Prevent it from happening? If it is to abolish, everytime pt will have to underwent your procedure? If it is to prevent, is it one time for the life?

Is this condition unberable so they have to see a doctor? Or is it just annoying?

All my questions are to query necessary info to see I can help design the study.

It is hard without knowing much about the condition. If you can give a description aout the condition in amedical way without revealing it, it'll be helpful.

Setting up a good control is the key. It could be non-treatment, or medically treated group if you claim your procedure is more favorable. I'd also love to know in what way it is more favorable.

Study can also be dsigned for a combination therapy compared with single modlity in the future once you effective is established.

The outcome, is complete or partial alleviatuon of that feeling. Souds like your claim is partial. There might be role of conbination therapy.

The measureMent is the grading score.

The inclusion critrior will be very tricky and critical. If you are able to grade, e.g. In a scale of 5, I would only select grade 4 only. Because it is subjective, the extremes are not reliable. Choose pts of same level of severity allows you to compare your "score changes" with less bias, because the amptitude of change may be different from grade 5 and grade 1. Grade 1 just doesn't have equal room to improve as grade 5.

Other point to consider when choosing patients.

these are the group of population you hav e to think:patients who tolerates the "feeling " well and never sought medical help, patients who tried medicatioin but never worked or not satisfied and thus give trying medication, and pts who always use medicatiosan because it helps albeit limited. Depending on your goal of study, you choose different group of people. Try to limit your subjects to an identical group.

Once inclusion criterior is set, then recruit, and randomized into two groups.

These are generic principles.