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IRCT20211012052742N1 IRCT 2021-10-19 Shahid Beheshti University of Medical Sciences The effect of laser therapy on the treatment of partial tear of the supraspinatus tendon A comparative study of the effects of low and high power laser therapy in partial tear of the supraspinatus tendon with use of ultrasonography in 20 to 40 years old subjects with shoulder pain. 2021-10-30 anticipated 40 Complete https://irct.ir/trial/59301 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to maintain the balance of the number of samples in the two groups and the homogeneity of the samples in the groups, we first divide the patients into four homogeneous classes based on age, sex and location of injury. Then, using the permutation block method, patients are randomly assigned to two treatment groups, Blinding description: Blinding will be done for the participant, evaluator and data analyzer. Patients will be randomly divided into two groups. Low power and high power laser will be used in the intervention. Patients will not know which treatment group they are in. The evaluation is also performed by a person who is not aware of the patients in each group. Finally, we provide the groups to the statistical analyzer as a blind. 3 partial tear of supraspinatus tendon. Intervention 1: Intervention group:Intervention group: At the beginning of the treatment session, people undergoing cold therapy were placed on the shoulder area for 10 to 15 minutes using an ice pack. Then, in the first group, citing the World Laser Therapy Association (WALT) on the properties of the most effective low-power laser parameters in supraspinatus tendinopathy, under low-power IR laser therapy with a wavelength of 810 nm are significant. According to the proposed WALT protocol, the laser is applied at 2 to 3 points at the site of supraspinatus muscle tendon insertion and the former acromial space, with a high energy content of 4 gels per square meter, and generally 12 joules of energy during treatment. The patient's position is sitting and the hand is in the adduction position during the laser application. Pendulum exercises and range of motion improvements from the initial sessions, and isometric strengthening exercises from the fifth session, were added to the treatment program. in order to observe safety during laser treatment, although the risk of eye injury is small, precautions for using the laser are observed. Intervention 2: Intervention group:Intervention group: At the beginning of the treatment session, people undergoing cryotherapy are placed on the shoulder region for 10 to 15 minutes using an ice pack. In this group, a laser with a power of 8 watts, energy of 12 joules per square centimeter and total energy of 10,000 joules will be used for about 15 minutes. The percussion of each pulse will be 150 microseconds and the frequency of 30 Hz in the first and third phases and the frequency of 25-25 Hz in the second phase will be used in an area of ​​25 cm2 during the three phases. The initial phase is applied in front of the shoulder joint line, with 850 mJ of energy per shot and at a frequency of 30 Hz. Total energy applied in this phase is equal to 4000 joules. In the second phase, the energy of each pulse is equal to 350 mJ and with a frequency of 20-25 Hz in front and behind the shoulder joint line. The total energy of this phase is equal to 4000 joules. In the third phase, which is applied in the same place as the first phase as well as the deltoid muscle areas, a total energy of 2000 joules is radiated. In general, the time required for laser treatment in all three phases of treatment will be about 15 minutes. And how to use the laser is rapid manual scanning. A spacer with a diameter of 35 mm will also be used to ensure a constant distance between the applicator and the skin during laser treatment. The patient's position during the laser application is sitting with the affected hand in the adduction position. Pendulum exercises and range of motion improvements from the initial sessions, and isometric strengthening exercises from the fifth session are added to the treatment program. in order to observe safety during laser treatment, although the risk of eye injury is small, precautions for using the laser are observed. 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 َAli Khoshdel
No. 27, West zayande rod Ave, North shirazi Ave, Mollasadre Ave, vanak square
Tehran Iran (Islamic Republic of) 1991613651 +98 58 3224 4488 alikhoshdel97@yahooo.com Shahid Beheshti University of Medical Sciences scientific Abbas Rahimi
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 alikhoshdel97@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age 20 to 40 years With partial tear of Grade 1 and 2 Neer classification in supraspinatus tendon, with or without tearing in other rotator cuff tendons Has partial tear of Grade 1 and 2 that has been confirmed by MRI Positive at least two specific jobe supraspinatus test, Neer and hawkin kennedy Partial tear of the supraspinatus muscle tendon with pain in the shoulder area for at least 3 months and up to one year. Patients with a pain score of 5 or higher as determined by the visual analogue scale. 20 years 40 years Both Full thickness tear in the supraspinatus tendon or Massive rupture in other rotator cuff tendons History of surgery and implants in the shoulder area History of steroid injection in the shoulder joint during the last six months Rheumatoid arthritis Diabetes Neurological disorders Hook-shaped acromion Cases such as tumor, pregnancy, malignant tissue, infection, heat disturbance and people who have undergone radiotherapy in the last 6 months Rehabilitation Rehabilitation Intervention group:Intervention group: At the beginning of the treatment session, people undergoing cold therapy were placed on the shoulder area for 10 to 15 minutes using an ice pack. Then, in the first group, citing the World Laser Therapy Association (WALT) on the properties of the most effective low-power laser parameters in supraspinatus tendinopathy, under low-power IR laser therapy with a wavelength of 810 nm are significant. According to the proposed WALT protocol, the laser is applied at 2 to 3 points at the site of supraspinatus muscle tendon insertion and the former acromial space, with a high energy content of 4 gels per square meter, and generally 12 joules of energy during treatment. The patient's position is sitting and the hand is in the adduction position during the laser application. Pendulum exercises and range of motion improvements from the initial sessions, and isometric strengthening exercises from the fifth session, were added to the treatment program. in order to observe safety during laser treatment, although the risk of eye injury is small, precautions for using the laser are observed. Intervention group:Intervention group: At the beginning of the treatment session, people undergoing cryotherapy are placed on the shoulder region for 10 to 15 minutes using an ice pack. In this group, a laser with a power of 8 watts, energy of 12 joules per square centimeter and total energy of 10,000 joules will be used for about 15 minutes. The percussion of each pulse will be 150 microseconds and the frequency of 30 Hz in the first and third phases and the frequency of 25-25 Hz in the second phase will be used in an area of ​​25 cm2 during the three phases. The initial phase is applied in front of the shoulder joint line, with 850 mJ of energy per shot and at a frequency of 30 Hz. Total energy applied in this phase is equal to 4000 joules. In the second phase, the energy of each pulse is equal to 350 mJ and with a frequency of 20-25 Hz in front and behind the shoulder joint line. The total energy of this phase is equal to 4000 joules. In the third phase, which is applied in the same place as the first phase as well as the deltoid muscle areas, a total energy of 2000 joules is radiated. In general, the time required for laser treatment in all three phases of treatment will be about 15 minutes. And how to use the laser is rapid manual scanning. A spacer with a diameter of 35 mm will also be used to ensure a constant distance between the applicator and the skin during laser treatment. The patient's position during the laser application is sitting with the affected hand in the adduction position. Pendulum exercises and range of motion improvements from the initial sessions, and isometric strengthening exercises from the fifth session are added to the treatment program. in order to observe safety during laser treatment, although the risk of eye injury is small, precautions for using the laser are observed. Supraspinatus tendon thickness, Echogenicity of supraspinatus tendon. Timepoint: Before intervention, after 10 treatment sessions, eight weeks after the end of the treatment sessions follow up. Method of measurement: Ultrasonography imaging. Pain intensity. Timepoint: Before intervention, after 10 treatment sessions, eight weeks after the end of the treatment sessions follow up. Method of measurement: Based on visual analogue scale. Shoulder abduction and adduction rang of motion. Timepoint: Before intervention, after 10 treatment sessions, eight weeks after the end of the treatment sessions follow up. Method of measurement: Using full circle goniometery. Shoulder flexion and extension rang of motion. Timepoint: Before intervention, after 10 treatment sessions, eight weeks after the end of the treatment sessions follow up. Method of measurement: Using full circle goniometery. Shoulder internal and external rotation rang of motion. Timepoint: Before intervention, after 10 treatment sessions, eight weeks after the end of the treatment sessions follow up. Method of measurement: Using full circle goniometery. Shoulder pain and disability. Timepoint: Before intervention, after 10 treatment sessions, eight weeks after the end of the treatment sessions follow up. Method of measurement: Using Shoulder pain and Disability index questionnaire. Shahid Beheshti University of Medical Sciences Approved 2021-10-11 Ethics committee of Shahid Beheshti University of Medical Sciences No. 7, west zayande rod Ave, north shirazi Ave, mollasadra Ave, vanak square Tehran Tehran Iran (Islamic Republic of)