Randomization and blinding
RECRUITMENT
This was a single-blind randomized clinical trial. A total of 60 subjects were randomly assigned into two groups using the envelope randomization method. Opaque envelopes of the same size were first made and encoded. The treatment regimen was determined by a random sequence generated by the computer and put in the corresponding numbered envelope. Patients were numbered according to the order of enrollment, the envelopes with the same number were opened, and the study was conducted according to the treatment plan contained in the envelopes.In the present study, we used assessment blinding. The evaluator evaluated the findings without knowing the patient assignment, and each patient was evaluated by the same evaluator before and after the intervention to avoid changes within the scorer. Statistical analysis was carried out by persons not involved in recruitment, screening, evaluation, or intervention. In addition, the treatment process was independently performed by therapists who were not involved in information collection, evaluation, and data analysis procedures. To minimize bias and distractions, therapists did not provide patients with any information about the benefits and risks of treatment. An independent staff member oversaw the implementation of the blindfolding. If blinding failed, the patient was excluded from the study protocol.