Following confirmation of the patient's eligibility (based on the inclusion criteria) and obtaining informed consent, baseline assessments including age and BMI will be performed to determine the relevant stratum. The block randomization list (with blocks of 4, comprising six possible sequences: AABB, ABAB, ABBA, BBAA, BABA, BAAB) will be generated in advance, separately for each stratum, by an independent individual who has no role in the visits, treatment, or assessment of patients. (A represents the first group and B represents the second group.)
The result of this pre-determined allocation is placed in opaque, sealed envelopes, numbered sequentially in order of enrollment. When each eligible patient enters the study, the enrolling researcher (who has no knowledge of the content of the randomization list) opens the next envelope corresponding to that patient's stratum, in order, and the patient is assigned to the IASTM or Sham IASTM group according to the code inside the envelope.
In this way, patients enter the randomization list sequentially, with no possibility of predicting the assigned group before the envelope is opened, and the process of sequence generation (by the independent individual) is kept completely separate from the process of allocation implementation (by the enrolling researcher).