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IRCT20200102045987N1 IRCT 2020-03-03 Dezfoul University of Medical Sciences Examining the separate and combined effects of physiotherapy treatment and corticosteroid injection on range of motion and pain in patients with full tickness rotator cuff tear. CSI Examining the separate and combined effects of physiotherapy treatment and corticosteroid injection on range of motion and pain in patients with full tickness rotator cuff tear referring to the specialized clinic in Dezfull city. 2020-02-20 anticipated 96 Complete https://irct.ir/trial/44779 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Supportive, Randomization description: 96 patients are sampled in a randomized block method. They are divided into 3 groups of 33 individuals, as it were, all subset items are calculated based on the 6-person blocks (AABBCC) and they are assigned to each Intervention groups according to the patients’ random blocking. 2-3 Examining the separate and combined effects of physiotherapy treatment and corticosteroid injection on range of motion and pain in patients with full tickness thickness rotator cuff tear. Intervention 1: Intervention group1: The shoulder ROM of 33 patients with rotator cuff tear is first measured by goniometer and DASH questionnaire will be completed by them; then, they will be put under 12 sessions of physiotherapy as massaging, exercises and stretching of rotator cuff and Scapular muscles, Strength exercises and modalities including TENS, Laser and US as twice a week for 6 weeks, each session lasting 45 minutes, including 30 minutes of electrotherapy and 15 minutes of manual therapy. At the end of the physiotherapy sessions, the DASH questionnaire is completed again by the patient and the motor function is checked with a goniometer, and is compared with the pre-intervention; in fact, the control and intervention groups are in common. Intervention 2: Intervention group2: The shoulder ROM of 33 patients with rotator cuff tear is first measured by goniometer and DASH questionnaire will be completed by them; then, they are injected by 80 mg of methylprednisolone and 1 ml of 2% Lidocaine by an orthopaedic physician in two phases within 21 days and 3 weeks after the second injection, DASH questionnaire is completed by the patient and the motor function is checked with a goniometer; and is compared with the pre-intervention; in fact, the control and intervention groups are in common. Intervention 3: Intervention group3: The shoulder ROM of 33 patients with rotator cuff tear is first measured by goniometer and DASH questionnaire will be completed by them; they are injected by 80 mg of methylprednisolone and 1 ml of 2% Lidocaine and after 2 days, they will be put under 6 sessions of physiotherapy, twice a week for 3 weeks, each session lasts 45 minutes including 30 minutes of electrotherapy and 15 minutes of manual therapy by rehabilitation specialist and the second injection will be done again after 6 sessions of physiotherapy at the end of third week, and 6 sessions of physiotherapy will be done twice a week for 3 weeks, each session lasts 45 minutes (the physiotherapy steps are similar to the first group). At the end of the sessions, the DASH questionnaire is completed by the patient and the motor function is checked with a goniometer and is compared with the pre-intervention; in fact, the control and intervention groups are in common. At the end of the study, the data results before and after the intervention of these 3 groups will be compared. Yes - There is a plan to make this available What will be shared: Examining the separate and combined effects of physiotherapy treatment and corticosteroid injection on range of motion and pain in patients with complete rotator cuff tear referring to the specialized clinic in Dezfull city. When: 2021/3/21 to 2021/9/21 To whom: Enthusisasts the subject under study Conditions: In case of obtain written consent Where to obtain: project managers How to obtain: Send a written request letter to project managers Comments:
public Shaahin Hajivandi
No.38, payervan Ave., Andimeshk Town
Andimeshk Iran (Islamic Republic of) 6484113532 +98 61 4264 0419 atousadachek@gmail.com Dezfoul University of Medical Sciences scientific Shaahin Hajivandi
No.38, payervan Ave., Andimeshk Town
Andimeshk Iran (Islamic Republic of) 6484113532 +98 61 4264 0419 atousadachek@gmail.com Dezfoul University of Medical Sciences Iran (Islamic Republic of) Patients with degenerative rotator cuff tear confirmed by MRI and clinical examination. 30_70 years old No metastasis or cancer No concurrent shoulder disease like fracture and infection Patient collaborations and having informed consent No severe cervical radiculopathy Full consciousness No therapeutic intervention by the persons not presenting in the plan No trauma during treatment No contraindication of corticosteroid injection like sensitivity to these drugs and symptoms of skin infection at the injection site 30 years 70 years Both Over than 70 years old Existence of Metastasis or cancer Existence of concurrent shoulder disease such as infection, fracture and tumor Non-cooperation of the patients Impaired consciousness in patients Existence of severe cervical radiculopathy Therapeutic intervention by the persons not presenting in the plan Trauma during treatment Contraindications of corticosteroid injection such as sensitivity to these drugs and symptoms of skin infection at the injection site Tears caused by acute trauma Lifestyle Lifestyle Lifestyle Intervention group1: The shoulder ROM of 33 patients with rotator cuff tear is first measured by goniometer and DASH questionnaire will be completed by them; then, they will be put under 12 sessions of physiotherapy as massaging, exercises and stretching of rotator cuff and Scapular muscles, Strength exercises and modalities including TENS, Laser and US as twice a week for 6 weeks, each session lasting 45 minutes, including 30 minutes of electrotherapy and 15 minutes of manual therapy. At the end of the physiotherapy sessions, the DASH questionnaire is completed again by the patient and the motor function is checked with a goniometer, and is compared with the pre-intervention; in fact, the control and intervention groups are in common. Intervention group2: The shoulder ROM of 33 patients with rotator cuff tear is first measured by goniometer and DASH questionnaire will be completed by them; then, they are injected by 80 mg of methylprednisolone and 1 ml of 2% Lidocaine by an orthopaedic physician in two phases within 21 days and 3 weeks after the second injection, DASH questionnaire is completed by the patient and the motor function is checked with a goniometer; and is compared with the pre-intervention; in fact, the control and intervention groups are in common. Intervention group3: The shoulder ROM of 33 patients with rotator cuff tear is first measured by goniometer and DASH questionnaire will be completed by them; they are injected by 80 mg of methylprednisolone and 1 ml of 2% Lidocaine and after 2 days, they will be put under 6 sessions of physiotherapy, twice a week for 3 weeks, each session lasts 45 minutes including 30 minutes of electrotherapy and 15 minutes of manual therapy by rehabilitation specialist and the second injection will be done again after 6 sessions of physiotherapy at the end of third week, and 6 sessions of physiotherapy will be done twice a week for 3 weeks, each session lasts 45 minutes (the physiotherapy steps are similar to the first group). At the end of the sessions, the DASH questionnaire is completed by the patient and the motor function is checked with a goniometer and is compared with the pre-intervention; in fact, the control and intervention groups are in common. At the end of the study, the data results before and after the intervention of these 3 groups will be compared. Pain score of patients on the criterion VAS(Visual analoge scale). Timepoint: The shoulder ROM in patients at the beginning of the study (before intervention) and at the end of physiotherapy sessions and one month after the last physiotherapy session. Method of measurement: Questionnaire DASH. Shoulder Range of motion. Timepoint: The shoulder ROM in patients at the beginning of the study (before intervention) and at the end of physiotherapy sessions and one month after the last physiotherapy session. Method of measurement: Goniametr. Dezfoul University of Medical Sciences Approved 2019-12-28 Ethics committee of dezful University of Medical Sciences No.37, payervan Ave., Andimeshk Town Andimeshk Khouzestan Iran (Islamic Republic of)