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IRCT20240313061278N1 IRCT 2024-04-03 Semnan University of Medical Sciences The effect of electromyographic biofeedback on the electromyographic activity of the shoulder girdle muscles in primary impingement syndrome To compare the shoulder girdle exercises with and without electromyographic biofeedback on the electromyography activity of the shoulder girdle muscles in individuals with primary impingement syndrome: A randomized clinical trial 2024-04-20 anticipated 45 Complete https://irct.ir/trial/76112 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The sample size in each group is 15 people (45 people in total). Permuted block randomization is used for randomization. For this, we use blocks of six in the following order. In each block, a means the intervention group (EMG biofeedback with exercise and routine physiotherapy), b (exercise therapy along with routine physiotherapy) and c (routine physiotherapy alone) means the control groups. First, a number is assigned to each of the blocks (aabbcc cabbac abcabc bacbac cbaabc bbaacc ccaabb aaccbb ccbbaa) randomly from 1 to 9, then people are placed in the blocks from block one and from the left. and based on the letter (a, b, and c) that is chosen for each person, the person enters the intervention or control groups. The participants, the therapist and the evaluator will be unaware of the grouping. To implement the generated random sequence, the method of hiding the box or coded cans is used. In this method, the cans will be numbered based on a random sequence, and inside the boxes, the intended intervention will be provided to the therapist with a sheet on which random allocation is written, with the condition that the boxes are sealed and completely confidential. and the therapist will assign them to the intervention and control groups based on the order of arrival of the patients, Blinding description: A physiotherapist will be in charge of the treatment process and another physiotherapist will evaluate the desired variables. For this reason, the study will be a single-blind study from the evaluator. N/A Primary shoulder impingement syndrome. Intervention 1: Intervention group: Treatment in the intervention group (15 people) includes 24 sessions (8 weeks, 3 days a week, every other day). At the beginning of the treatment sessions, 20 minutes of hot pack, 20 minutes of conventional transcutaneous electrical nerve stimulation (TENS) and 5 minutes of 1 MHz and 1.5 intensity ultrasound are performed. Then, before doing the exercises, the people of this group perform upper limb cycling exercises without resistance for 5 minutes, then, based on the standard shoulder exercise protocol, progressive resistance exercises of the external rotator muscles of the arm (infraspinatus and teres minor) including external rotation exercises of the arm in the neutral position, 45 degrees of abduction, 90 degrees of abduction and in the weight bearing position and progressive resistance exercises of the stabilizer muscles of the movement of the external rotation of the arm (middle and lower trapezius) including scapular retraction and T and Y exercises with EMG biofeedback and under external resistance by Theraband. The amount of resistance applied by Theraband (Theraband color) is increased and determined as a percentage of the maximal voluntary isometric contraction (MVIC) of each muscle according to the desired week from 50% to 80% of MVIC. This resistance is determined weekly. Also, the exercises are done in 10 repetition in each set, and the number of sets increases from 2 sets to 3 sets according to the desired week. Also, oscillation is added to the end of the exercises to apply more resistance along with the progress of the exercises. At the end, a cold pack is used for 10 minutes to prevention of pain and inflammation after the exercises. Range of motion exercises are repeated ten times a day and stretching exercises are performed five times a day. Intervention 2: Control group: The treatment in the first control group (15 people) includes 24 sessions (8 weeks, 3 days a week, every other day). The treatment in this group will be the same as the intervention group, with the difference that this group will perform exercises without EMG biofeedback. exercise resistance is also determined by Theraband and based on the percentage of MVIC at the beginning of each week (Theraband color), then the people of this group perform the exercises with the determined Theraband and without EMG biofeedback. Intervention 3: Control group: The treatment in the second control group (15 people) includes 24 sessions (8 weeks, 3 days a week, every other day). In this group, only routine physiotherapy including 20 minutes of hot pack, 20 minutes of conventional transcutaneous electrical nerve stimulation (TENS) and 5 minutes of 1 MHz and 1.5 intensity ultrasound is performed, and this group does not perform therapeutic exercise intervention. At the end of the study, the results will be evaluated and compared with other groups. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Mehran Borjipour
Neuromuscular Rehabilitation Research Center, Quds Blvd.
Semnan Iran (Islamic Republic of) 3519698375 +98 23 3332 8502 borjimehran78@gmail.com Semnan University of Medical Sciences scientific Dr. Cyrus Taghizadeh Delkhoush
Neuromuscular Rehabilitation Research Center, Quds Blvd.
Semnan Iran (Islamic Republic of) 3519698375 +98 23 3332 8502 cyrustaghizadeh@yahoo.com Semnan University of Medical Sciences Iran (Islamic Republic of) Onset of shoulder pain less than a year ago Pain in the anterior or lateral part of the upper arm Shoulder pain in the range of VAS less than 4 (1 to 3) Positiveness of at least 3 of the following: painful arch during flexion or abduction movements - positive Neer test - positive Kennedy-Hawkins test - positive Jobe test - pain during resisted movement of external rotation or abduction The involved side is the dominant side of the person Persistent pain for at least one week in the past six months Without limitation in shoulder range of motion Age between 18 and 35 years Normal BMI (18.5 to 24.9) 18 years 35 years Both Pain in both shoulders at the same time Positive drop arm test for complete rotator cuff tear Instability or hypermobility of the glenohumeral joint (sulcus sign) History of heart disease pregnancy Person cannot work with electromyographic biofeedback Other orthopedic diseases in the upper quadrant of the skeleton Systemic diseases Neurological diseases Surgery, fracture, dislocation or subluxation in the upper quadrant of the skeleton People who have taken corticosteroid drugs in the last six months People who have taken any medicine in the previous two weeks People who have received cervical or shoulder girdle rehabilitation in the last six months M75.4 Impingement syndrome of shoulder Treatment - Devices N/A N/A Intervention group: Treatment in the intervention group (15 people) includes 24 sessions (8 weeks, 3 days a week, every other day). At the beginning of the treatment sessions, 20 minutes of hot pack, 20 minutes of conventional transcutaneous electrical nerve stimulation (TENS) and 5 minutes of 1 MHz and 1.5 intensity ultrasound are performed. Then, before doing the exercises, the people of this group perform upper limb cycling exercises without resistance for 5 minutes, then, based on the standard shoulder exercise protocol, progressive resistance exercises of the external rotator muscles of the arm (infraspinatus and teres minor) including external rotation exercises of the arm in the neutral position, 45 degrees of abduction, 90 degrees of abduction and in the weight bearing position and progressive resistance exercises of the stabilizer muscles of the movement of the external rotation of the arm (middle and lower trapezius) including scapular retraction and T and Y exercises with EMG biofeedback and under external resistance by Theraband. The amount of resistance applied by Theraband (Theraband color) is increased and determined as a percentage of the maximal voluntary isometric contraction (MVIC) of each muscle according to the desired week from 50% to 80% of MVIC. This resistance is determined weekly. Also, the exercises are done in 10 repetition in each set, and the number of sets increases from 2 sets to 3 sets according to the desired week. Also, oscillation is added to the end of the exercises to apply more resistance along with the progress of the exercises. At the end, a cold pack is used for 10 minutes to prevention of pain and inflammation after the exercises. Range of motion exercises are repeated ten times a day and stretching exercises are performed five times a day. Control group: The treatment in the first control group (15 people) includes 24 sessions (8 weeks, 3 days a week, every other day). The treatment in this group will be the same as the intervention group, with the difference that this group will perform exercises without EMG biofeedback. exercise resistance is also determined by Theraband and based on the percentage of MVIC at the beginning of each week (Theraband color), then the people of this group perform the exercises with the determined Theraband and without EMG biofeedback. Control group: The treatment in the second control group (15 people) includes 24 sessions (8 weeks, 3 days a week, every other day). In this group, only routine physiotherapy including 20 minutes of hot pack, 20 minutes of conventional transcutaneous electrical nerve stimulation (TENS) and 5 minutes of 1 MHz and 1.5 intensity ultrasound is performed, and this group does not perform therapeutic exercise intervention. At the end of the study, the results will be evaluated and compared with other groups. Normalized muscle electrical activity. Timepoint: Before and After of the Intervention. Method of measurement: Surface EMG. Pain. Timepoint: Before and After of the Intervention. Method of measurement: Visual analogue scale (VAS). Functional disability. Timepoint: Before and After of the Intervention. Method of measurement: The disabilities of the arm, shoulder and hand (DASH) questionnaire. Semnan University of Medical Sciences Approved 2024-03-11 Research Ethics Committees of Semnan University Of Medical Sciences and Health Services Basij Blvd, Semnan University of Medical Sciences Semnan Semnan Iran (Islamic Republic of)