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IRCT20200913048706N1 IRCT 2021-01-14 Tehran University of Medical Sciences The effect of dry needling technique on spasticity and function in stroke patients Comparison of the short term effects of wrist flexor dry needling versus LI4 & TE5 acupuncture points dry needling on upper limb spasticity and function, in stroke patients: A Double-Blinded Randomized Clinical Trial 2020-10-26 anticipated 20 Complete https://irct.ir/trial/52090 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: According to the number of patients in each group, the particular sort of treatment, either "wrist flexor dry needling" or "LI4&TE5 acupuncture points dry needling," is written on a piece of paper, and the paper is placed in Opaque sealed envelopes. The envelopes are then mixed. At the first visit session of each individual, the therapist who will not be involved in outcomes assessment will randomly select one of the envelopes. Based on the written sort of treatment specified, the therapist will do the patient's particular treatment. If any of the patients, for any reason, is omitted from the study, one envelope with the particular topic will be added again by the examiner, and they will be mixed again, Blinding description: Although at first, the necessary explanation about the aims of the project and the existence of two groups are given to the patients, no explanation is given to them about the difference between the treatment methods. Besides, the patient's treatment sessions will be arranged so that the two groups' patients have no contact with each other and are not aware of the other group's treatment method. In this way, patients are blind regarding the treatment method. In addition, the allocation of participants into each of the treatment groups will be done by the therapist who performed the DN, and their clinical evaluation will be performed by another examiner who is not aware of the treatment group. So the examiner also is blind to the specific treatment method of each participant. N/A Stroke. Intervention 1: Intervention group 1:wrist flexor dry needling including flexor carpi ulnaris and flexor carpi radialis in supine position and forearm in supination with filiform needles. The technique is done in the Fast in - Fast out method for one minute for each muscle / point. The number of treatment sessions is three sessions during a week. Intervention 2: Intervention group 2: LI4 & TE5 acupuncture points dry needling in supine position and forearm in pronation with filiform needles. The technique is done in the Fast in - Fast out method for one minute for each muscle / point. The number of treatment sessions is three sessions during a week. Yes - There is a plan to make this available What will be shared: The raw data of research and its analysis will be available to researchers if they request it. When: After the publication of articles resulting from the research. To whom: Researchers working in academic institutions. Conditions: The data are available only to other researchers to study and evaluate treatment outcomes. Where to obtain: By sending an email to the corresponding author. How to obtain: Sending an Email to the corresponding author and request the data. Comments:
public Najmeh Nazari
Physiotherapy Department, School of Rehabilitation, Pich-e-Shemiran., Enghelab St.
Tehran Iran (Islamic Republic of) 11489-65111 +98 21 7753 5132 Najmeh_Nazari@outlook.com Tehran University of Medical Sciences scientific Najmeh Nazari
Physiotherapy Department, School of Rehabilitation, Pich-e-Shemiran., Enghelab St
Tehran Iran (Islamic Republic of) 11489-65111 +98 21 7753 5132 Najmeh_Nazari@outlook.com Tehran University of Medical Sciences Iran (Islamic Republic of) Age ≥18 years old First-ever stroke resulted in hemiplegia Disease duration of at least six months Wrist flexor Modified Modified Ashworth Scale (MMAS) spasticity score ≥1 Active and passive range of motion of the involved wrist is at most 10% less than the non-involved side 18 years no limit Both Have neurological disorders or diabetes Inability to follow the therapist's instructions Have contraindications to Dry Needling Have participation simultaneously in another clinical trial Have injections with botulinum toxin in the 6 months preceding the study Taking antispastic drug G46.3 Brain stem stroke syndrome Rehabilitation Rehabilitation Intervention group 1:wrist flexor dry needling including flexor carpi ulnaris and flexor carpi radialis in supine position and forearm in supination with filiform needles. The technique is done in the Fast in - Fast out method for one minute for each muscle / point. The number of treatment sessions is three sessions during a week. Intervention group 2: LI4 & TE5 acupuncture points dry needling in supine position and forearm in pronation with filiform needles. The technique is done in the Fast in - Fast out method for one minute for each muscle / point. The number of treatment sessions is three sessions during a week. Spasticity. Timepoint: Before intervention, immediately after intervention, and one week after intervention. Method of measurement: Modified Modified Ashworth Scale. Function. Timepoint: Before intervention, immediately after intervention, and one week after intervention. Method of measurement: Fugl-Meyer assessment. Active Range Of Motion(ROM). Timepoint: Before intervention, immediately after intervention, and one week after intervention. Method of measurement: Goniometer. Passive Range Of Motion(ROM). Timepoint: Before intervention, immediately after intervention, and one week after intervention. Method of measurement: Goniometer. Tehran University of Medical Sciences Approved 2020-10-18 Ethics committee of Nursing and Midwifery & Rehabilitation Schools- Tehran University of Medical Sci Quds Ave., Keshavarz Blvd, Tehran Tehran Iran (Islamic Republic of)