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IRCT20170423033615N2 IRCT 2022-12-02 Shahid Beheshti University of Medical Sciences Comparison of the effect of triamcinolone and dexmedetomidine injections in the treatment of heel pain Comparison of the efficacy of triamcinolone and dexmedetomidine injection in the treatment of pain caused by plantar fasciitis 2022-11-30 anticipated 40 Complete https://irct.ir/trial/66987 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sampling will be done as a block randomization method. So, initially, in the Excel software, there are 6 blocks of 4 as (AA, BB), (BB, AA), (AB, BA), (BA, AB). (AB, AB), (BA, BA) are prepared and then these blocks will be arranged from one to six. A is the confirmation of the treatment or intervention group and B is the confirmation of the control group. Then one of these blocks will be randomly selected and based on the sequence of letters A and B in the selected block, the eligible people will be assigned to the treatment or control groups. The random process of selecting blocks and assigning people to the intervention and control groups will continue until the desired sample size is reached, Blinding description: For the study subjects, before the random assignment, it is explained how the work process is and they may receive one of the two treatments randomly, and the drug used for the subjects is not known in advance, the form of the intervention drug and control and also, the frequency and times of administration of these two will be similar, so that it is not possible for the patient to distinguish them from each other, so the patient will not know which group she is in. 2-3 Chronic heel pain and plantar fasciitis. Intervention 1: Intervention group: Injection of 1 microgram per kilogram of dexmedetomidine plus 2 ml lidocaine 2% under ultrasound guidance with a 22-gauge needle, after prepping the injection site with 1% betadine, is performed with a standard approach in the space between the plantar fascia and the periosteum. The injection is done in one session. Intervention 2: Control group: injection of one milliliter (40 milligram) of triamcinolone plus 2 ml of lidocaine 2%. The injection method is similar to the intervention group. Yes - There is a plan to make this available What will be shared: The whole data can be shared after unidentifiable people. When: Start the access period 6 months after printing the results To whom: Only available to scholars working in academic and academic institutions Conditions: Employed in research centers Where to obtain: Email to the person responsible for the study (email address: mahshidghasemi@sbmu.ac.ir). How to obtain: Send email to person responsible for scientific inquiries Comments:
public Mahshid Ghasemi MD
Sharifimanesh St.
Tehran Iran (Islamic Republic of) 1964714953 +98 21 2200 2763 mahshidghasemi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Mahshid Ghasemi MD
Sharifimanesh St.
Tehran Iran (Islamic Republic of) 1964714953 +98 21 2200 2763 mahshidghasemi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age 18 and above Patients with initial complaint of heel pain after weight bearing after a period of rest Heel pain and plantar fasciitis for more than three months Patients with unilateral chronic plantar fasciitis Failure to respond to conservative treatments Pain that goes away after a few minutes of walking but returns after prolonged walking or standing Pain caused by palpation of medial calcaneal tuberosity, dorsiflexion of the foot passively Chronic heel pain of three months or more without evidence of acute trauma to the heel VAS > 5 after taking the first step following rest Patients with satisfaction to participate in the study 18 years no limit Both Mechanical pains in the posterior part of the heel in the form of Achilles tendonitis/bursitis Neurological heel pain caused by nerve rupture Heel arthritis pain Traumatic heel pain Bilateral plantar fasciitis Heel pain for more than three months Skin ulcer around the heel and treatment of that area Sciatica pain; benign and malignant tumors; acute infection; diabetes; sensory neuropathy; peripheral vascular disease / autoimmune disease; fibromyalgia; chronic fatigue syndrome Light sensitivity disorder Pregnancy and breastfeeding M72.2 Plantar fascial fibromatosis Treatment - Drugs Treatment - Drugs Intervention group: Injection of 1 microgram per kilogram of dexmedetomidine plus 2 ml lidocaine 2% under ultrasound guidance with a 22-gauge needle, after prepping the injection site with 1% betadine, is performed with a standard approach in the space between the plantar fascia and the periosteum. The injection is done in one session. Control group: injection of one milliliter (40 milligram) of triamcinolone plus 2 ml of lidocaine 2%. The injection method is similar to the intervention group. Pain level. Timepoint: Before starting treatment, 4 and 12 weeks after injection. Method of measurement: Visual analog scale (VAS) (0 None; 1-3 Mild; 4-7 Moderate; 8-10 Severe). Shahid Beheshti University of Medical Sciences Approved 2022-11-12 Ethics committee of Shahid Beheshti University of Medical Sciences Tabnak Street Tehran Tehran Iran (Islamic Republic of)