Randomization and blinding
A total of 392 eligible participants were divided into two groups: the LM group and the sham LM group. The allocation of patients to these groups was determined through a computer-generated randomization sequence. The subjects were assigned numbers based on the order in which they completed the forms. A statistician generated a random sequence of numbers using the seed number 2605 in the STATA/SE11 software. The random sequence comprised random numbers, which were then sorted either in ascending or descending order based on their magnitude. The original codes associated with the sorted order were utilized as the basis for grouping. In order to maintain the confidentiality of this randomization process, the central randomization system generated letter codes (designating either LM equipment or sham LM equipment), which were then transmitted to the field coordinator. Once the equipment operator received the equipment code from the current field coordinator, they used the equipment bearing that code to treat the patient. It is important to note that both types of equipment emitted the same red light during operation, making it impossible for the operator to discern which group the equipment belonged to. The entire procedure was closely monitored by the coordinator to ensure that the study adhered to the established protocol. Trained operators administered treatment to both groups in a dedicated room to prevent any communication among patients. Consequently, no one involved in the study, including patients, equipment operators, outcome assessors, study coordinators, and statisticians, was aware of the treatment assignments.