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IRCT20211005052677N1 IRCT 2022-02-19 Iran University of Medical Sciences Effect of dry needling in the treatment of patients with rotator cuff repair surgery The effectiveness of dry needling with routine physiotherapy compared to routine physiotherapy on pain and range of motion in patients with rotator cuff repair surgery 2022-02-20 anticipated 52 Complete https://irct.ir/trial/59505 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: All eligible rotator cuff repair participants will be randomly assigned into routine physiotherapy plus dry needling (group 1) and routine physiotherapy plus sham dry needling (group 2) with an allocation ratio of 1:1. Randomization will be performed using variable blocks with 4 character blocks containing letters A, B. After randomizing, the randomization schedule will be transferred into written instructions and will be placed in sequentially numbered, opaque, and sealed envelopes (Letter A indicates dry needle plus routine physiotherapy and letter B indicates sham dry needle plus routine physiotherapy).The randomization process will be performed by someone who is outside the research team before the study begins. After the initial evaluation of the patients by the examiner, the numbered envelopes will be given to each patient according to the ordinal number of each person admitted to the study. Finally, after each patient enters the treatment sessions, the therapist will adjust the treatment interventions based on the letters in the envelope. It should also be noted that after placing patients in the target group, they are asked not to provide their grouping information to the examiner to prevent data contamination, Blinding description: Patients blinding: Before starting the study, patients are given enough information about their treatment and grouping. But after starting the study and grouping, patients do not know that they are in which of the main treatment group or control group. Outcome assessor blinding: The examiner who evaluates the outcomes before and after the intervention does not know the grouping of patients and does not know in which of the main treatment or control groups the patients being evaluated are. N/A Rotator cuff repair surgery. Intervention 1: Intervention group: Patients in the intervention group after diagnosis of trigger points in the shoulder girdle muscles will receive Dry needling technique of the shoulder girdle muscles (upper and middle and lower trapezius, Levator scapula, Rhomboid minor, Rhomboid major, Supraspinatus, Infraspinatus, Subscapularis, Teres Major, Teres Minor Deltoid) and conventional physiotherapy treatments that include electrical stimulation (Conventional TENS with a frequency of 120-180 Hz), manual therapies (mobilization of the Glenohumeral and Scapulothoracic joints), exercise therapy (exercises to increase the range of motion of the shoulder joints, strengthening exercises of the shoulder muscles).The number of treatment sessions for these patients is 10 in total, who receive 3 sessions of treatment per week every other day. . Patients receive conventional physiotherapy treatment in each session, but the dry needling technique will be performed in sessions 3, 5, 7, 9. In this study, myofascial trigger points will be identified by flat palpation of the taut bands between muscle fibers that produce referral pain or local twitch response. The method of performing the muscle needle technique will be based on the approaches proposed by Dommerholt and Fernandez de-las-Penas. After obtaining written consent from patients and preparing trigger points using alcohol-soaked cotton, a dry needle (acupuncture needle) is inserted directly into the muscles involved in the shoulder girdle in order to obtain local twitch response, and this will continue until no twitch response is obtained from the muscle. Finally, according to Hong's recommendation, the dry needle will remain in place for 20 minutes. An exercise training sheet will be given to the patients that explains home exercises. participants should perform home exercises 2 or 3 times a day for 4 weeks. Intervention 2: Control group: In the control group, patients will receive routine physiotherapy treatment as in the main treatment group, which includes electrical stimulation (Conventional TENS with a frequency of 120-180), manual therapies (mobilization of the Glenohumeral and Scapulotorasic joints), exercise therapy (exercises to increase the range of motion of the shoulder joints, Shoulder muscle strength training). But instead of dry needling technique, they receive sham dry needle. In order to blind patients, the sham dry needling method is similar to the main method in all the steps, including how the patient is placed or how the technique is performed. The location of the trigger point in the patient is determined, then the patient is placed in the position that is the best way to perform dry needling of the target muscle, and after cleaning the area with alcohol-soaked cotton, the needle will insert subcutaneously, and then it remains in place for 20 minutes similar to the main dry needle method. In addition, the number of treatment sessions is similar to the main intervention group that is generally 10 sessions, which in sessions 3, 5, 7, 9 sham dry needling will be performed. Yes - There is a plan to make this available What will be shared: Only main outcome measures will be shared. When: 6 months after final reports To whom: Only academic researchers Conditions: Only academic researchers Where to obtain: To main investigator via email address How to obtain: After receiving the request from the claimant and checking his eligibility, the response will be done via email after approximately one month. Comments:
public Faeze Naseri
ladan Dead end, East Akhtar, 45 Golshhr
Karaj Iran (Islamic Republic of) 313871649 +98 26 3460 7430 faezenaseri94@yahoo.com Iran University of Medical Sciences scientific Mehdi Dadgoo
Iran University of Medical Sciences School of Rehabilitation, Madadkaran Avenue, Shah nazari Avenue, Madar Square, Mirdamad
Tehran Iran (Islamic Republic of) 158754391 +98 21 2222 8051 Dadgoo.m@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Age range between 40 to 75 years Patients who have undergone rotator cuff repair surgery Patients who have passed at least 5 weeks since their surgery and they report shoulder pain Patients who have trigger points in shoulder girdle muscles palpation 40 years 75 years Both Phobia of needle History of coagulation disorders and intake of anticoagulants History of head and neck surgery Radiculopathy and myelopathy disorders Pregnancy M75.1 Rotator cuff tear or rupture, not specified as traumatic Rehabilitation Rehabilitation Intervention group: Patients in the intervention group after diagnosis of trigger points in the shoulder girdle muscles will receive Dry needling technique of the shoulder girdle muscles (upper and middle and lower trapezius, Levator scapula, Rhomboid minor, Rhomboid major, Supraspinatus, Infraspinatus, Subscapularis, Teres Major, Teres Minor Deltoid) and conventional physiotherapy treatments that include electrical stimulation (Conventional TENS with a frequency of 120-180 Hz), manual therapies (mobilization of the Glenohumeral and Scapulothoracic joints), exercise therapy (exercises to increase the range of motion of the shoulder joints, strengthening exercises of the shoulder muscles).The number of treatment sessions for these patients is 10 in total, who receive 3 sessions of treatment per week every other day. . Patients receive conventional physiotherapy treatment in each session, but the dry needling technique will be performed in sessions 3, 5, 7, 9. In this study, myofascial trigger points will be identified by flat palpation of the taut bands between muscle fibers that produce referral pain or local twitch response. The method of performing the muscle needle technique will be based on the approaches proposed by Dommerholt and Fernandez de-las-Penas. After obtaining written consent from patients and preparing trigger points using alcohol-soaked cotton, a dry needle (acupuncture needle) is inserted directly into the muscles involved in the shoulder girdle in order to obtain local twitch response, and this will continue until no twitch response is obtained from the muscle. Finally, according to Hong's recommendation, the dry needle will remain in place for 20 minutes. An exercise training sheet will be given to the patients that explains home exercises. participants should perform home exercises 2 or 3 times a day for 4 weeks. Control group: In the control group, patients will receive routine physiotherapy treatment as in the main treatment group, which includes electrical stimulation (Conventional TENS with a frequency of 120-180), manual therapies (mobilization of the Glenohumeral and Scapulotorasic joints), exercise therapy (exercises to increase the range of motion of the shoulder joints, Shoulder muscle strength training). But instead of dry needling technique, they receive sham dry needle. In order to blind patients, the sham dry needling method is similar to the main method in all the steps, including how the patient is placed or how the technique is performed. The location of the trigger point in the patient is determined, then the patient is placed in the position that is the best way to perform dry needling of the target muscle, and after cleaning the area with alcohol-soaked cotton, the needle will insert subcutaneously, and then it remains in place for 20 minutes similar to the main dry needle method. In addition, the number of treatment sessions is similar to the main intervention group that is generally 10 sessions, which in sessions 3, 5, 7, 9 sham dry needling will be performed. Resting pain. Timepoint: First session (before starting the intervention) and 10th session (after completing the intervention). Method of measurement: Using the 0-100 Numeric Pain Rating Scale. Active range of motion. Timepoint: First session (before starting the intervention) and 10th session (after completing the intervention). Method of measurement: Using Goniometer. Passive range of motion. Timepoint: First session (before starting the intervention) and 10th session (after completing the intervention). Method of measurement: Using Goniometer. Strength of shoulder girdle muscles. Timepoint: First session (before starting the intervention) and 10th session (after finishing the intervention). Method of measurement: Using a manual dynamometer. Functional status. Timepoint: First session (before starting the intervention) and 10th session (after finishing the intervention). Method of measurement: Using the Shoulder Pain And Disability Index. Iran University of Medical Sciences Approved 2021-10-16 Ethics Committee of Iran University of Medical sciences No. 16, ladan Dead end, East Akhtar, 45 Golshahr, Karaj3 Karaj Alborz Iran (Islamic Republic of)