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IRCT20191022045187N1 IRCT 2019-12-27 Shahid Beheshti University of Medical Sciences The effect of Tecar therapy on haematoma caused by hamstring muscle strain Comparison of TENS current, Ultrasound and exercise with/without Tecar therapy on muscle haematoma, pain, pain pressure threshold and quality of life in Hamstring muscle strain injury 2019-04-09 anticipated 32 Complete https://irct.ir/trial/43228 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple Randomization: Patients will be assigned a number according to the order of selection and will be divided into two treatment groups by sortition. The first pulled out number would be assigned to the treatment group 1 and the subsequent numbers would be assigned treatment group 2, respectively. Stratified randomization is based on gender and Body Mass Index (BMI), Blinding description: Only the Participants of the Study will be blinded. Patients would be assigned in two groups randomly. Difference of two groups is in intensity of Tecar therapy(High frequency electromagnetic currents), as in control group , Sham therapy (with zero intensity) would be applied and intensity of device in treatment group would be 20-30 percent. Patients will not be aware of intensity of Tecar device. 3 Muscle Strain Injury. Intervention 1: Intervention group: Patients in this group receive Capacitive Tecar therapy ( High frequency electromagnetic currents), with intensity of 20-30 percent for 15 minutes in injury site of hamstring muscle ( Posterior area of thigh), then they are treated with 25 minutes of TENS ( AN analgesic electric currents with frequency of 120 Hz) , after that patients receive 3-5 minutes of Pulsed Ultrasound therapy with duty cycle of 50-80 percent . After 5 treatment sessions, Isometric and stretching hamstring muscle exercises will be added to the treatment program ( treatment program includes 10 sessions in which 4 sessions would be in first week and 6 sessions in second and third week too). Intervention 2: Control group: Patients in this group are treated with 25 minutes of TENS ( AN analgesic electric currents with frequency of 120 Hz) , after that patients receive 3-5 minutes of Pulsed Ultrasound therapy with duty cycle of 50-80 percent. Capacitive Tecar therapy ( High frequency electromagnetic currents) in this group will be used as Sham therapy (with zero intensity) for 15 minutes in injury site of hamstring muscle ( Posterior area of thigh). After 5 treatment sessions, Isometric and stretching hamstring muscle exercises will be added to the treatment program ( treatment program includes 10 sessions in which 4 sessions would be in first week and 6 sessions in second and third week too). 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 No more information
public Seyed Ali Adabi
No.4, Honarmand alley , Shahid beheshti Ave, Varamin Town , Tehran
Varamin Iran (Islamic Republic of) 3371843433 +98 21 3624 7842 aliadabi_msc@yahoo.com Shahid Beheshti University of Medical Sciences scientific Khosro Khademi-Kalantari
School of Rehabilitation of Shahid Beheshti University of Medical Science, Damavand Ave, Emam Hossein Sq
Tehran Iran (Islamic Republic of) 1616913111 +98 21 7756 1721 k_khademi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age 18-40 Structural hamstring muscle strain injuries ( indirect muscle injuries) Existence of muscle haematoma which is confirmed by imaging test Patients with pain intensity of more than 3, in Visual Analog Scale Absence of history of surgery or metal implantation in lower limb, especially in posterior area of hip and thigh Not using Analgesic and Anticoagulant drugs 18 years 40 years Both Pregnancy Existence of tumor or malignant tissue Having electronic implanted device such as pace maker Open infected wounds Treated with radiotherapy in last 6 month Cardiovascular disorders Tuberclosis Unreliable patients S76.311A Strain of muscle, fascia and tendon of the posterior muscle group at thigh level Rehabilitation Rehabilitation Intervention group: Patients in this group receive Capacitive Tecar therapy ( High frequency electromagnetic currents), with intensity of 20-30 percent for 15 minutes in injury site of hamstring muscle ( Posterior area of thigh), then they are treated with 25 minutes of TENS ( AN analgesic electric currents with frequency of 120 Hz) , after that patients receive 3-5 minutes of Pulsed Ultrasound therapy with duty cycle of 50-80 percent . After 5 treatment sessions, Isometric and stretching hamstring muscle exercises will be added to the treatment program ( treatment program includes 10 sessions in which 4 sessions would be in first week and 6 sessions in second and third week too). Control group: Patients in this group are treated with 25 minutes of TENS ( AN analgesic electric currents with frequency of 120 Hz) , after that patients receive 3-5 minutes of Pulsed Ultrasound therapy with duty cycle of 50-80 percent. Capacitive Tecar therapy ( High frequency electromagnetic currents) in this group will be used as Sham therapy (with zero intensity) for 15 minutes in injury site of hamstring muscle ( Posterior area of thigh). After 5 treatment sessions, Isometric and stretching hamstring muscle exercises will be added to the treatment program ( treatment program includes 10 sessions in which 4 sessions would be in first week and 6 sessions in second and third week too). Area size of muscle haematoma. Timepoint: Before intervention, After 10 treatment sessions, After 1 and 2 month follow up. Method of measurement: Ultrasonography imaging. Pain intensity. Timepoint: Before intervention, After 10 treatment sessions, After 1 and 2 month follow up. Method of measurement: Based on Visual Analog Scale. Pain Pressure Threshold. Timepoint: Before intervention, After 10 treatment sessions, After 1 and 2 month follow up. Method of measurement: By using Algometer device. Quality of life. Timepoint: Before intervention, After 10 treatment sessions, After 1 and 2 month follow up. Method of measurement: Using SF-36 questionnaire. Shahid Beheshti University of Medical Science Approved 2019-01-15 Ethics committee of Shahid Beheshti University of Medical Science 3rd Floor, Medical Faculty, Next to the Taleghani hospital, Evin, Shahid Chamran highway Tehran Tehran Iran (Islamic Republic of)