurement: Visual Analog Scale. Function. Timepoint: Measurement of pain at the beginning of the study, 1 week, 4 weeks and 8 weeks after injection. Method of measurement: Manchester-Oxford Foot Questionnaire. Shiraz University of Medical Sciences Approved 2019-12-01 Ethics Committee of Shiraz University of Medical Sciences Zand ave, Shahid Faghihi hospital, Shiraz Shiraz Fars Iran (Islamic Republic of)