The purpose of this study was to evaluate the efficacy of acupuncture combined with optimized conventional pharmacological treatment compared with optimized conventional pharmacological treatment alone for chronic pain in adults with chronic kidney disease receiving conservative treatment or renal replacement therapy.
The study was conducted prospectively at a single center. The intervention group received individualized acupuncture in addition to optimized conventional pharmacological treatment. Acupuncture was administered weekly for approximately four months, with 16 sessions planned and a minimum of 10 sessions considered necessary for efficacy evaluation. The comparison group received optimized conventional pharmacological treatment alone, with monthly follow-up over approximately four months.
The original protocol planned simple 1:1 randomization using a computer-generated sequence. During recruitment, some eligible participants expressed a preference for acupuncture before allocation and refused the possibility of receiving conventional pharmacological treatment alone. These participants were allocated to the acupuncture group regardless of the planned random sequence. Participants without an expressed preference were allocated using the planned sequence. Therefore, actual allocation was not exclusively randomized.
The original protocol included patients receiving conservative treatment or peritoneal dialysis. An amendment approved on September 25, 2025, added patients receiving hemodialysis. The first hemodialysis participant was enrolled on September 29, 2025, after approval of the amendment.
