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IRCT20191208045652N6 IRCT 2022-12-07 Iran University of Medical Sciences The effectiveness of a type of manual therapy on clinical sign in individuals with low back pain The effectiveness of muscle energy techniques on some clinical signs in participants with myofascial trigger points related to chronic non-specific back pain: Study protocol for a double-blind randomized controlled trial 2023-01-20 anticipated 33 Complete https://irct.ir/trial/66306 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: All eligible chronic non-specific low back pain patients will be randomized to an intervention group ( muscle energy techniques and routine physical therapy) and a control group (sham muscle energy techniques and routine physical therapy) with a ratio of 1:1. Randomized allocation will be performed by using permuted block randomization method, which consists of four-letter blocks made of letters A and B. Then, the random treatment list that will be obtained at the end of the random allocation task will be placed in letters A and B inside the sealed and numbered envelopes (muscle energy techniques and letter B indicates sham muscle energy techniques). The random assignment process will be performed by someone outside the research team before the study begins. After the initial evaluation of the patient by the examiner, the numbered envelopes will be presented to him/her 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. Patients are asked not to provide their grouping information to the assessor to prevent data contamination, Blinding description: In this study, participants, outcome assessor and data analyzer will be kept blind to being assigned to the study groups. Blinding method: A) Participants: Participants will not have information about which treatment group they have entered, and also in each treatment group, people will receive a real treatment in addition to sham of the real treatment in the other group (the first group includes muscle energy techniques and the second group includes sham muscle energy techniques ) were used so the participants could not guess which treatment group they have entered. B) Outcome assessor: Outcome assessment will be performed by a person who does not know the grouping of the individuals and the treatments performed in each treatment group. C) Data analyzer: Data analysis will be performed by a person who does not know the grouping of individuals and the treatments performed in each treatment group. N/A chronic nonspecific low back pain. Intervention 1: Intervention group:The treatments of this group include muscle energy techniques and routine physiotherapy: a) Muscle energy techniques: This technique is performed for the quadratus lumborum, erector spinae and gluteus medius muscles. To perform this technique after being in the treatment position The patient is asked to contract the muscle with a low power and a maximum of 20-35% of his power. After 5 to 7 seconds, the patient is asked to relax completely, then the therapist takes the muscle to a stretched position and maintains the stretched position for 30 seconds. After 2 to 3 seconds of rest, the above steps will be repeated 3 times.b)Routine physiotherapy includes a low-power diode laser (LAS-Expert, physiomed, made in Germany - with 14 diodes), wavelength 785 nm, output power 700 mW, with a frequency of 50 to 60 Hz, 50 J/cm2, as a pulse frequency With 80% duty cycle = 1.5 to 2 cm outside the spines of the lumbar vertebrae, it will be used for approximately 20 minutes.Core stability exercises will consist of three stages of exercises, The first week will include the exercises of the first stage, the second weeks include the first and second stage exercises, and the third week will include all of the exercises. The first stage exercises will include: abdominal drawing, abdominal bracing lift and alternative arm and leg lift, the second stage exercises will include: unilateral bridging, sideway bridging, quadruped contralateral arm and leg lift, curl up, diagonal curl up, sit back and the third stage exercises will include: bridging on swiss ball, diagonal curl up with elastic band, trunk extension on swiss ball, unilateral bridging with weight cuff and forward step up. Each exercise will be repeated 10 times and each repetition will last 10 seconds and there will be one minute break between each exercise. This group will be treated for 9 sessions over 3 weeks. Intervention 2: Control group:The treatments of this group include sham muscle energy techniques and routine physiotherapy: a) Sham muscle energy techniques are performed for the quadratus lumborum, erector spinae and gluteus medius muscles. In this way, the muscle is brought to the position of performing the technique, but no technique is performed.The treatment time will be the same in both groups. b)Routine physiotherapy includes a low-power diode laser (LAS-Expert, physiomed, made in Germany - with 14 diodes), wavelength 785 nm, output power 700 mW, with a frequency of 50 to 60 Hz, 50 J/cm2, as a pulse frequency With 80% duty cycle = 1.5 to 2 cm outside the spines of the lumbar vertebrae, it will be used for approximately 20 minutes.Core stability exercises will consist of three stages of exercises, The first week will include the exercises of the first stage, the second weeks include the first and second stage exercises, and the third week will include all of the exercises. The first stage exercises will include: abdominal drawing, abdominal bracing lift and alternative arm and leg lift, the second stage exercises will include: unilateral bridging, sideway bridging, quadruped contralateral arm and leg lift, curl up, diagonal curl up, sit back and the third stage exercises will include: bridging on swiss ball, diagonal curl up with elastic band, trunk extension on swiss ball, unilateral bridging with weight cuff and forward step up. Each exercise will be repeated 10 times and each repetition will last 10 seconds and there will be one minute break between each exercise. This group will be treated for 9 sessions over 3 weeks. 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 There is no further information
public Shirin azizi
Golestan Dormitory, Madadkaran street, Shahid Shahnazari street, Madar square, Mirdamad boulevard
Tehran Iran (Islamic Republic of) 1545913487 +98 21 2225 6434 shirin.azizi.al@gmail.com Iran University of Medical Sciences scientific Marzieh Yassin
Physical therapy department, Rasoul Akram hospital, Niayesh street, Sattarkhan street
Tehran Iran (Islamic Republic of) 1445613131 +98 21 2222 8052 m.yassin.pt@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Patients aged between 20 to 50 years No referral pain to lower extremities Moderate pain intensity (between 3 to 6) based on Numerical Pain Rating Scale Patients with trigger points in the quadratus lumborum and erector spine muscles and gluteus medius muscle 20 years 50 years Both History of lumbar surgery Complications that affect the treatment process such as systemic diseases, neurological disorders, inflammatory conditions, infectious conditions, structural and degenerative changes, metabolic bone diseases and bleeding disorder. Fracture People who have received exercise therapy or manual treatments or dry needling for the lumbar region in past month. Active cancer Pregnancy Long history of steroid use M54.5 low back pain Rehabilitation Placebo Intervention group:The treatments of this group include muscle energy techniques and routine physiotherapy: a) Muscle energy techniques: This technique is performed for the quadratus lumborum, erector spinae and gluteus medius muscles. To perform this technique after being in the treatment position The patient is asked to contract the muscle with a low power and a maximum of 20-35% of his power. After 5 to 7 seconds, the patient is asked to relax completely, then the therapist takes the muscle to a stretched position and maintains the stretched position for 30 seconds. After 2 to 3 seconds of rest, the above steps will be repeated 3 times.b)Routine physiotherapy includes a low-power diode laser (LAS-Expert, physiomed, made in Germany - with 14 diodes), wavelength 785 nm, output power 700 mW, with a frequency of 50 to 60 Hz, 50 J/cm2, as a pulse frequency With 80% duty cycle = 1.5 to 2 cm outside the spines of the lumbar vertebrae, it will be used for approximately 20 minutes.Core stability exercises will consist of three stages of exercises, The first week will include the exercises of the first stage, the second weeks include the first and second stage exercises, and the third week will include all of the exercises. The first stage exercises will include: abdominal drawing, abdominal bracing lift and alternative arm and leg lift, the second stage exercises will include: unilateral bridging, sideway bridging, quadruped contralateral arm and leg lift, curl up, diagonal curl up, sit back and the third stage exercises will include: bridging on swiss ball, diagonal curl up with elastic band, trunk extension on swiss ball, unilateral bridging with weight cuff and forward step up. Each exercise will be repeated 10 times and each repetition will last 10 seconds and there will be one minute break between each exercise. This group will be treated for 9 sessions over 3 weeks Control group:The treatments of this group include sham muscle energy techniques and routine physiotherapy: a) Sham muscle energy techniques are performed for the quadratus lumborum, erector spinae and gluteus medius muscles. In this way, the muscle is brought to the position of performing the technique, but no technique is performed.The treatment time will be the same in both groups. b)Routine physiotherapy includes a low-power diode laser (LAS-Expert, physiomed, made in Germany - with 14 diodes), wavelength 785 nm, output power 700 mW, with a frequency of 50 to 60 Hz, 50 J/cm2, as a pulse frequency With 80% duty cycle = 1.5 to 2 cm outside the spines of the lumbar vertebrae, it will be used for approximately 20 minutes.Core stability exercises will consist of three stages of exercises, The first week will include the exercises of the first stage, the second weeks include the first and second stage exercises, and the third week will include all of the exercises. The first stage exercises will include: abdominal drawing, abdominal bracing lift and alternative arm and leg lift, the second stage exercises will include: unilateral bridging, sideway bridging, quadruped contralateral arm and leg lift, curl up, diagonal curl up, sit back and the third stage exercises will include: bridging on swiss ball, diagonal curl up with elastic band, trunk extension on swiss ball, unilateral bridging with weight cuff and forward step up. Each exercise will be repeated 10 times and each repetition will last 10 seconds and there will be one minute break between each exercise. This group will be treated for 9 sessions over 3 weeks. Pain intensity based on Numerical Pain Rating Scale. Timepoint: Pain intensity measurement before intervention and after intervention. Method of measurement: numerical pain rating scale. Range of motion. Timepoint: Before intervention and after intervention. Method of measurement: goniameter. Pain pressure threshold. Timepoint: before and after intervention. Method of measurement: algometer. Functional disability. Timepoint: before and after intervention. Method of measurement: oswestry disability index questionnaire. Iran University of Medical Sciences Approved 2022-05-31 Ethics committee of Iran University of Medical Sciences Dormitory of the school of Rehabilitation of Iran University of Medical Sciences, Shah nazari Ave., Madar square, Mirdamad Blvd Tehran Tehran Iran (Islamic Republic of)