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IRCT20140810018754N10 IRCT 2019-11-29 Iran University of Medical Sciences The effect of high power laser in chronic lateral epicondylitis The effect of high power laser with exercise versus sham high power laser with exercise versus high power laser on pain, grip strength and function in patients with chronic lateral epicondylitis. 2019-11-20 anticipated 75 Complete https://irct.ir/trial/43091 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Method: simple - unit: personal- by using sealed envelope Participants will be randomly assigned to 3 groups(intervention NO1.; intervention NO2. and control groups) by drawing a sealed envelope in which the number of one of the groups is written from a box. After completing a group it`s envelope will be put away, Blinding description: The participants will be unaware of classification and to prevent of the participants communication, timing will arrange carefully. In the control group, the Laser set will be off. Assessor will be kept unaware and will be asked to do just evaluation and abstrain of any answer and question. N/A Chronic Lateral Epicondylitis. Intervention 1: In the intervention group NO.1, intervention includes high power laser therapy and exercise. The laser parameters are: power 7 W.; energy dose 10 j/cm2; duty cycle 50%. In the first session that is a warm up the laser dose will be 5 j/cm2 and in the next ten sessions the laser dose will be 10 j/cm2. Subjects will be evaluated before the warm up; at the end of the first; fifth; tenth sessions and after 3 months follow up. During the each session, in sitting position, elbow in extension and forearm in pronation after safety precautions the treatment area will be demarcated then the laser probe will be moved along the long axis and transverse to the tendon. Exercise includes static stretching followed by eccentric exercise of wrist extensors. Stretching exercise will be performed in seated position with elbow extension and forearm pronation and wrist flexion with ulnar deviation.Stretch force will be applied by therapist according to the participant tolerance for 30 to 45 seconds and 3 times before and 3 times after eccentric exercise with 30 seconds rest between each stretch. Eccentric exercise will be performed in the seated position with elbow extension, forearm pronation and maximum wrist extension. Then the participant slowly will lower the wrist in to the flexion for a count of 30. Using the contralateral hand to return to the started position. 3 set of 10 repetition will be performed during each session with a one minute rest interval between each set for 10 sessions every other day. Intervention 2: Intervention group NO.2:This group receives high power laser( with the protocol as mentioned in group NO.1( laser power 5W; laser dosage 5J/CM2 in the warm up session and 10J/cm2 in the 10 treatment sessions )without exercises. Due to ethical considerations subjects will be offered the exercise after 3 months follow up. Intervention 3: Control group: In this group the laser unit will be off and the exercise program will be performed as the program in the intervention group NO.1. Due to ethical considerations the subjects will be offered the true treatment after 3 month follow up. Yes - There is a plan to make this available What will be shared: All data or results of the present study will be presented in an article or some articles that will be published after completing the study. When: After completing the present study and publishing the resulting article or articles To whom: All researchers in the field of the present study Conditions: With the same goal as the present study and with mention of the present study as the reference. All intellectual property rights of the present study belongs to the Iran University of Medical Sciences. Where to obtain: The corresponding author of the article or articles derived from this study How to obtain: Written request from the author responsible for the present review after the publication of the resulting article or articles. Comments:
public Sarrafzadeh Javad
Physiotherapy department, School of Rehabilitation Sciences, Madadkaran St., Shahnazari St., Madar Squ., Mirdamad St.
Tehran Iran (Islamic Republic of) 1545913487 +98 21 2222 8051 sarrafzadeh.j@iums.ac.ir Iran University of Medical Sciences scientific Dr. Sarrafzadeh Javad
Physiotherapy department, School of Rehabilitation Sciences, Madadkaran St., Shahnazari St., Madar squ., Mirdamad St.
Tehran Iran (Islamic Republic of) 1545913487 +98 21 2222 8051 sarrafzadeh.j@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) History of the symptoms between 3 to 6 months Exacerbating the pain on lateral aspect of elbow by gripping 2 of 3 positive results of Mills-Cozen and Maudsley tests Tenderness with palpation of lateral epicondylitis 35 years 55 years Both Cervical radiculopathy, neuropathy and myelopathy Any type of treatment; drugs, local injections and physiotherapy within the past 3 months History of upper extremity surgical treatment Deformity and fractures of the humerus and elbow joint bones Pregnancy Rheumatic disease Photosensitivity M77.10 Chronic Lateral Epicondylitis Treatment - Other Treatment - Other Treatment - Other In the intervention group NO.1, intervention includes high power laser therapy and exercise. The laser parameters are: power 7 W.; energy dose 10 j/cm2; duty cycle 50%. In the first session that is a warm up the laser dose will be 5 j/cm2 and in the next ten sessions the laser dose will be 10 j/cm2. Subjects will be evaluated before the warm up; at the end of the first; fifth; tenth sessions and after 3 months follow up. During the each session, in sitting position, elbow in extension and forearm in pronation after safety precautions the treatment area will be demarcated then the laser probe will be moved along the long axis and transverse to the tendon. Exercise includes static stretching followed by eccentric exercise of wrist extensors. Stretching exercise will be performed in seated position with elbow extension and forearm pronation and wrist flexion with ulnar deviation.Stretch force will be applied by therapist according to the participant tolerance for 30 to 45 seconds and 3 times before and 3 times after eccentric exercise with 30 seconds rest between each stretch. Eccentric exercise will be performed in the seated position with elbow extension, forearm pronation and maximum wrist extension. Then the participant slowly will lower the wrist in to the flexion for a count of 30. Using the contralateral hand to return to the started position. 3 set of 10 repetition will be performed during each session with a one minute rest interval between each set for 10 sessions every other day. Intervention group NO.2:This group receives high power laser( with the protocol as mentioned in group NO.1( laser power 5W; laser dosage 5J/CM2 in the warm up session and 10J/cm2 in the 10 treatment sessions )without exercises. Due to ethical considerations subjects will be offered the exercise after 3 months follow up. Control group: In this group the laser unit will be off and the exercise program will be performed as the program in the intervention group NO.1. Due to ethical considerations the subjects will be offered the true treatment after 3 month follow up. Pain. Timepoint: Before warm up session ,at the end of the first, fifth, tenth sessions and after 3 months. Method of measurement: VAS=visual analog scale. Hand grip strength. Timepoint: Before warm up session, at the end of first, fifth,tenth,sessions and after 3 months follow up. Method of measurement: Dynamometer. Function. Timepoint: Before warm up session; at the end of first; fifth; tenth sessions and after 3 months follow up. Method of measurement: PRTEE Questionair= Patient Rated Tennis Elbow Evaluation. Iran University of Medical Sciences Approved 2019-09-14 Ethics committee of Iran University of Medical Scienses 5th Floor, Iran University of Medical Science, next to Milad Tower, Hemmat Highway Tehran Tehran Iran (Islamic Republic of)