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IRCT20200326046866N1 IRCT 2020-10-06 Tabriz University of Medical Sciences The effectiveness of Exercise therapy and complementary shock wave therapy on improving the situation in patients with frozen shoulder ESWT The effectiveness of Exercise therapy with and without complementary shock wave therapy on the pain and range of motion in patients with frozen shoulder 2020-10-01 anticipated 50 Complete https://irct.ir/trial/46822 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Other design features: In the control group, patients will receive exercise therapy for up to six weeks. but In the intervention group, the treatment protocol is performed in such a way that patients do exercise therapy for up to three weeks. From week three onward, they will be treated with exercise therapy (on days when they do not exercise therapy) for up to six weeks with a shock wave, Randomization description: Patients are randomly divided into two groups A and B using computer randomization (using Excel program). This arrangement is written in envelopes and Put in a box and When selecting patients, they are treated according to this sequence, Blinding description: Patients ,investigator and data analyst will be blind to the study But consequence assessor and data supervisor committee will be aware of study. Patients: shock wave probe are gonna applied in both groups But in the control group it will be in off mode. Investigator and data analyst: they are going to analyze the data without any information about patients groups. N/A Frozen Shoulder. Intervention 1: Intervention group: It will use a shock wave therapy device with the specifications of ROSETTA the CR technology made in South Korea. The treatment protocol will be such that the person is sitting in the shock wave group with the shoulder away from the center with the elbow curve at an angle of 45 degrees and the arm at rest. Shock waves will shine on the sensitive points near the Rotator cuff joint in the small protrusion of the bone, below the tip of the shoulder. Shock wave will be performed once every five days for 4 consecutive weeks and in each session 3000 shocks with a frequency of 10 Hz. Intervention 2: Control group: An exercise therapy program is offered for six weeks and three sessions each week (between 45 and 60 minutes) that From week three onward, they receive the same treatment as the experimental group for up to six weeks, While the shock wave device is off and is placed on the patient's shoulder at the same time. Yes - There is a plan to make this available What will be shared: In case of journal editor requesting When: After submission until article publication To whom: Editors and reviewers Conditions: For the next studies Where to obtain: Corresponding author How to obtain: Writing a Email Comments:
public Dr Alireza Rouhani
5Floor, Hakim Building, New Pastour Ave
Tabriz Iran (Islamic Republic of) 515 774 4897 +98 41 3557 9744 rouhani.m.d@gmail.com Tabriz University of Medical Sciences scientific Dr Alireza Rouhani
5Floor, Hakim Building, New Pastour Ave
Tabriz Iran (Islamic Republic of) 515 774 4897 +98 41 3557 9744 rouhani.m.d@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) with symptoms and signs of frozen shoulder disease for at least 3 months with Frozen shoulder disease according to orthopedic specialist diagnosis Significant loss of shoulder joint mobility in active and passive motion Nocturnal pain and daily activity in the shoulder joint Age range 40 to 60 years 40 years 60 years Both history of illness and underlying injuries affecting the frozen shoulder such as fracture, dislocation, joint instability history of neuromuscular skeletal disease Rotator Cuff Muscle Tear History of previous surgeries History of taking any medication or painkiller and Use of therapeutic measures for frozen shoulder problems M75.0 Adhesive capsulitis of shoulder Rehabilitation Rehabilitation Intervention group: It will use a shock wave therapy device with the specifications of ROSETTA the CR technology made in South Korea. The treatment protocol will be such that the person is sitting in the shock wave group with the shoulder away from the center with the elbow curve at an angle of 45 degrees and the arm at rest. Shock waves will shine on the sensitive points near the Rotator cuff joint in the small protrusion of the bone, below the tip of the shoulder. Shock wave will be performed once every five days for 4 consecutive weeks and in each session 3000 shocks with a frequency of 10 Hz. Control group: An exercise therapy program is offered for six weeks and three sessions each week (between 45 and 60 minutes) that From week three onward, they receive the same treatment as the experimental group for up to six weeks, While the shock wave device is off and is placed on the patient's shoulder at the same time. Improve pain. Timepoint: Before starting the intervention- Six weeks after the intervention. Method of measurement: Visual Analogue Scale - Constant Murley Score. Improve range of motion. Timepoint: Before starting the intervention- Six weeks after the intervention. Method of measurement: Shoulder Pain And Disability Index. Tabriz University of Medical Sciences Approved 2020-09-14 Ethics Committee of Tabriz Universityy of Medical Sciences Ashpaz bashi Restaurant, front of Tareh Bar Square, Sheikh Shaltout Blvd urmia West Azarbaijan Iran (Islamic Republic of)