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IRCT20201010048978N1 IRCT 2021-04-20 Mashhad University of Medical Sciences The comparative effect of two methods of rehabilitation in patients after arthroscopic shoulder rotator cuff tendon repair. Comparison of the short-term effects of routine physiotherapy and physiotherapy with emphasis on the scapulothoracic joint on pain, range of motion, functional ability and quality of life after arthroscopic shoulder rotator cuff tendon repair. 2020-09-13 anticipated 30 Complete https://irct.ir/trial/51553 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In the present study, randomization is performed by an independent therapist using the block randomization method. In order to assign 15 patients in each group equally, we will use numbers between 1 and 30 for randomization, with even numbers representing the intervention group and odd numbers representing the control group. The reason for performing block randomization is to have the same number of samples in each group. The numbers are written on paper and placed in opaque sealed envelopes, and stamped. Those who meet the inclusion criteria are asked to pick up an envelope, and depending on whether the number in the envelope is even or odd, the patient will be randomly assigned, Blinding description: The trial assessor and statistician were blinded to the treatment allocation throughout the study period. N/A Complete rotator cuff tear or rupture not specified as traumatic. Intervention 1: Intervention group: Postoperative information and intervention if eligible to enter the study after 2 weeks of a rehabilitation program. Physiotherapy treatment in both groups was 21 sessions in 7 consecutive weeks and three sessions per week. Besides the conventional physiotherapy program, this program includes manual techniques to help the scapula and thoracic spine, training the correct position of the scapula at rest, movement control and strengthening of the lower, middle, and serratus trapezius, along with exercises to facilitate multifunctional deep sensation. Intervention 2: Control group: After surgery and evaluation, patients will start a rehabilitation program after 2 weeks if they are eligible to enter the study. Physiotherapy treatment is 21 sessions that will be done in 7 consecutive weeks and three sessions per week. This rehabilitation program includes: pendulum exercises, stretching techniques, manual techniques including manual treatment of glenohumeral joint (lower and posterior glide of the humerus) and rotator cuff muscle strengthening program. Therapeutic modalities are also used in each session. Yes - There is a plan to make this available What will be shared: All reports will be reported in one research paper.Raw data will be delivered to researchers for meta analysis. When: starting 6months after publication. To whom: For researchers Conditions: Only for meta-analysis Where to obtain: marzie.rezaee73@gmail.com How to obtain: The response will be sent within 3months after considering the researcher`s request. Comments:
public Marzie Rezaee
Azadi square, East door of Ferdowsi University of Mahhad, University campus, Faculty of paramedical sciences
Mashhad Iran (Islamic Republic of) 9177948964 +98 51 3513 7115 Marzie.rezaee73@gmail.com Mashhad University of Medical Sciences scientific Marzie Rezaee
Azadi square,East door of Ferdowsi university of Mashhad,university campus,Faculty of paramedical sciences
Mashhad Iran (Islamic Republic of) 9177948964 +98 51 3513 7115 Marzie.rezaee73@gmail.com Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients aged 30-75 years The origin of the rupture should be progressive damage The size of the rupture is small and medium (= <3 cm) Patients with complete rupture of the rotator-cuff muscles except subscapularis Since this operation is usually performed in conjunction with other restorative procedures such as subacromial decompression and distal clavicle resection; to increase the generalizability to the community in this study, patients can be accompanied by these operations. 30 years 75 years Both Any complication in the shoulder girdle area such as arthritis of the shoulder joint or destructive joint disease as well as SLAP and Bankart surgery Traumatic tears that result from direct trauma or injury and tears larger than 3 cm Existence of neurological disorders such as disorders Neurological with sensory and muscular problems Radicular pain from the neck or chest (Increased/developed shoulder symptoms with active or inactive neck movement) History of fracture, dislocation or shoulder complex surgery History of RSD History of recurrent dislocation or joint instability Shoulder in the last 3 months Symptoms of preoperative capsular adhesion characterized by a loss of more than 50% of inactive range of motion compared to the non-involved side in at least two shoulder movements S46.0 Injury of muscle(s) and tendon(s) of the rotator cuff of shoulder Rehabilitation Rehabilitation Intervention group: Postoperative information and intervention if eligible to enter the study after 2 weeks of a rehabilitation program. Physiotherapy treatment in both groups was 21 sessions in 7 consecutive weeks and three sessions per week. Besides the conventional physiotherapy program, this program includes manual techniques to help the scapula and thoracic spine, training the correct position of the scapula at rest, movement control and strengthening of the lower, middle, and serratus trapezius, along with exercises to facilitate multifunctional deep sensation. Control group: After surgery and evaluation, patients will start a rehabilitation program after 2 weeks if they are eligible to enter the study. Physiotherapy treatment is 21 sessions that will be done in 7 consecutive weeks and three sessions per week. This rehabilitation program includes: pendulum exercises, stretching techniques, manual techniques including manual treatment of glenohumeral joint (lower and posterior glide of the humerus) and rotator cuff muscle strengthening program. Therapeutic modalities are also used in each session. Pain intensity. Timepoint: Before the start of the treatment plan/after the completion of the treatment plan. Method of measurement: Visual Analogue Scale (VAS). Range of motion. Timepoint: Before the start of the treatment plan (two weeks after the surgery) and after the completion of the treatment plan (9 weeks after the surgery). Method of measurement: Goniometer. Disability. Timepoint: Before the start of the treatment plan (two weeks after the surgery) and after the completion of the treatment plan (9 weeks after the surgery). Method of measurement: SPADI questionnaire. The quality of life. Timepoint: Before the start of the treatment plan (two weeks after the surgery) and after the completion of the treatment plan (9 weeks after the surgery). Method of measurement: Western Ontario Rotator cuff index questionnaire(Worc). The effectiveness of treatment. Timepoint: Before the start of the treatment plan (two weeks after the surgery) and after the completion of the treatment plan (9 weeks after the surgery). Method of measurement: Global Rating of Scale(GRC) questionnaire. Functional level. Timepoint: Before the start of the treatment plan (two weeks after the surgery) and after the completion of the treatment plan (9 weeks after the surgery). Method of measurement: ASES questionnaire. Mashhad University of Medical Sciences Approved 2020-09-12 The Ethics Committee of Mashhad University of Medical Sciences Opposite University Street 18, University street Mashhad Razavi Khorasan Iran (Islamic Republic of)