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IRCT20170305032893N4 IRCT 2023-05-02 Mashhad University of Medical Sciences The effect of electroacupuncture in Parkinson's disease - Assess the efficacy of Electroacupuncture vs. Sham Acupuncture on Gait in patients with Parkinson's Disease 2023-04-09 anticipated 60 Complete https://irct.ir/trial/68472 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: The study is conducted in two intervention and sham acupuncture groups. The intervention group receives real acupuncture and the sham acupuncture group does not receive real acupuncture, and special STREITBERGER needles (needles designed for acupuncture control group) are used. It is exactly the same as real acupuncture without inserting needles into the body, Randomization description: Using Randomaizer.com Except for the acupuncturist, everyone, including patients and health personnel, outcome assessors and data analysts, are all blind. First, the random numbers site is asked to divide and present 60 random numbers into two groups, A and B. Group A is the electroacupuncture intervention group and group B is the sham echopuncture group, and only the acupuncture interventional physician is aware of this division. The participants in the study after the referral from the neurologist and the initial assessment and filling out the forms are referred to the acupuncturist to perform the intervention or the sham according according to the assigned number and related group, Blinding description: Participants who do not know the type of intervention and do not know which group they are in. The outcome evaluator also has no knowledge of the type of intervention. The data analyst also only has access to the data and does not know about the groups and the intervention. 3 PARKINSON. Intervention 1: Intervention group: Acupuncturist will perform acupuncture at predetermined and identical points for all participants in this group. And then the electrodes of the electroacupuncture device are connected to the needles for 20 minutes with an intensity of 1-3 mA and a frequency of 2-100 Hz. It is done twice a week for 4 weeks. Intervention 2: Control group: Special Streitberger needles are used, which gives the patient exactly the sensation of true acupuncture, but the needle does not penetrate the skin. And it is performed by an acupuncturist in the non-acupuncture points . Also, similar to the intervention group, the electrodes of the electroacupuncture device are connected to the needles, but no current is established. Yes - There is a plan to make this available What will be shared: Study specific information When: After completing the study and publish the result To whom: Project supervisors and persons who have permission from the University Research Council Conditions: Only monitoring and not personal and research exploitation Where to obtain: Academic council of the university How to obtain: Obtaining the opinion of the research council of the university and obtaining the favorable opinion of the researcher Comments:
public Babak Asadzadeh
Faculty of Iranian and Complementary Medicine. Second Floor. Faculty of Medicine. East Gate of Ferdowsi University. Mashhad. Khorasan Razavi
mashhad Iran (Islamic Republic of) 9177899191 +98 51 3855 2189 asadzadehb991@mums.ac.ir Mashhad University of Medical Sciences scientific Ali Khorsand vkilzadeh
Faculty of Iranian and Complementary Medicine. Second Floor. Faculty of Medicine. East Gate of Ferdowsi University. Mashhad. Khorasan Razavi
mashhad Iran (Islamic Republic of) 9177899191 +98 51 3855 2189 khorsanda@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Men/Women with parkinson diagnosis- walk for at least 10 meters without help-disease stable condition and no need to change dosage for two months-able to fillout consent form- no history of tratment of acupuncture fixed classic medicine regime treatment-parkinson with movment disorder- Hohen$Yar scale 1 to4 no limit no limit Both Gait disorder other than parkinson Life-threatening conditions, mental disorder, alcohol /drug abuse Electrical device/skin diseases interfere with electroacupuncture Change of drug dose /type for any reason during the study period Belonephobia Coagulation disorder and anticoagulant use Failure to cooperate in intervention for more than two sessions Pregnancy Patients with cardiac arrhythmia History of dementia or stroke History of cognitive disorders History of postural hypotension Neurological diseases such as Huntington's disease/MS, ALS History of epilepsy Acupuncture intolerance Having DBS(deep brain stimulation) G20 Parkinson's disease Treatment - Devices Treatment - Devices Intervention group: Acupuncturist will perform acupuncture at predetermined and identical points for all participants in this group. And then the electrodes of the electroacupuncture device are connected to the needles for 20 minutes with an intensity of 1-3 mA and a frequency of 2-100 Hz. It is done twice a week for 4 weeks. Control group: Special Streitberger needles are used, which gives the patient exactly the sensation of true acupuncture, but the needle does not penetrate the skin. And it is performed by an acupuncturist in the non-acupuncture points . Also, similar to the intervention group, the electrodes of the electroacupuncture device are connected to the needles, but no current is established. The primary outcome includes the measurement of gait parameters :single support time , double support time , swing time , velocity , cadence ,stride length , stride time. Timepoint: Start of study, fourth week,twelfth week. Method of measurement: Video recording of walking and data analysis. Sleep problems based on the MDS-UPDRSI questionnaire. Timepoint: At the beginning of the study and week 4 and week 12. Method of measurement: questionnaire. Constipation problems based on the MDS-UPDRSI questionnaire. Timepoint: At the beginning of the study and week 4 and week 12. Method of measurement: questionnaire. Fatigue based on the MDS-UPDRSI questionnaire. Timepoint: At the beginning of the study and week 4 and week 12. Method of measurement: questionnaire. Mashhad University of Medical Sciences Approved 2022-11-06 Ethics Committee of Mashhad University of Medical Sciences Razavi Khorasan Province, Mashhad, Daneshgah Ave mashhad Razavi Khorasan Iran (Islamic Republic of)