Protocol summary
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Study aim
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Determining the Clinical, Biomechanical and Functional Effects of Dry Needle on Spastic Gastrocnemius Muscle in Patients with Multiple Sclerosis
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Design
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Controlled clinical trial, parallel group trial, double blinded examiner and participant, randomised
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Settings and conduct
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The study is conducted at the Physical Therapy Clinic of Sina hospital. Participants will pass two test categories (standing and sitting). After the end of the evaluation, the patients in the waiting list are waiting to be reassessed and in the DN treatment group, when the patient are in prone position, DN will be done for gastrocnemius muscle. All evaluations will be repeated for the following two weeks as follow-ups.
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Participants/Inclusion and exclusion criteria
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People with MS who have spasticity in the lower limbs.
arrival conditions:
Definitive diagnosis of MS (relapsing-remitting type)
Lake of other neurological diseases
Ability to walk with or without auxiliary equipment
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%
No acute attack in the last month
Non-arrival conditions:
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
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Intervention groups
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After the end of frist evaluation, the patients in the waiting list are waiting to be reassessed and in the DN treatment group, when the patient are in prone position, the con shaped dry needling (0/22*30) will be done for one minute for each muscle on the medial and latral heads of the gastrocnemius muscle.
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Main outcome variables
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MMAS measurements, active and passive motion range, and the passive torque of the ankle plantar flexor, pressure in different points of foot and dynamic mobility test for lower limb.
General information
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Reason for update
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Due to the prevalence of coronavirus, more time is needed to gather information.
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Acronym
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Dry needling به اختصار می شود DN ، Multiple sclerosis به اختصار می شود MS
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IRCT registration information
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IRCT registration number:
IRCT20190617043918N1
Registration date:
2019-07-03, 1398/04/12
Registration timing:
prospective
Last update:
2020-11-09, 1399/08/19
Update count:
1
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Registration date
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2019-07-03, 1398/04/12
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-07-22, 1398/04/31
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Expected recruitment end date
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2021-12-21, 1400/09/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison of the effects of dry needling on spastic gastronemius muscle in patients with multiple sclerosis
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Public title
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Study of the clinical, biomechanical, and functional effects of dry needling on spastic gastronemius muscle in patients with multiple sclerosis
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
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
Exclusion criteria:
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
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Age
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No age limit
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Outcome assessor
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Sample size
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Target sample size:
24
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-05-19, 1398/02/29
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Ethics committee reference number
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IR.TUMS.FNM.REC.1398.022
Health conditions studied
1
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Description of health condition studied
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Multiple sclerosis
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ICD-10 code
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G35
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ICD-10 code description
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Multiple sclerosis
Primary outcomes
1
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Description
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spasticity of plantar flexors muscles measured its intensity based on the MMAS scale from zero to four.
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Timepoint
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measurements will be done before intervention, immediately after it and one week later.
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Method of measurement
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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.
2
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Description
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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.
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Timepoint
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measurements will be done before intervention, immediately after it and one week later.
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Method of measurement
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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.
3
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Description
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Maximum foot pressure, for study of foot pressure in static, the maximum pressure and foot force variables are examined by the foot scan.
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Timepoint
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measurements will be done before intervention, immediately after it and one week later.
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Method of measurement
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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.
4
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Description
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In this research, dynamic mobilities test is determined by measuring the time taken to run the Time up and go (TUG) test by stopwatch.
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Timepoint
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measurements will be done before intervention, immediately after it and one week later.
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Method of measurement
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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.
Secondary outcomes
1
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Description
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dorsiflexion range of motion
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Timepoint
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measurements will be done before intervention, immediately after it and one week later
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Method of measurement
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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.
Intervention groups
1
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Description
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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.
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Category
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Rehabilitation
2
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Description
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Control group: In control group, after first evaluations, the patients will be wait to be reassessed (without any intervention).
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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70
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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The whole data can be shared after unidentifiable people.
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When the data will become available and for how long
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Six months after the publication of each group results , release the data is possible.
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To whom data/document is available
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Data access is free to the public.
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Under which criteria data/document could be used
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The use of data in order to achive the study mechanism is free.
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From where data/document is obtainable
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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
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What processes are involved for a request to access data/document
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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.
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Comments
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