Comparison of the clinical and immunological effectiveness of laser acupuncture, manual acupuncture, and sham in the treatment of knee osteoarthritis

Comparison of clinical and immunological effectiveness of laser acupuncture versus manual acupuncture and routine drug treatment in patients with knee osteoarthritis referred to the rheumatology clinic of Ghaem Hospital

This is a Phase 2, randomized, single-blind, parallel-group, controlled clinical trial involving 90 patients. Randomization will be performed using blocks of six, with the allocation sequence generated via the Sealed Envelope website. The process involves 16 blocks of six—each containing two instances of letters A, B, and C—assigned to numbers 1 through 90. The letters will be placed inside opaque envelopes corresponding to these numbers; the envelope will be sealed with the number written on the outside. Participants will select envelopes sequentially, starting with number 1, and will be assigned to the corresponding group upon opening the envelope, thereby ensuring equal distribution across the three groups.

After reviewing the inclusion criteria and filling out the informed consent form, patients are referred by a rheumatologist from the Rheumatology Clinic of Ghaem Hospital to the Acupuncture Clinic of Imam Reza Hospital in Mashhad and are randomly assigned to one of the three study groups. Blinding is fully described in the relevant section.

Patients 45 years and older Having the diagnostic criteria of the American College of Rheumatology Complaint of knee pain for more than 3 months Last 6 months radiology: Grade 2 or 3 Kellogg Lawrence Medial tibiofemoral osteoarthritis more than lateral in at least one knee NSR 4 or more Not taking omega-3 and glucosamine during the study Not having undergone physical therapy in the past three months No other concomitant rheumatic disease Willingness to sign informed consent

Manual acupuncture, laser acupuncture, laser sham control

Pain, knee joint function and stiffness, blood levels of immunological factors, quality of life, need for painkillers

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.

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.