Management and safety monitoring
CRF
CRF
Before the initiation of this trial, the feasibility and innovation of this protocol have been discussed comprehensively in the seminar composed of five authoritative experts in the field. Then, the task will be divided, and the relevant personnel should receive training. To prevent treatment bias, all the staff including doctors, physiotherapists, group allocation workers, data collectors, data registers, and data processing analysts need to be trained in advance on the tasks they are responsible for. Participants are all anonymous in this trial, and their demographic information will be stored in a Word file with a password kept by the manager, and their trial data will be recorded in another Word file by relevant staff without any participants’ information. If there is any special circumstance, all trial personnel should be informed in advance, and approval should be obtained before checking the participants’ relevant records. The project manager, researchers, and experts from the Ethics Committee of the Second Affiliated Hospital of Heilongjiang University of Chinese Medicine are mainly responsible for the quality control of these trials.In order to achieve the ability of standard operation procedure (SOP), filling in of case report form (CRF), Electronic Data Capture (EDC) system, and data entry. All data will be accurately double-entered into the EDC system, and the electronic CRF will be identical to the paper CRF. Moreover, multiple imputation will be used to deal with the missing data as part of the sensitivity analysis.