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IRCT20170105031787N2 IRCT 2018-01-11 Iran University of Medical Sciences Using of short leg splint for immobilization A comparison of the immobilization results of lower extremity injuries with two method of short leg standard Splint and half length standard Splint 2018-02-04 anticipated 300 Complete https://irct.ir/trial/28403 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly assigned to two groups. In order to randomize, a random block method is used. For this purpose, we formed blocks with 10 person. In each block, 5 individuals will be in short leg standard Splint and 5 will be in half length standard Splint groups. A total of 30 blocks will be considered for sample size. In case group bracing up will be done by using half size splint (from the toes until middle of the leg) and in the control group it will be done by using a regular splint (from the toes until 4 cm below the knee). General information and medical prescription and same advice are implemented for both groups. Data will analyze by person who is blind to study groups (single blind), Blinding description: Data will analyze by person who is blind to study groups (single blind). N/A Lower limb soft tissue injuries. Intervention 1: Intervention group: Half regular size short splint of lower limb in intervention group. Intervention 2: Control group: Regular size of short splint of lower limb in control group. 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 After completing the work and consulting with all the writers and executive agents, I will be decided.
public Afshin Shokooh Saremi
Rasoul-Akram Hospital, Niayesh St., Sattarkahn Ave
Tehran Iran (Islamic Republic of) 1591634312 +98 21 6641 3523 e_sh.saremi@yahoo.com Iran University of Medical Sciences scientific Mohammad-Reza Yasinzadeh
Rasoul-Akram Hospital, Niayesh St., Sattarkahn Ave
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6652 5327 yasinzadeh.mr@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: Patients, who admitted in the emergency department of “7tir Hospital” in Tehran with a complaint of lower limb trauma and need splinting 18 years 140 years Both Exclusion criteria: Patients under eighteen years old and those that can not be follow up will be rolled out. Patients who had long bone fracture Patients who had lower limb rupture Patients who had dislocation Patients who had laceration needs to repair Treatment - Other Treatment - Other Intervention group: Half regular size short splint of lower limb in intervention group Control group: Regular size of short splint of lower limb in control group Recovery time. Timepoint: every week from splinting to removal time. Method of measurement: telephone or in-person interviews with patients. Swelling. Timepoint: Before intervention; one week after intervention; two weeks after intervention; three weeks after intervention. Method of measurement: telephone or in-person interviews with patients. Pain. Timepoint: every week until 3 weeks from splinting. Method of measurement: telephone or in-person interviews with patients according to pain score. Complication such as compartment syndrome, burning of skin or sore. Timepoint: every week from splinting to removal time. Method of measurement: telephone or in-person interviews with patients. Tolerance. Timepoint: every week from splinting to removal time. Method of measurement: telephone or in-person interviews with patients. Iran University of Medical Sciences Approved 2017-05-22 Ethics committee of Iran University of Medical Sciences Shahid Hemmat highway, Tehran,Iran. Tehran Tehran Iran (Islamic Republic of)