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IRCT20190617043918N1 IRCT 2019-07-03 Tehran University of Medical Sciences Study of the clinical, biomechanical, and functional effects of dry needling on spastic gastronemius muscle in patients with multiple sclerosis Dry needling به اختصار می شود DN ، Multiple sclerosis به اختصار می شود MS Comparison of the effects of dry needling on spastic gastronemius muscle in patients with multiple sclerosis 2019-07-22 anticipated 24 Complete https://irct.ir/trial/40413 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Simple randomization Patients are randomly divided into treatment and control groups. In order to randomly distribute patients, packets that are packed in equal quantities for both groups will be prepared and contain the terms "treatment" and "control" that will be selected by the secretary and will be entered into the treatment or control group accordingly, Blinding description: This is a double-blind clinical study, in which an experienced physiotherapist will be doing intervention and another physiotherapist will be evaluating. As a result, the evaluator does not know which group the patient belongs to. On the other hand, patients are unaware of whether they are in the intervention group or on the waiting list. N/A Multiple sclerosis. Intervention 1: Intervention group: in the interventional group, DN , when the patient are in prone position, the con shaped dry needling will be done for one minute for medial and latral heads of the gastrocnemius muscle.In the prone position, a pillow is placed under the spastic foot of the patient, a line will be drawn from the middle of the linear heel to the populiteal fossa’s middle point, dividing the line into three parts, and then move 2 cm in the middle of the proximal segment towards the lateral side of shin, and needle is penetrated. The procedure for dry needing of the medial head of the gastrocnemius muscle is like that of latral head, except that it will be penetrated moving of 1/3 of distal part of proximal segment towards shin. Intervention 2: Control group: In control group, after first evaluations, the patients will be wait to be reassessed (without any intervention). Yes - There is a plan to make this available What will be shared: The whole data can be shared after unidentifiable people. When: Six months after the publication of each group results , release the data is possible. To whom: Data access is free to the public. Conditions: The use of data in order to achive the study mechanism is free. Where to obtain: To receive the data, please contact Mr. Omid Motamedzadeh Sabeti with the following emails and address. motamedzadeh-o@ razi.tums.ac.ir motamed.omid@yahoo.com School of Rehabilitation,Tehran University of Medical Sciences, Enghelab Ave., Piche-e-shemiran How to obtain: The applicant submits an application to Mr. Omid Motamedzadeh by sending an email and after receiving the identity information, the data will be sent to him. Comments:
public Omid Motamedzadeh Sabeti
School of Rehabilitation,Tehran University of Medical Sciences, Enghelab Ave., Piche-e-shemiran
Tehran Iran (Islamic Republic of) 11489-65111 +98 21 2286 7320 motamedzadeh-o@razi.tums.ac.ir Tehran University of Medical Sciences scientific Omid Motamedzadeh Sabeti
School of Rehabilitation,Tehran University of Medical Sciences, Enghelab Ave., Piche-e-shemiran
Tehran Iran (Islamic Republic of) 11489-65111 +98 21 2286 7320 motamedzadeh-o@razi.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Definitive diagnosis of MS (relapsing-remitting type) Lake of other neurological diseases Ability to walk with or without auxiliary equipment Ability to understand commands EDSS with a score of 3 to 7 Severity of spasticity of plantar flexors is equal to or greater than 1(using MMAS) Lack of passive ankle limitation is more than 10% Lake of Botox injection since three months ago Absence of any kind of confrontation for DN No acute attack in the last month no limit no limit Both Unwillingness to continue cooperation of patient for any reason Occurrence of a new attack during the course of participating research Use of anti-spasticity drugs during the research period G35 Multiple sclerosis Rehabilitation Rehabilitation Intervention group: in the interventional group, DN , when the patient are in prone position, the con shaped dry needling will be done for one minute for medial and latral heads of the gastrocnemius muscle.In the prone position, a pillow is placed under the spastic foot of the patient, a line will be drawn from the middle of the linear heel to the populiteal fossa’s middle point, dividing the line into three parts, and then move 2 cm in the middle of the proximal segment towards the lateral side of shin, and needle is penetrated. The procedure for dry needing of the medial head of the gastrocnemius muscle is like that of latral head, except that it will be penetrated moving of 1/3 of distal part of proximal segment towards shin. Control group: In control group, after first evaluations, the patients will be wait to be reassessed (without any intervention). Spasticity of plantar flexors muscles measured its intensity based on the MMAS scale from zero to four. Timepoint: measurements will be done before intervention, immediately after it and one week later. Method of measurement: spasticity is the resistance level that the therapist felt during dorsiflexion of the patient's ankle and measured its intensity based on the MMAS scale from zero to four. Passive torque of plantar flexor muscles , The maximum force obtained in terms of Newton’s is multiplied to distance (m) between the head of the third metatarsal to the ankle joint axis and the maximum torque is obtained in terms of Nm. Timepoint: measurements will be done before intervention, immediately after it and one week later. Method of measurement: An ankle stiffness is evaluated using a manual micro-muscle tester. The center of the sensitive dynamometer pad is locating in the center of the metatarsal arch in the third metatarsal head, and the passive resistance force of the plantar flexors against the ankle dorsiflexion is recorded by dynamometer in the knee extension position. In this way, like the clinical method of measuring spasticity by counting 1001, the ankle joint will be quickly turned from its rest position to the maximum dorsiflexion.The maximum force obtained in terms of Newton’s is multiplied to distance (m) between the head of the third metatarsal to the ankle joint axis and the maximum torque is obtained in terms of Nm. Maximum foot pressure, for study of foot pressure in static, the maximum pressure and foot force variables are examined by the foot scan. Timepoint: measurements will be done before intervention, immediately after it and one week later. Method of measurement: we want the patient to stand straight and look at the point on the facing wall and count from 100 in reverse, then the at time interval when the patient is counting and concentrating, operator scans the participant's foot. In this research, dynamic mobilities test is determined by measuring the time taken to run the Time up and go (TUG) test by stopwatch. Timepoint: measurements will be done before intervention, immediately after it and one week later. Method of measurement: the examiner asks the patient to sit comfortably on an armchair with his legs touching the ground, and by the therapist order, "go" rose up from the chair, and passing a 3-meter distance on the ground, then round and return to the same seat and sits down. Eventually, time is recorded using a timer. Dorsiflexion range of motion. Timepoint: measurements will be done before intervention, immediately after it and one week later. Method of measurement: To do this, an ankle goniometr is used. To measure active range of motion, we ask the patient to perform ankle dorsiflexion in a straight-knee position. To measure the passive range, keep the tibia and the fibula with one hand and hold the heel together with the flat plate of the goniometer with another hand and pull it slowly down to achieve the maximum dorsiflexion. Tehran University of Medical Sciences Approved 2019-05-19 Ethics Committee on Research in Nursing and Midwifery Faculty and Faculty of Rehabilitation, Tehran School of Rehabilitation,Tehran University of Medical Sciences, Enghelab Ave., Piche-e-shemiran tehran Tehran Iran (Islamic Republic of)