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IRCT20110809007265N15 IRCT 2025-11-01 Mashhad University of Medical Sciences Comparison of laser and manual acupuncture in knee osteoarthritis Comparison of the clinical and immunological effectiveness of laser acupuncture, manual acupuncture, and sham in the treatment of knee osteoarthritis 2025-12-22 anticipated 90 Recruiting https://irct.ir/trial/85121 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In the random allocation, we will use blocks of 6 and use the sealedenvelope website. In this type of allocation, 16 blocks of 6 are generated by the system (2 of each letter) and are numbered from 1 to 90. The letters are placed in the order of their numbers in a matte envelope, the number is written on the envelope, and the lid is closed. People start taking the envelope in the order of their arrival from envelope number 1, open it, and are referred to the relevant group. In this way, people are placed equally in three groups. After the blocks are determined, they are placed in envelopes that cannot be seen from the outside, the letters are placed in them, and a number is written in order. People take the envelope in the order of their arrival and are assigned to the relevant group, Blinding description: All patients who enter the study first fill out an informed consent form, which states that the patient will be randomly assigned to one of three study groups: manual acupuncture, laser acupuncture, and the control group. Given that sham laser acupuncture is performed in the control group, patients in the laser acupuncture and control groups will be blinded to receiving the laser acupuncture intervention but will be aware that they will not receive conventional acupuncture. Patients in the manual acupuncture group will also likely notice the difference between this method and laser acupuncture, so blinding can only be done partially for the laser acupuncture and sham laser acupuncture groups. Blinding of the acupuncture specialist (principal investigator) is not possible. The referring rheumatologist, the nurse who takes the blood sample, the immunologist and expert, and the statistician will be responsible for collecting data and evaluating the outcomes for the assigned group of patients. The acupuncture resident responsible for data collection and overall patient follow-up will also be blinded to the assigned patient group. 3 Gonarthrosis [arthrosis of knee]. Intervention 1: First Intervention group: Manual acupuncture twice a week for 8 weeks. Intervention 2: Second Intervention group: Laser acupuncture twice a week for 8 weeks. Intervention 3: Control group: Sham laser twice a week for 8 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No decision has been made yet.
public Dr Hoda Azizi
Shahid Fakouri Blvd., between Shahid Javan Sq. and Al Shahidi Sq., Mashhad, Khorasan Razavi Province
Mashhad Iran (Islamic Republic of) 9177899191 +98 51 3879 5031 AziziH@mums.ac.ir Mashhad University of Medical Sciences scientific Dr Hoda Azizi
Shahid Fakouri Blvd., between Shahid Javan Sq. and Al Shahidi Sq., Mashhad, Khorasan Razavi Province
Mashhad Iran (Islamic Republic of) 9177899191 +98 51 3879 5031 AziziH@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients aged 45 and above Patients with the diagnostic criteria of the American College of Rheumatology Complaint of knee pain for more than 3 months Radiological examination in the last 6 months indicating grade 2 or 3 of Kellgren lawrence with interpretation and confirmation by a respected rheumatologist Patients with medial tibiofemoral osteoarthritis in at least one knee A score of 4 or higher on the NSR Do not consume omega-3 and glucosamine while studying Not undergoing physiotherapy in the past three months At the same time, they should not have another rheumatic disease such as rheumatoid arthritis 45 years no limit Both Previous knee surgery on the knee being evaluated or pending any surgery for both knees Knee pain caused by other pathologies (such as meniscus tear, rheumatoid arthritis, joint space infection, malignancy, gout, lumbosacral diseases with lower limb symptoms, etc.) A history of arthroscopy within the last year or a history of intra-articular injection within the last 6 months for knee evaluation Each of the knees has received acupuncture/physical therapy in the past 6 months Severe acute or chronic organic or neuropsychiatric disorder Coagulation disorders (such as hemophilia) Autoimmune disorders Malignancies Patients with epilepsy or those with a pacemaker Drug use Physiotherapy a month ago Preparation for pregnancy, pregnancy or breastfeeding period Patients who have participated in other acupuncture clinical studies in the past month M17 Osteoarthritis of knee Treatment - Devices Treatment - Devices Placebo First Intervention group: Manual acupuncture twice a week for 8 weeks Second Intervention group: Laser acupuncture twice a week for 8 weeks Control group: Sham laser twice a week for 8 weeks Pain. Timepoint: The trial duration is 16 weeks, including 8 weeks of treatment and 8 weeks of follow-up. Method of measurement: Pain based on Visual Analogue Scale. Knee joint performance status. Timepoint: Before treatment, week 4, week 8, and week 16. Method of measurement: Based on Western Ontario and McMaster Universities Arthritis Index (WOMAC). Knee stiffness. Timepoint: Before treatment, week 4, week 8, and week 16. Method of measurement: Based on Western Ontario and McMaster Universities Arthritis Index (WOMAC). Blood level of immunologic factors VEGF IL23 IL17. Timepoint: Before studying and week 8. Method of measurement: Blood samples from patients will be taken for immunological tests before the study and at week 8. The blood samples will be stored at -80 degrees in the reference lab so they can be used for future studies as well. Quality of life. Timepoint: Before treatment, week 4, week 8, and week 16. Method of measurement: Based on Short Form (36) Health Survey (SF 36). The need for using painkillers. Timepoint: Before treatment, week 4, week 8, and week 16. Method of measurement: Based on the patient's medical history as well as the form listing the painkillers used by the patient. Side effects. Timepoint: Week 4, week 8, and week 16. Method of measurement: Based on the patient's medical history as well as the form about side effects filled out by the patient. Mashhad University of Medical Sciences Approved 2025-06-21 ethics committee of Mashhad University of Medical Sciences Shahid Fakouri Blvd., between Shahid Javan Sq. and Al Shahidi Sq., Mashhad, Khorasan Razavi Province Mashhad Razavi Khorasan Iran (Islamic Republic of)