The proposed randomized controlled trial protocol will evaluate the effect of acupuncture treatment on the functional capacity (FC) and health-related quality of life (HRQOL) in chronic kidney disease (CKD) with glomerular filtration rate (GFR) category 5 (CKG G5) patients receiving maintenance dialysis. Patients undergoing hemodialysis (HD) from a dialysis center will be randomly assigned to experimental, placebo and control groups. In order to determine the difference between the same number of treatments performed three times or one treatment a week, experimental (verum acupuncture) and placebo (sham acupuncture) groups will receive a total of nine acupuncture treatments; however, both groups will be divided into subgroups A and B. The same selection of acupuncture points will be applied to both experimental subgroups and the placebo subgroups will receive acupuncture on non-acupuncture points. The results will be assessed by the 6-min Walk Test, Handgrip Test, 30-sec Sit-to-Stand and Kidney Disease Quality of Life-Short Form and will be held at baseline, after treatment and 12 weeks post-treatment follow up. This paper describes the rationale and design for a randomized, patient-assessor blinded controlled trial, which may provide evidence for the clinical application of acupuncture in CKG G5 patients undergoing HD.
Keywords: acupuncture; chronic kidney disease; functional capacity; health-related quality of life; hemodialysis; integrative medicine; randomized controlled trial.