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IRCT20230708058719N1 IRCT 2023-08-02 Tehran University of Medical Sciences Effect of Dry needling on decreasing elbow flexor stiffness in stroke patients The effect of dry needling on elbow flexor spasticity and corticospinal excitability in patients with chronic stroke: A double-blind, randomized, controlled trial 2023-09-01 anticipated 30 Complete https://irct.ir/trial/71165 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block-Balanced Randomization:In this study, block balanced randomization is used to ensure that participants are allocated equally to each group. In order to maintain balance throughout the experiment, each block has an equal amount of each intervention, randomly assigned in unpredictable orders, Blinding description: This study used a double-blind randomized controlled trial design, wherein one proficient physiotherapist administers the treatments, while another physiotherapist conducts the assessments. Consequently, the evaluator lacks knowledge regarding the patient's group status, and the patients themselves remain unaware of their respective group assignments. N/A chronic stroke. Intervention 1: Intervention group: In order to execute the intervention, the patient assumes a supine position. The head is positioned upon the pillow, aligned with the midline. The arms are slightly abducted, with the elbows slightly flexed and the forearms in a supinated position. The anterior aspect of the arm is sterilized using alcohol. Subsequently, within the dry needling group a sterile needle measuring 0.3 x 0.5 is employed by the Fast-in and Fast-out conical technique to administer needling to the biceps brachialis and brachialis muscles for a duration of one minute. The biceps brachii and brachialis muscles are penetrated at a distance of 2 centimeters out of the point where the upper three-fourths and lower one-fourth of the line connecting the coracoid process to the medial epicondyle of the humerus intersect. Intervention 2: Control group: instead of dry needles, sham needles will be employed to target the same muscle groups as previously mentioned. Sham needles have a relatively wide edge that solely induces skin irritation without penetrating the dermal layer. Yes - There is a plan to make this available What will be shared: The raw data and analysis of the research will be made available to researchers upon their request, should it be deemed necessary by the researchers When: Following the publication of the articles derived from the conducted research To whom: Scholars conducting research within academic establishments Conditions: The data is exclusively accessible to fellow researchers for the purpose of studying and evaluating treatment outcomes Where to obtain: by contacting the corresponding author through email How to obtain: Send an email to the responsible author and request the document Comments:
public Noureddin Nakhostin Ansari
Tehran, District 12, Enghelab St، Pich-e-Shemiran
Tehran Iran (Islamic Republic of) 1148956111 +98 21 7753 3939 nakhostin@sina.tums.ac.ir Tehran University of Medical Sciences scientific Shiva Komesh
Tehran, District 12, Enghelab St، Pich-e-Shemiran
Tehran Iran (Islamic Republic of) 1148956111 +98 21 7753 3939 sh-komesh@razi.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) stroke-induced hemiplegia A minimum of six months have passed since the occurrence of the stroke, indicating a chronic stage of the disease. The degree of spasticity exhibited by the elbow flexor muscles on the affected side, as determined by the Modified Modified Ashworth Scale (MMAS), is a minimum of 1. Age 30-75 Ability to follow instructions 30 years 75 years Both Individuals undergoing other treatments to alleviate spasticity The administration of pharmacological interventions aimed at reducing spasticity Not having any contraindications to using the TMS device, such as a history of seizures, epilepsy (the person themselves or a first-degree family member), a history of head injury or brain injury, metal in the head (outside the mouth) such as surgical clips, cochlear implants, or welded parts, a history of negative reactions to MRI or TMS, a history of brain-related diseases such as MS or brain tumors, a history of fainting, or a history of severe headaches,pregnancy or conception intention within the last three months, Past use of drugs known to reduce the seizure threshold, such as imipramine, amitriptyline, doxepin, nortriptyline, maprotiline, chlorpromazine, clozapine, foscarnet, ganciclovir, ritonavir, theophylline, phenytidine, ketamine, gamma hydroxybutyrate, amphetamine, cocaine, and recent use of drugs or alcohol I63.9 Cerebral infarction, unspecified Rehabilitation Rehabilitation Intervention group: In order to execute the intervention, the patient assumes a supine position. The head is positioned upon the pillow, aligned with the midline. The arms are slightly abducted, with the elbows slightly flexed and the forearms in a supinated position. The anterior aspect of the arm is sterilized using alcohol. Subsequently, within the dry needling group a sterile needle measuring 0.3 x 0.5 is employed by the Fast-in and Fast-out conical technique to administer needling to the biceps brachialis and brachialis muscles for a duration of one minute. The biceps brachii and brachialis muscles are penetrated at a distance of 2 centimeters out of the point where the upper three-fourths and lower one-fourth of the line connecting the coracoid process to the medial epicondyle of the humerus intersect. Control group: instead of dry needles, sham needles will be employed to target the same muscle groups as previously mentioned. Sham needles have a relatively wide edge that solely induces skin irritation without penetrating the dermal layer. Corticospinal excitability. Timepoint: prior to the commencement of the intervention, after three sessions of the intervention, and one week subsequent to the intervention. Method of measurement: The transcranial magnetic stimulation device is utilized to measure the resting motor threshold in elbow flexor muscles while simultaneously recording the corresponding motor-evoked potential via electromyography. Spasticity of the elbow flexor muscles. Timepoint: prior to the commencement of the intervention, after three sessions of the intervention, and one week subsequent to the intervention. Method of measurement: Modified Modified Ashworth Scale. The active and passive range of motion of the elbow joint. Timepoint: prior to the commencement of the intervention, after three sessions of the intervention, and one week subsequent to the intervention. Method of measurement: The assessment will be conducted utilizing a goniometry. Passive resistance force. Timepoint: prior to the commencement of the intervention, after three sessions of the intervention, and one week subsequent to the intervention. Method of measurement: the hand-held dynamometer. Tehran University of Medical Sciences Approved 2023-06-19 Ethics committee of Tehran University of Medical Sciences School of Rehabilitation Sciences, Enghelab Ave., Tehran tehran Tehran Iran (Islamic Republic of)