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IRCT20160614028447N7 IRCT 2020-01-16 Shiraz University of Medical Sciences Evaluating the effects of Carum Copticum extract on pain and function of patients after anterior cruciate ligament repair. Evaluation of the effects of phonophoresis of Carum Copticum extract on pain and function in the first two weeks after anterior cruciate ligament repair. 2020-02-04 anticipated 50 Complete https://irct.ir/trial/44686 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization would be performed with block randomization method with block size of 4 using statistical software, Blinding description: To blind the participants, a little amount of Carum Capticum gel with 0.5% concentration would be added to routine gel in ultrasound therapy to have similar smelling with produced gel from Carum Capticum. Also, the researcher, assessor, and analyser are blind about group assignment and activity of other members of research group. 1-2 Anterior cruciate ligament repair. Intervention 1: Intervention group: stretching of tight soft tissues, strengthening and setting exercises of knee muscles, core training, ambulation, electrotherapy using Russian current, stimulation parameters: 2500 Hz, Burst: 75, ramp up: 12 sec, 12 sec: on, 50 sec: off, Carum Copticum extract phonoresis with frequency of 1 MHz, intensity of 1.5 W/cm2 for 5-10 minutes based on the volume of patients' knee. Intervention 2: Control group: Stretching of tight soft tissues, strengthening and setting exercises, core training ambulation, electrotherapy using Russian current, stimulation parameters: frequency: 2500 Hz, Burst: 75, ramp up: 2 sec, on time: 12 sec, off time: 50 sec, Routine ultrasound therapy with frequency if 1 MHz, intensity of 1.5 W/cm2, for 5-10 minutes based on the volume of patients' knee. Yes - There is a plan to make this available What will be shared: All data except personal information would be available. When: All data except personal information would be available. To whom: researchers of universities and scientific academies Conditions: Researchers can use data for advanced analyses or for meta analysis studies. Where to obtain: Dr. Amin Kordi Yoosefinejad, Shiraz, Chamran Blvd., Sheikh Abivardi 1 ave., School of Rehabilitation Sciences, Mobile: 09171950589, E-mail: yoosefinejad@sums.ac.ir How to obtain: After written request and precise explanation about using of data, data would be sent to researcher within a week. Comments:
public Amin kordi Yoosefinejad
No. 1, Sheikh Abivari Ave., Chamran Blvd., School of Rehabilitation Sciences
Shiraz Iran (Islamic Republic of) 3366971947 +98 71 3626 1081 yoosfinejad@sum.ac.ir Shiraz University of Medical Sciences scientific Amin kordi Yoosefinejad
No. 1, Sheikh Abivardi Ave., Chamran Blvd., School of Rehabilitation Sciences
Shiraz Iran (Islamic Republic of) 3366971947 +98 71 3626 1081 yoosfinejad@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Age over 18 No injuries to the lower extremities during the past 6 months Unilateral repair of anterior cruciate ligament The patient has undergone anterior cruciate ligament repair for the first time Lower extremity malformations 18 years 45 years Both Systemic diseases like diabetes with a doctor's diagnosis Patients who have allergies to women S83.5 Sprain of cruciate ligament of knee Rehabilitation Rehabilitation Intervention group: stretching of tight soft tissues, strengthening and setting exercises of knee muscles, core training, ambulation, electrotherapy using Russian current, stimulation parameters: 2500 Hz, Burst: 75, ramp up: 12 sec, 12 sec: on, 50 sec: off, Carum Copticum extract phonoresis with frequency of 1 MHz, intensity of 1.5 W/cm2 for 5-10 minutes based on the volume of patients' knee Control group: Stretching of tight soft tissues, strengthening and setting exercises, core training ambulation, electrotherapy using Russian current, stimulation parameters: frequency: 2500 Hz, Burst: 75, ramp up: 2 sec, on time: 12 sec, off time: 50 sec, Routine ultrasound therapy with frequency if 1 MHz, intensity of 1.5 W/cm2, for 5-10 minutes based on the volume of patients' knee Pain with visual analogue scale (VAS). Timepoint: At the beginning of study and at the end of study (after 2 weaks). Method of measurement: With visual analogue scale which is a 10-cm straight line with zero as without pain at one end and 10 as maximum pain at the other end. The participant sign a part of line with equals his/her pain and the sign is measured with ruler and recorded as pain measure. Inflammation. Timepoint: At the beginning of study and at the end (after two weeks of interventions). Method of measurement: Tape measurement at 15 cm below the central point of patella and 5, 10, 23 cm below the patella on both lower extremities. Passive and active range of motion of involved and sound knees. Timepoint: Before the beginning of study and at the end of study after 2 weeks of intervention. Method of measurement: Manual goniometry and Kinovea software. Weight tolerance on involved knee. Timepoint: Before the beginning of study and after 2 weeks of intervention. Method of measurement: Digital scale. Shiraz University of Medical Sciences Approved 2019-12-28 National Committee on Ethics in Biomedical Research Sheikh Abivardi 1, Chamran Blvd., Shiraz Shiraz Fars Iran (Islamic Republic of)