Manual Acupuncture for Intradialytic Fatigue in CKD Patients

Fatigue is multidimensional, driven by anemia, chronic inflammation, metabolic acidosis, muscle wasting, sleep disturbances, and depression, and it is associated with increased morbidity and mortality. Intradialytic fatigue, a highly prevalent symptom affecting 60-97% of chronic kidney disease patients undergoing routine hemodialysis. Current management-erythropoiesis-stimulating agents, sodium bicarbonate, L-carnitine, antidepressants, exercise, and cognitive behavioral therapy-is often limited by inconsistent efficacy, side effects, and high cost. Acupuncture is a safe, low-risk non-pharmacological option, but no Indonesian study has tested manual acupuncture for intradialytic fatigue using the Brief Fatigue Inventory (BFI). Manual acupuncture is performed at bilateral PC6 (Neiguan), ST36 (Zusanli), and KI3 (Taixi) using sterile Huanqiu® needles (0.25 × 25 mm) inserted 20 mm deep through a hole in a transparent waterproof Onemed® plaster, guided by a 20-mm tube. Needles are retained for 20 minutes without manipulation and then removed, twice per treatment period. The sham group receives identical preparation but with blunt-tipped needles that only press against an intact plaster without penetrating the skin, controlling for pressure sensation and expectation. Both groups are blindfolded during the procedure. This is a single-blind, randomized, placebo-controlled crossover clinical trial conducted from October to November 2026 at the Hemodialysis Installation of RSU Kabupaten Tangerang. Participants are chronic kidney disease patients on routine twice-weekly hemodialysis for at least six months who experience intradialytic fatigue. Subjects are randomized by simple randomization into two sequence groups (A: manual then sham; B: sham then manual), with a one-week washout between periods. Blinding is applied to subjects and outcome evaluators, while the acupuncturist performing the intervention is unavoidably aware of group allocation. After eligibility screening and informed consent, participants complete two treatment periods separated by a one-week washout. Each period includes two hemodialysis sessions (days 1 and 4), with acupuncture or sham administered one hour after dialysis begins. BFI assessments are taken at dialysis start (pre-treatment) and one hour after dialysis ends (post-treatment) on each study day. Group A receives manual acupuncture in week 1 and sham in week 3; Group B receives the reverse sequence. Subjects are instructed not to receive any other acupuncture during the study. The primary outcome is the change in fatigue score measured by the Indonesian version of the Brief Fatigue Inventory (BFI), a nine-item instrument using 0-10 numeric scales that assesses fatigue severity (current, usual, worst in 24 hours) and interference with general activity, mood, walking, work, relationships, and enjoyment of life. Secondary outcome is the incidence and percentage of adverse events, including pain, bleeding, hematoma, syncope, infection, or other reported complaints. BFI is assessed by an independent trained evaluator at dialysis start and two hour after dialysis ends on each study day. Data are processed with SPSS version 26. Categorical variables (sex, education) are presented as frequencies and percentages; numeric variables are tested for normality with Shapiro-Wilk and reported as mean ± SD or median (min-max) accordingly. Paired comparisons within subjects use paired t-test or Wilcoxon test, while between-group comparisons use independent t-test or Mann-Whitney test. Statistical significance is set at p \< 0.05. The crossover design allows within-subject comparison, increasing statistical power and reducing inter-individual variability.