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Acupuncture for Symptom Burden and Quality of Life in Patients With End-Stage Kidney Disease
Sponsor: University General Hospital of Heraklion
Summary
Patients with end-stage kidney disease (ESKD) undergoing hemodialysis or peritoneal dialysis experience a high burden of symptoms, including fatigue, pain, pruritus, muscle cramps, and sleep disturbances, which substantially affect health-related quality of life (HRQOL). Although acupuncture has shown potential benefits for several symptoms in this population, evidence regarding its overall effect on HRQOL remains limited, and the underlying biological mechanisms are not fully understood. This prospective, randomized, sham-controlled trial will evaluate the effect of a structured acupuncture protocol on HRQOL and symptom burden in patients with ESKD undergoing hemodialysis or peritoneal dialysis. Participants will be randomized to receive either acupuncture or sham acupuncture in addition to usual care. HRQOL will be assessed using the Kidney Disease Quality of Life 36-item questionnaire (KDQOL-36), while secondary clinical outcomes will assess key dimensions of symptom burden. The study will also investigate changes in selected neuropeptide and proteomic biomarkers associated with pain modulation, neuroinflammation, and neuroendocrine regulation. By integrating patient-reported clinical outcomes with biomarker assessment, the study aims to explore both the clinical effects of acupuncture and the biological mechanisms potentially underlying these effects in patients with ESKD.
Official title: Effect of a Structured Acupuncture Protocol on Symptom Burden, Quality of Life, and Neuropeptide Biomarkers in Patients With End-Stage Kidney Disease Undergoing Hemodialysis or Peritoneal Dialysis: A Prospective, Randomized, Blinded, Sham-Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
160
Start Date
2026-12
Completion Date
2029-09
Last Updated
2026-10-21
Healthy Volunteers
No
Conditions
Interventions
Acupuncture
Body acupuncture will be administered using sterile, single-use needles, with needles retained for 30 minutes. The standardized core acupuncture points will include bilateral LI4, ST36, SP6, LV3, KI3, and BL23. Up to two additional points (KI7, KI10, KI6, CV4, or CV6) may be selected according to the participant's clinical presentation and Traditional Chinese Medicine assessment, and up to two local trigger points may be used for musculoskeletal pain when indicated. Mild deqi will be elicited at the main acupuncture points, avoiding vigorous needle manipulation. Auricular acupuncture with sterile semi-permanent needles may also be used for 3-4 days. Treatment will consist of 2-3 sessions per week, for up to 24 sessions over 8-12 weeks. Acupuncture points on the limb with an arteriovenous fistula or graft and areas near the vascular access will be avoided.
Sham Acupuncture
Sham acupuncture will be administered at non-acupuncture points located away from recognized acupuncture points and major neurovascular structures. Needles will be inserted superficially (1-2 mm), without elicitation of deqi, needle manipulation, or electrical stimulation. The sham procedure will mimic the active acupuncture intervention with respect to treatment setting, participant positioning, session duration, and treatment frequency in order to maintain participant masking. Participants will continue to receive their usual care without modification.
Locations (1)
University General Hospital of Heraklion (PAGNI)
Heraklion, Greece