Acupuncture for Symptom Burden and Quality of Life in Patients With End-Stage Kidney Disease

NCT07887607 | Not Yet Recruiting

• 1 other identifier: ACUP-ESKD
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

End Stage Kidney Disease (ESKD)

Keywords

Acupuncture; Hemodialysis; Peritoneal Dialysis; Health-Related Quality of Life; Symptom Burden; Neuropeptides; Proteomics

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, week 6, week 12, and week 24

Secondary Outcomes (10)

• Change in handgrip strength

  Baseline, week 6, week 12, and week 24

• Change in individual symptom scores assessed by the ESAS-r

  Baseline, week 6, week 12, and week 24

• Change in Pittsburgh Sleep Quality Index (PSQI) global score

  Baseline, week 6, week 12, and week 24

• Change in Brief Pain Inventory (BPI) pain interference score

  Baseline, week 6, week 12, and week 24

• Change in pressure pain threshold assessed by algometry

  Baseline, week 6, week 12, and week 24

Study Arms (2)

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.

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.

Other: Sham Acupuncture

Interventions

Acupuncture OTHER

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.

Acupuncture

Sham Acupuncture OTHER

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.

Sham Acupuncture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University General Hospital of Heraklion: lead

Study Sites (1)

University General Hospital of Heraklion (PAGNI)

Heraklion, 71110, Greece

Location

Related Publications (5)

• 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.

  PMID: 39022010 BACKGROUND

• Fletcher 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.

  PMID: 35385471 BACKGROUND

• Correia 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.

  PMID: 36292497 BACKGROUND

• Liu 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.

  PMID: 38189090 BACKGROUND

• Correia 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.

  PMID: 36292394 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Nephrologist

Study Record Dates

• First Submitted: October 8, 2026
• First Posted: October 21, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: October 21, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)