NCT07887607Not yet recruiting
Acupuncture for Symptom Burden and Quality of Life in Patients With End-Stage Kidney Disease
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
Source: ClinicalTrials.gov · Last updated 21 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- First submitted
- 8 Oct 2026
- Start date
- Dec 2026
- Primary completion date
- Jun 2029
- Lead sponsor
- University General Hospital of Heraklion
- Diseases
- Chronic kidney disease
- NCT number
- NCT07887607
What you commit to
- Study type: Interventional
- Planned participants: 160
- From Dec 2026 to the primary completion date, Jun 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current or recent (within the previous 3 months) use of high-dose systemic opioids (\>100 mg morphine milligram equivalents \[MME\]) or initiation/significant modification of antidepressant or antiepileptic medication used for analgesia within 4 weeks prior to enrollment.
- Regular acupuncture treatment within the previous 6 months.
Other illness
- Active infection, decompensated heart failure (NYHA class IV), recent acute coronary syndrome (ACS), or any other serious acute illness that could interfere with study participation.
- Pregnancy, cognitive impairment, or severe psychiatric illness that may interfere with the valid completion of study questionnaires.
Lab values
- Severe thrombocytopenia (platelet count \<50,000/μL) or coagulation disorders (e.g., INR \>1.5 or other known coagulation disorder) constituting a contraindication to acupuncture.
Who the study is looking for
- Age ≥18 years.
- Diagnosis of end-stage kidney disease (ESKD) requiring chronic kidney replacement therapy:
- Hemodialysis for ≥3 months and/or
- Peritoneal dialysis for ≥3 months.
- Stable treatment regimen (dialysis frequency/duration and analgesic therapy) for at least 4 weeks prior to enrollment.
- Adequate understanding of the Greek language and ability to understand and provide written informed consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University General Hospital of Heraklion (PAGNI) Coordinator of this site? Confirm its status | Heraklion | Greece | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.