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IRCT20140708018409N3 IRCT 2021-08-23 Mazandaran University of Medical Sciences The effect of microcurrent device and exercise therapy in the treatment of patients with Tennis Elbow disease Comparison effectiveness of microcurrent and exercise therapy on the pain and function in patients with Lateral Epicondylitis(Tennis Elbow disease) 2021-08-23 anticipated 60 Complete https://irct.ir/trial/54109 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Clinical trial without control group, with parallel groups, one-way blind, randomized, Randomization description: There are two envelopes with names A and B, including microcurrent and exercise therapy group, inside the container and the patient chooses one. The selected envelope is then inserted into the container and the next patient selects one again, Blinding description: Considering that the patient knows in which group (exercise therapy or microcurrent therapy ) but the evaluator (supervisors) do not know which patient is in which group and all follow-ups are done by the sports medicine assistant and the evaluator only reviews the results It deals with questionnaires and recorded values of manual dynamometer, so this study is one-way blind. N/A Lateral Epicondylitis. Intervention 1: Intervention group1:Exercise therapy:In this study, exercise therapy protocol was designed in a 6-week period of exercise to strengthen the elbow muscles focusing on the extensor muscles of the forearm involved in the pathology of lateral epicondylitis.Exercise sessions for 6 weeks 3 sessions per week according to the patient's tolerance based on the VAS scale are performed under the supervision of a sports medicine assistant at the clinic.Interventions including range of motion exercises, isometric, isotonic and eccentric exercises can be performed in three sets of 15 repetitions according to the patient's tolerance up to the experience of mild pain (4: VAS). Rest between sets will be 1-2 minutes.If the patient mentions debilitating pain (VAS: 8), the exercise is stopped and its intensity is recorded and it is performed with less intensity in the next sessions.When the patient reaches VAS: 0 in painless exercises, the intensity of the exercises is improved by using weights up to half a kilogram.Stretching exercises are performed in the form of static stretching performed by the patient him/herself with the support of the other hand. 6 stretches divided into 2 sets of 3 stretches are done at the beginning and end of exercise therapy with a time of 30 to 45 seconds of stretching and 30 seconds of rest between stretches. Intervention 2: Intervention group 2: In this study,microcurrent interventionn by NU-TEK MT8000 COMBO STIMULATOR portable microcurrent device made in China for 6 weeks and 3 sessions of 15 minutes every week under 70 μA current at the origin of the extensor muscles in the external epicondyle of the hand will be done. Yes - There is a plan to make this available What will be shared: results of statistical analysis and its analysis When: Start of access 12 months after printing results To whom: Health researchers Conditions: view data Where to obtain: corresponding author How to obtain: About 2 months Comments:
public Gholamreza Partovi
Emam Khomeyni Hospital, Amir Mazandarani Ave
Sari Iran (Islamic Republic of) 4816633131 +98 11 3336 6552 ghpartovi@mazums.ac.ir Mazandaran University of Medical Sciences scientific Gholamreza Partovi
Emam Khomeyni Hospital, Amir Mazandarani Ave
Sari Iran (Islamic Republic of) 4816633131 +98 11 3336 6552 ghpartovi@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) All patients with Lateral Epicondylitis in the age range of 18 to 60 years who do not have criteria for not entering the interventions 18 years 60 years Both Any contraindications to the use of microcurrent therapy, including: epilepsy, diabetes, immune system disorders, cancer, melanoma, metal implants (plates, pins, and screws) at the treatment site, open wounds, pacemaker, phlebitis, thrombosis , embolism, varicose veins and pregnancy Any history of shoulder or elbow fractures or history of dislocations in these areas during the past year Any history of shoulder and elbow surgery during the last six months Any phobias about treatment and suffer from chronic psychiatric disorders Any allergies and contraindications to the use of NSAIDs Any history of cervical discopathy confirmed by imaging and sensory-motor involvement symptoms (paresthesia) in the upper limb M77.1 Lateral epicondylitis Treatment - Devices Treatment - Devices Intervention group1:Exercise therapy:In this study, exercise therapy protocol was designed in a 6-week period of exercise to strengthen the elbow muscles focusing on the extensor muscles of the forearm involved in the pathology of lateral epicondylitis.Exercise sessions for 6 weeks 3 sessions per week according to the patient's tolerance based on the VAS scale are performed under the supervision of a sports medicine assistant at the clinic.Interventions including range of motion exercises, isometric, isotonic and eccentric exercises can be performed in three sets of 15 repetitions according to the patient's tolerance up to the experience of mild pain (4: VAS). Rest between sets will be 1-2 minutes.If the patient mentions debilitating pain (VAS: 8), the exercise is stopped and its intensity is recorded and it is performed with less intensity in the next sessions.When the patient reaches VAS: 0 in painless exercises, the intensity of the exercises is improved by using weights up to half a kilogram.Stretching exercises are performed in the form of static stretching performed by the patient him/herself with the support of the other hand. 6 stretches divided into 2 sets of 3 stretches are done at the beginning and end of exercise therapy with a time of 30 to 45 seconds of stretching and 30 seconds of rest between stretches. Intervention group 2: In this study,microcurrent interventionn by NU-TEK MT8000 COMBO STIMULATOR portable microcurrent device made in China for 6 weeks and 3 sessions of 15 minutes every week under 70 μA current at the origin of the extensor muscles in the external epicondyle of the hand will be done. Patient-Rated Tennis Elbow Evaluation questionnaire (PRTEE). Timepoint: Before the beginning and end of the intervention (sixth week) and 12 weeks after the end of the intervention. Method of measurement: Measurements are performed based on the values obtained from PRTEE questionnaire. Visual Analog Scale For Pain(VAS). Timepoint: Before the beginning and end of the intervention (sixth week) and 12 weeks after the end of the intervention. Method of measurement: Measurements are performed based on the values obtained from VAS questionnaire. Handheld dynamometer. Timepoint: Before the beginning and end of the intervention (sixth week) and 12 weeks after the end of the intervention. Method of measurement: Measurements are performed based on the values obtained from Handheld dynamometer . Mazandaran University of Medical Sciences Approved 2021-01-24 Ethics committee of Mazandaran University of Medical Sciences Vice chancellor for research Mazandaran University of Medical Sciences, Moalem Square, Moalem Street Sari Mazandaran Iran (Islamic Republic of)