End Stage Kidney Disease (ESKD)Acup-ESKDNCT07887607
Acupuncture for Symptom Burden and Quality of Life in Patients With End-Stage Kidney Disease
A study testing Acupuncture in people with End Stage Kidney Disease (ESKD), run by University General Hospital of Heraklion at 1 site in Greece.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Kidney Disease (ESKD)
- What is being tested?
- Acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteGreece
- Study dates
- Dec 2026to Sep 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- 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.
- 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.
- Pregnancy, cognitive impairment, or severe psychiatric illness that may interfere with the valid completion of study questionnaires.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site
University General Hospital of Heraklion (PAGNI)
Heraklion, 71110
Kleio G Dermitzaki, +302810392176, ekderm@gmail.com
Dimitra G Ligerou, +302810375445, dimitra.ligerou@gmail.com
About this study
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
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.
- Conditions
- End Stage Kidney Disease (ESKD)
- Being tested
- Acupuncture, Sham Acupuncture
- Keywords
- Acupuncture, Hemodialysis, Peritoneal Dialysis, Health-Related Quality of Life, Symptom Burden, Neuropeptides, Proteomics
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
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 AcupunctureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | 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. Receives: Other: Acupuncture |
| Sham Acupuncture | Sham comparator | 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. Receives: Other: Sham Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, week 6, week 12, and week 24
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and end of intervention (up to 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study startDec 2026 (estimated)
- Primary completionJun 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for End Stage Kidney Disease (ESKD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University General Hospital of Heraklion
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kleio Dermitzaki, University General Hospital of Heraklion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07887607
- Sponsor's protocol ID
- ACUP-ESKD
- Acronym
- Acup-ESKD
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Zhong Z, Sun MM, He M, Huang HP, Hu GY, Ma SQ, Zheng HZ, Li MY, Yao L, Cong DY, Wang HF. Proteomics and its application in the research of acupuncture: An updated review. Heliyon. 2024 Jun 18;10(12):e33233. doi: 10.1016/j.heliyon.2024.e33233. eCollection 2024 Jun 30.
PubMed 39022010Fletcher BR, Damery S, Aiyegbusi OL, Anderson N, Calvert M, Cockwell P, Ferguson J, Horton M, Paap MCS, Sidey-Gibbons C, Slade A, Turner N, Kyte D. Symptom burden and health-related quality of life in chronic kidney disease: A global systematic review and meta-analysis. PLoS Med. 2022 Apr 6;19(4):e1003954. doi: 10.1371/journal.pmed.1003954. eCollection 2022 Apr.
PubMed 35385471Correia de Carvalho M, Pereira Machado J, Laranjeira M, Nunes de Azevedo J, Azevedo P. Effect of Acupuncture on Functional Capacity and Health-Related Quality of Life of Hemodialysis Patients: Study Protocol for a Randomized Controlled Trial. Healthcare (Basel). 2022 Oct 17;10(10):2050. doi: 10.3390/healthcare10102050.
PubMed 36292497Liu S, Zhang F, Bai Y, Huang L, Zhong Y, Li Y. Therapeutic effects of acupuncture therapy for kidney function and common symptoms in patients with chronic kidney disease: a systematic review and meta-analysis. Ren Fail. 2024 Dec;46(1):2301504. doi: 10.1080/0886022X.2023.2301504. Epub 2024 Jan 8.
PubMed 38189090Correia de Carvalho M, Nunes de Azevedo J, Azevedo P, Pires C, Laranjeira M, Machado JP. Effect of Acupuncture on Functional Capacity in Patients Undergoing Hemodialysis: A Patient-Assessor Blinded Randomized Controlled Trial. Healthcare (Basel). 2022 Oct 5;10(10):1947. doi: 10.3390/healthcare10101947.
PubMed 36292394