An interventional study of Acupuncture and Sham Acupuncture in End Stage Kidney Disease (ESKD), sponsored by University General Hospital of Heraklion. Not yet recruiting at 1 site in Greece. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by University General Hospital of Heraklion · Not applicable, Interventional, and Treatment
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.
2,121 studies on the registry are indexed under Kidney Failure, Chronic; 264 are open to participants now.
This study's planned enrollment of 160 is above the median of 55 across 1,582 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →University General Hospital of Heraklion is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Diagnosis of end-stage kidney disease (ESKD) requiring chronic kidney replacement therapy:
Exclusion Criteria:
Participants will receive a structured acupuncture protocol in addition to usual care. Treatment will consist of 2-3 sessions per week for up to 24 sessions over 8-12 weeks. The protocol will include a standardized core set of acupuncture points, with limited individualized additional points based on clinical presentation and Traditional Chinese Medicine assessment. Body acupuncture and auricular acupuncture may be used. Acupuncture will be performed by trained members of the research team at the University General Hospital of Heraklion.
Other: Acupuncture
Participants will receive sham acupuncture in addition to usual care, with the same treatment frequency, session duration, and general procedural setting as the experimental group. Sham acupuncture will be performed at non-acupuncture points using superficial needle insertion (1-2 mm), without elicitation of deqi, needle manipulation, or electrical stimulation. No modification of usual care will be made as part of the sham intervention.
Other: Sham 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 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.
Change in health-related quality of life assessed by KDQOL-36 domain scores
Health-related quality of life will be assessed using the Kidney Disease Quality of Life 36-item questionnaire (KDQOL-36). The instrument includes the SF-12 Physical Component Summary (PCS) and Mental Component Summary (MCS), as well as three kidney disease-specific domains: Symptoms and Problems, Effects of Kidney Disease, and Burden of Kidney Disease. Scores are transformed to a 0-100 scale, with higher scores indicating better health-related quality of life. The KDQOL-36 will be administered at baseline, at week 6, at the end of the 12-week intervention, and at the 12-week post-intervention follow-up (24 weeks). Changes over time will be compared between the acupuncture and sham acupuncture groups.
Time frame: Baseline, week 6, week 12, and week 24
Change in handgrip strength
Handgrip strength will be measured as an objective assessment of functional capacity. Changes over time will be compared between the acupuncture and sham acupuncture groups.
Time frame: Baseline, week 6, week 12, and week 24
Change in individual symptom scores assessed by the ESAS-r
Symptom burden will be assessed using the revised Edmonton Symptom Assessment System (ESAS-r). The intensity of each symptom will be rated separately on a numerical scale from 0 to 10, with higher scores indicating greater symptom intensity. Changes in individual symptom scores over time will be compared between the acupuncture and sham acupuncture groups.
Time frame: Baseline, week 6, week 12, and week 24
Change in Pittsburgh Sleep Quality Index (PSQI) global score
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The PSQI global score ranges from 0 to 21, with higher scores indicating poorer sleep quality. The validated Greek version will be used. Changes in global scores over time will be compared between the acupuncture and sham acupuncture groups.
Time frame: Baseline, week 6, week 12, and week 24
Change in Brief Pain Inventory (BPI) pain interference score
The impact of pain on daily functioning will be assessed using the pain interference subscale of the Brief Pain Inventory (BPI). The pain interference score ranges from 0 to 10, with higher scores indicating greater interference of pain with daily activities. Changes over time will be compared between the acupuncture and sham acupuncture groups.
Time frame: Baseline, week 6, week 12, and week 24
Change in pressure pain threshold assessed by algometry
Pressure pain threshold will be measured using an algometer as an exploratory assessment of mechanical pain sensitivity. Higher pressure pain threshold values indicate lower mechanical pain sensitivity. Changes over time will be compared between the acupuncture and sham acupuncture groups.
Time frame: Baseline, week 6, week 12, and week 24
Change in 5-D Itch Scale total score
Pruritus will be assessed using the 5-D Itch Scale, which evaluates five dimensions: duration, degree, direction, disability, and distribution. The total score ranges from 5 to 25, with higher scores indicating greater pruritus burden. The validated Greek version will be used. Changes over time will be compared between the acupuncture and sham acupuncture groups.
Time frame: Baseline, week 6, week 12, and week 24
Change in circulating beta-endorphin concentration
Circulating beta-endorphin levels will be measured in peripheral blood samples collected at four predefined time points: baseline (T0), week 6 (T1), week 12 (T2), and week 24 (T3). Changes over time will be compared between the acupuncture and sham acupuncture groups.
Time frame: Baseline, week 6, week 12, and week 24
Change in circulating Substance P concentration
Circulating Substance P concentration will be measured in peripheral blood samples collected at four predefined time points: baseline (T0), week 6 (T1), week 12 (T2), and week 24 (T3). Changes over time will be compared between the acupuncture and sham acupuncture groups.
Time frame: Baseline, week 6, week 12, and week 24
Change in circulating calcitonin gene-related peptide (CGRP) concentration
Circulating calcitonin gene-related peptide (CGRP) concentration will be measured in peripheral blood samples collected at four predefined time points: baseline (T0), week 6 (T1), week 12 (T2), and week 24 (T3). Changes over time will be compared between the acupuncture and sham acupuncture groups.
Time frame: Baseline, week 6, week 12, and week 24
Change in serum proteomic/peptidomic profile
Exploratory serum proteomic/peptidomic analyses will be performed before and after the treatment cycle to investigate changes in the serum proteomic/peptidomic profile following the intervention.
Time frame: Baseline and end of intervention (up to 12 weeks)
Plan to share: No — Individual participant data will not be made publicly available or shared with external researchers. Study results will be reported in aggregate form, ensuring that individual participants cannot be identified, in accordance with the approved study protocol, informed consent procedures, and applicable data protection regulations.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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University General Hospital of Heraklion