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IRCT20170305032893N3 IRCT 2023-05-02 Mashhad University of Medical Sciences Effectiveness of acupuncture in osteoarthritis The survey of the effects of Manual and Electro- Acupuncture on the clinical manifestations and cytokines of immune system in patients with knee osteoarthritis and comparing it with sham acupuncture 2023-04-09 anticipated 45 Complete https://irct.ir/trial/68471 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Online version of the list of random numbers through Research randomizer, Blinding description: Except for the acupuncturist, everyone, including the patients and health personnel, and the outcome assessor and data analyzer, are all blind .First, the randomizer numbers site is asked to divide and present 45 random numbers in three groups A, B and C. Group A is the manual intervention group, and group B is the electrical intervention group, and group C is the sham acupuncture group, and only the acupuncturist intervener is aware of this division .The numbers are placed in sealed envelopes, and after being accepted into the study, the patients refer to the allocator person and take an envelope and refer to the acupuncturist, and after registering the envelope and patient's details, the intervention is performed. N/A Knee Osteoarthritis. Intervention 1: Intervention group 1: manual acupuncture group. In this group, acupuncture needles of specific size are used in predetermined and identical points and are stimulated by hand every ten minutes. Intervention 2: Control group: Sham acupuncture is performed in the control group, which is actually false. Special Streitberger needles are used, which are placed on the skin. There is a tingling sensation, but the needle does not enter the skin, and the points are the same as in the intervention group. Intervention 3: The intervention group 2: In this group, electro-acupuncture is used. The points and needles are the same as the previous group, only the stimulation is done through an electro-acupuncture device with specific voltage and current intensity. Yes - There is a plan to make this available What will be shared: Study specific information When: After completing the study and publication of results To whom: Project supervisors and persons who have permission from the University Research Council Conditions: Project supervisors and persons who have permission from the University Research Council Where to obtain: University Research Council How to obtain: Obtaining the opinion of the research council of the university and obtaining the favorable opinion of the researcher Comments:
public َAhmad Hamzeh
The east door of the Ferdowsi university - second floor of Faculty of Medicine -- Faculty of Iranian and complementary Medicin
Mashad Iran (Islamic Republic of) 9177899191 +98 51 3855 2189 hamzeha991@mums.ac.ir Mashhad University of Medical Sciences scientific Dr. Ali Khorsand vakilzadeh
The east door of the Ferdowsi university - Faculty of Medicine - the second floor.faculty of iranian and complimentary medicine
Mashhad Iran (Islamic Republic of) 9177899191 +98 51 3855 2189 khorsanda@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients diagnosed with knee OA based on ACR criteria (ACR=American college of Rheumatology )( OA=Osteoarthritis ) Age should be between 45 and 65 years old Only one knee is involved Have a VAS pain score of four or more than four.(VAS=visual Analogue scale ) Be literate (writing and reading ability) 45 years 65 years Both The surgery has been detailed or is in the process of surgery Knee arthroscopy has been done during the last year Have an intra-articular injection during the last six months Any disease that disrupts the functioning of the immune system, such as inflammatory diseases, autoimmune diseases, connective tissue diseases, diabetes, cancer, etc. Severe physical or cognitive illness of the participant that prevents the continuation of cooperation Have a pacemaker Pregnancy and breastfeeding Have done acupuncture during the last six months Coagulation disorders and the use of anticoagulants Participation of the candidate in other clinical studies currently or during the last three months Getting infected with covid during the study or ... in the last month or other infectious diseases during the struggle . BMI more than 30 (BMI =body mass index ) Any forced changes in treatment regimen Non-cooperation in applying intervention for more than two sessions If the joint has liquid effusion (joint effusion) Life-threatening medical and clinical events Extreme fear of needles( Belonephebia) M17 Osteoarthritis of knee Treatment - Devices Treatment - Devices Treatment - Devices Intervention group 1: manual acupuncture group. In this group, acupuncture needles of specific size are used in predetermined and identical points and are stimulated by hand every ten minutes. Control group: Sham acupuncture is performed in the control group, which is actually false. Special Streitberger needles are used, which are placed on the skin. There is a tingling sensation, but the needle does not enter the skin, and the points are the same as in the intervention group. The intervention group 2: In this group, electro-acupuncture is used. The points and needles are the same as the previous group, only the stimulation is done through an electro-acupuncture device with specific voltage and current intensity. Primary outcome 1) changes in the level of pain based on the VAS scale before the intervention and weeks 8, 12, and 16.--- . 2) Measuring the amount of inflammatory factors: including IFN-γ (gama interferon )secreted by T-helper1 cells, IL-4 ( interleukin-4 ) secreted by T-helper-2 cells. -- and TGF-β ( transforming growth factor beta ) and IL10 ( interleukin 10 )secreted by regulatory T cells (T REG CELLS), and TNFα (tumor necrosis factor alpha )secreted by M1 macrophages before and after treatment at the end of weeks 8 . Timepoint: 0-8-12-16 weeks. Method of measurement: Based on numerical scale of vas and based on laboratory numerical values. Changes in the level of physical activity. Timepoint: Before intervention and weeks 8, 12 and 16. Method of measurement: WOMAC Scale( Western Ontario McMaster Universities Osteoarthritis Index). Changes in morning stiffness. Timepoint: Before intervention and weeks 8, 12 and 16. Method of measurement: WOMAC Scale. Changes in quality of life. Timepoint: Before intervention and weeks 8, 12 and 16. Method of measurement: Based on the quality of life form (QoL ). Mashhad University of Medical Sciences Approved 2023-01-30 Ethics Committee of Mashhad University of Medical Sciences Qureshi Building, University Street, Mashhad Khorasan razavi Mashhad Razavi Khorasan Iran (Islamic Republic of)