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IRCT20210214050356N5 IRCT 2022-08-03 Tehran University of Medical Sciences Effects of Laser in Treatment of Ankle Sprain Comparison of the effects of high-intensity laser therapy versus low-level laser therapy on pain, function and range of motion in patients with sub-acute ankle sprain: A randomized controlled trial 2022-08-23 anticipated 36 Complete https://irct.ir/trial/64997 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After the initial evaluation, the patients are randomly placed in one of the three intervention 1, intervention 2 and control groups (randomization method: block of six, unit: cluster). The randomization process will be done by an independent person and each of the numbers assigned to the participants through the software (randomization tool: Random Allocation software with a block of six and equal allocation ratio for three groups), they are placed inside a sealed envelope and the patients receive this envelope from the clinic secretary who is not aware of the evaluation processes and etc, Blinding description: As mentioned above, the study will be double-blinded. In this way, the participants do not know in which group they are. Participants only know that laser are used for them and have no knowledge of the type of laser (high intensity, low- level, and placebo laser in the control group). The data analyzer is also unaware of which study group the data belongs to. But the therapist, who is the one applying the different lasers, assessing the outcome measures, knows the participants' groups. N/A Sprain of ankle. Intervention 1: Intervention group 1: Group 1 (n = 12) will receive high- intensity laser with conventional therapy (Ice, Ultrasound, supervised exercise & home exercises, three sessions in a week for three weeks. Intervention 2: Intervention group 2: Group 2 (n = 12) will receive low- level laser with conventional therapy (Ice, Ultrasound, supervised exercise & home exercises, three sessions in a week for three weeks. Intervention 3: Control group: Group 3 (n = 12) will receive placebo laser and conventional therapy (Ice, Ultrasound, supervised exercise & home exercises, three sessions in a week for three weeks. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified individuals. When: Access period starts 3 months after the articles are published To whom: For researchers working in academic, scientific and hospital institutions Conditions: Researchers working in the field of musculoskeletal physiotherapy and electrotherapy. Where to obtain: Applicants for documentation can contact Dr. Sara Fereydounnia via email. S-fereydounnia@sina.tums.ac.ir How to obtain: Once they have the necessary criteria, the information will be provided to them within a month. Comments:
public Sara Fereydounnia
School of Rehabilitation, Piche- Shemiran, Enghelab Street
Tehran Iran (Islamic Republic of) 1148965111 +98 21 7752 8468 S-fereydounnia@sina.tums.ac.ir Tehran University of Medical Sciences scientific Zinat Ashnagar
School of Rehabilitation, Piche- Shemiran, Enghelab Street
Tehran Iran (Islamic Republic of) 1148965111 +98 21 7753 3939 z-ashnagar@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Age of 18 to 30 years Grade I or II ankle sprain in the prior one to five weeks Pain intensity will be more than 4 at Numeric Pain Rating Scale 4 common clinical tests including palpatory tenderness, anterior drawer test, talar tilt test, and squeeze test will be used to detect the ankle sprain and to exclude other ankle injuries 18 years 30 years Both Ankle sprain Grade III History of recent surgery, trauma and fracture Congenital and acquired deformities of lower limbs History of Cancer or tumors Taking Anticoagulant medication People who will not willing to participate in the study due to any reason. S93.4 Sprain of ankle Rehabilitation Rehabilitation Rehabilitation Intervention group 1: Group 1 (n = 12) will receive high- intensity laser with conventional therapy (Ice, Ultrasound, supervised exercise & home exercises, three sessions in a week for three weeks. Intervention group 2: Group 2 (n = 12) will receive low- level laser with conventional therapy (Ice, Ultrasound, supervised exercise & home exercises, three sessions in a week for three weeks. Control group: Group 3 (n = 12) will receive placebo laser and conventional therapy (Ice, Ultrasound, supervised exercise & home exercises, three sessions in a week for three weeks. Pain. Timepoint: Before intervention- After the last session of intervention. Method of measurement: Numeric Pain Rating Scale. Physical function. Timepoint: Before intervention- After the last session of intervention. Method of measurement: Foot and Ankle Ability Measure. Range of Motion. Timepoint: Before intervention- After the last session of intervention. Method of measurement: Goniometer. Balance. Timepoint: Before intervention- After the last session of intervention. Method of measurement: Y Balance Test. Tehran University of Medical Sciences Approved 2022-07-16 Research Ethics Committees of School of Nursing and Midwifery & Rehabilitation- Tehran University of Vice Chancellor for Research, 6th Floor, Central University Organization, Corner of Ghods St, Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)