However, experiments in the literature are usually based on small number of participants, unclear randomization (researchers do not use validated methods of randomization such as a computer or marked envelopes, only physician decides the allocation of participants), lack of inclusion and exclusion criteria, and no assessment of the safety of NMES application in sport [ 11, 13, 14, 19].
Additional limitations include the short duration of the study and the small number of patients following randomization.
Limitations of our trial include the small number of evaluable patients, absence of randomization to continue cetuximab or change therapy based on the tumor response to cycle 1 assessed by CT or FDG-PET/CT, and single-institution experience.
Although the published reports usually included a small number of patients and lacked randomization and a placebo-controlled group, these clinical studies still provide great advances in managing voiding dysfunction in young men.
The study presents certain limitations: the main limitations are the rather small number of participants and the incomplete randomization.
However, flaws in the study design (namely, a small number of patients and an undefined randomization procedure with the use of different cooling techniques and doses of dantrolene sodium, which were non-blinded to clinicians) raise doubts about the scientific validity of the results.
While we did not appreciate important clustering effects, our trial has all the challenges of clustered-randomized trials in that the small number of clusters reduces the likelihood that randomization will achieve balanced prognosis.
The small number of patients treated and the lack of randomization (not usable in this case due to the predetermined different selection criteria) are also weak points of this study.
Small differences in baseline values can cause spurious conclusions with small numbers of units of randomization if only end values are presented rather than change values.
Limitations of that study are the small number of patients included, open design, and lack of randomization.
