Intradialytic Fatigue, Chronic Kidney Disease, Acupuncture
Conditions
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.
Detailed description
Fatigue is multidimensional, driven by anemia, chronic inflammation, metabolic acidosis, muscle wasting, sleep disturbances, and depression, and it is associated with increased morbidity and mortality. Intradialytic fatigue, a highly prevalent symptom affecting 60-97% of chronic kidney disease patients undergoing routine hemodialysis. Current management-erythropoiesis-stimulating agents, sodium bicarbonate, L-carnitine, antidepressants, exercise, and cognitive behavioral therapy-is often limited by inconsistent efficacy, side effects, and high cost. Acupuncture is a safe, low-risk non-pharmacological option, but no Indonesian study has tested manual acupuncture for intradialytic fatigue using the Brief Fatigue Inventory (BFI). 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. This is a single-blind, randomized, placebo-controlled crossover clinical trial conducted from October to November 2026 at the Hemodialysis Installation of RSU Kabupaten Tangerang. Participants are chronic kidney disease patients on routine twice-weekly hemodialysis for at least six months who experience intradialytic fatigue. Subjects are randomized by simple randomization into two sequence groups (A: manual then sham; B: sham then manual), with a one-week washout between periods. Blinding is applied to subjects and outcome evaluators, while the acupuncturist performing the intervention is unavoidably aware of group allocation. After eligibility screening and informed consent, participants complete two treatment periods separated by a one-week washout. Each period includes two hemodialysis sessions (days 1 and 4), with acupuncture or sham administered one hour after dialysis begins. BFI assessments are taken at dialysis start (pre-treatment) and one hour after dialysis ends (post-treatment) on each study day. Group A receives manual acupuncture in week 1 and sham in week 3; Group B receives the reverse sequence. Subjects are instructed not to receive any other acupuncture during the study. The primary outcome is the change in fatigue score measured by the Indonesian version of the Brief Fatigue Inventory (BFI), a nine-item instrument using 0-10 numeric scales that assesses fatigue severity (current, usual, worst in 24 hours) and interference with general activity, mood, walking, work, relationships, and enjoyment of life. Secondary outcome is the incidence and percentage of adverse events, including pain, bleeding, hematoma, syncope, infection, or other reported complaints. BFI is assessed by an independent trained evaluator at dialysis start and two hour after dialysis ends on each study day. Data are processed with SPSS version 26. Categorical variables (sex, education) are presented as frequencies and percentages; numeric variables are tested for normality with Shapiro-Wilk and reported as mean ± SD or median (min-max) accordingly. Paired comparisons within subjects use paired t-test or Wilcoxon test, while between-group comparisons use independent t-test or Mann-Whitney test. Statistical significance is set at p \< 0.05. The crossover design allows within-subject comparison, increasing statistical power and reducing inter-individual variability.
Interventions
DEVICEManual Acupuncture
Manual acupuncture is performed using sterile Huanqiu® needles
DEVICESham Acupuncture
Sham acupuncture is performed using with blunt-tipped needles
Sponsors
Universitas Indonesia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The principal investigator will not blinded in this intervention
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brief Fatigue Index (BFI) | baseline (after dialysis is running over 1 hour), 2 hours after dialysis is finished | 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. |
Countries
Indonesia
Contacts
CONTACTDaniel Lie, MD
PRINCIPAL_INVESTIGATORMedical Acupuncture Study Program FKUI
Medical Acupuncture Study Program Faculty of Medicine Universitas Indonesia
Outcome results
None listed