Manual Acupuncture for Intradialytic Fatigue in CKD Patients

NCT07887386 | Not Yet Recruiting

• 1 other identifier: 0327/EC/KEPK/09/2026_
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the immediate effects of acupuncture therapy at three specific acupuncture points (PC6, ST36, and KI3) on intradialytic fatigue in patients with chronic kidney disease undergoing regular hemodialysis. The outcome will be assessed using the Brief Fatigue Inventory (BFI) before treatment and two hours after completion of hemodialysis.

Conditions

Intradialytic Fatigue; Chronic Kidney Disease; Acupuncture

Outcome Measures

Primary Outcomes (1)

• Brief Fatigue Index (BFI)

  The Brief Fatigue Inventory (BFI) was developed as a concise instrument capable of evaluating both fatigue severity and its impact on daily functioning. The BFI consists of nine items rated on a numerical scale of 0-10. The first three items assess fatigue severity, including current fatigue, usual fatigue experienced during the past 24 hours, and the worst fatigue experienced during the past 24 hours. The remaining six items evaluate the extent to which fatigue interferes with general activity, mood, walking ability, normal work, relationships with others, and enjoyment of life. The total BFI score is calculated as the mean of all nine items. One of the main advantages of the BFI is its short administration time, approximately 2-5 minutes, making it particularly suitable for patients experiencing severe fatigue.

  baseline (after dialysis is running over 1 hour), 2 hours after dialysis is finished

Study Arms (2)

Manual Acupuncture

EXPERIMENTAL

Manual acupuncture is performed at bilateral PC6 (Neiguan), ST36 (Zusanli), and KI3 (Taixi) using sterile Huanqiu® needles (0.25 × 25 mm) inserted 20 mm deep through a hole in a transparent waterproof Onemed® plaster, guided by a 20-mm tube. Needles are retained for 20 minutes without manipulation and then removed, twice per treatment period. Sample are blindfolded during the procedure.

Device: Manual Acupuncture

Sham Acupuncture

SHAM COMPARATOR

Manual acupuncture is performed at bilateral PC6 (Neiguan), ST36 (Zusanli), and KI3 (Taixi) using with blunt-tipped needles that only press against an intact plaster without penetrating the skin above the Onemed® plaster, pressed by a 20-mm tube, controlling for pressure sensation and expectation. Sample are blindfolded during the procedure.

Device: Sham Acupuncture

Interventions

Manual Acupuncture DEVICE

Manual acupuncture is performed using sterile Huanqiu® needles

Manual Acupuncture

Sham Acupuncture DEVICE

Sham acupuncture is performed using with blunt-tipped needles

Sham Acupuncture

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with chronic kidney disease experiencing intradialytic fatigue who are undergoing routine hemodialysis twice weekly for at least 6 months and are hemodynamically stable (blood pressure ≥90/60 mmHg and heart rate of 60-100 beats/minute).
• Participants aged 18-59 years.
• Participants who have not received acupuncture therapy for at least one month prior to the study.
• Participants who are willing to participate in the study according to the scheduled protocol until completion and who provide written informed consent.

You may not qualify if:

• Participants with malignancies or infected wounds at the acupuncture points targeted for intervention.
• Participants with primary skin diseases, such as allergic dermatitis, irritant contact dermatitis, neurodermatitis, and psoriasis.
• Participants with a history of hypersensitivity reactions to previous acupuncture therapy, including stainless steel allergy, atopy, keloid formation, or other hypersensitivity reactions.
• Participants receiving cognitive behavioral therapy (CBT) or psychiatric medications within two weeks prior to the study.

Sponsors & Collaborators

• Universitas Indonesia: lead

Study Sites (1)

Universitas Indonesia

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Medical Acupuncture Study Program FKUI

  Medical Acupuncture Study Program Faculty of Medicine Universitas Indonesia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Lie, MD

CONTACT

+6287782965062; daniel31@ui.ac.id

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The principal investigator will not blinded in this intervention
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: There will be two sequence groups (A: manual then sham; B: sham then manual), with a one-week washout between periods. Manual acupuncture is performed at bilateral PC6 (Neiguan), ST36 (Zusanli), and KI3 (Taixi) using sterile Huanqiu® needles (0.25 × 25 mm) inserted 20 mm deep through a hole in a transparent waterproof Onemed® plaster, guided by a 20-mm tube. Needles are retained for 20 minutes without manipulation and then removed, twice per treatment period. The sham group receives identical preparation but with blunt-tipped needles that only press against an intact plaster without penetrating the skin, controlling for pressure sensation and expectation. Both groups are blindfolded during the procedure.

Study Record Dates

• First Submitted: October 14, 2026
• First Posted: October 21, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 21, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)