Laser Acupuncture for Fatigue in Hemodialysis Patients

NCT07538310 | Not Yet Recruiting

• 1 other identifier: TCHIRB-11405003
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if laser acupuncture (low-level laser therapy) works to treat fatigue and improve quality of life in adults with end-stage renal disease (ESRD) undergoing hemodialysis. It will also learn about how laser acupuncture affects blood circulation and autonomic nervous system balance. The main questions it aims to answer are:

1. 1.Does laser acupuncture reduce the severity of fatigue and its interference with daily life?
2. 2.Can laser acupuncture improve related symptoms such as insomnia, poor appetite, and skin itching?
3. 3.How does laser acupuncture affect objective markers like microcirculation and heart rate variability? Researchers will compare laser acupuncture to a sham treatment (a look-alike procedure using a device that does not emit a laser) to see if laser acupuncture works to treat fatigue.
4. 4.Receive laser acupuncture or a sham treatment during their regular hemodialysis sessions 3 times a week for 4 weeks.
5. 5.Have their fatigue and life quality assessed through questionnaires on the first day, at 4 weeks, and at 8 weeks.
6. 6.Undergo non-invasive tests to measure microcirculation, heart rate variability, and pulse waves, and have photos of their tongue taken for Chinese medicine assessment.

Conditions

ESRD (End Stage Renal Disease); Dialysis; Fatigue

Keywords

Hemodialysis; End-Stage Renal Disease; Laser Acupuncture; Photobiomodulation; Fatigue; Quality of Life; Microcirculation; Low-Level Laser Therapy; Traditional Chinese Medicine; Heart Rate Variability

Outcome Measures

Primary Outcomes (2)

• VAS for fatigue

  The VAS is a subjectively reported scale used to evaluate fatigue intensity. Participants mark their fatigue level on a 100-mm line ranging from "no symptoms" (0) to "most severe symptoms" (100). Higher scores indicate more severe fatigue.

  Baseline (Day 0), Week 4 (end of intervention), and Week 8 (follow-up).

• Brief Fatigue Inventory (BFI)

  The BFI consists of 9 items assessing the severity of fatigue and its impact on daily functional activities over the past week. Each item is scored from 0 to 10, with higher total scores representing more severe fatigue and greater interference with daily life.

  Baseline (Day 0), Week 4 (end of intervention), and Week 8 (follow-up).

Secondary Outcomes (7)

• Kidney Disease Quality of Life 36 (KDQOL-36)

  Baseline, Week 4, and Week 8.

• Laser Doppler Flowmetry Analysis (LDFA) Score

  Baseline, Week 4, and Week 8.

• Photoplethysmography Analysis (PPGA) Score

  Baseline, Week 4, and Week 8.

• Brachial Pulse Wave Analysis (BPWA) score

  Baseline, Week 4, and Week 8.

• Heart Rate Variability (HRV)

  Baseline, Week 4, and Week 8.

Study Arms (2)

Laser Acupuncture Group

EXPERIMENTAL

Active low-level laser therapy at 7 specific acupoints.

Device: Low-Level Laser Acupuncture (LA)

Sham Control Group

SHAM COMPARATOR

Inactive laser treatment using an identical-looking device without energy output.

Device: Sham Laser Acupuncture

Interventions

Low-Level Laser Acupuncture (LA) DEVICE

Device: Low-level laser therapy (LLLT) device. Acupoints: KI1 (Yongquan), ST36 (Zusanli), SP10 (Xuehai), PC8 (Laogong), EX-UE9 (Bafeng), EX-UE9 (Baxie), and LU9 (Taiyuan). Dosage/Frequency: Administered 3 times per week during the hemodialysis process for 4 weeks. Duration: Each treatment session lasts approximately 15 to 30 minutes.

Laser Acupuncture Group

Sham Laser Acupuncture DEVICE

Description:Device: An inactive sham laser device that is identical in appearance and operational procedure to the active device. Procedure: The device will be applied to the same 7 acupoints (KI1, ST36, SP10, PC8, Bafeng, Baxie, LU9) for 15-30 minutes. Blinding: The device will not emit actual laser energy but will mimic the treatment process to maintain participant blinding. Frequency: 3 times per week for 4 weeks during hemodialysis.

Sham Control Group

Eligibility Criteria

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

You may qualify if:

• Patients with End-Stage Renal Disease (ESRD) who require regular maintenance hemodialysis.
• Must undergo hemodialysis treatment at least 3 times per week.
• Aged 18 years or older.
• Willing and able to provide informed consent to participate in the study.

You may not qualify if:

• Presence of acute infectious symptoms.
• Unstable vital signs.
• Diagnosis of malignant tumors.
• Pregnancy.
• Presence of open wounds at the sites designated for laser intervention.
• Patients with implanted cardiac pacemakers or other cardiac devices.

Sponsors & Collaborators

• Taipei City Hospital: lead
• National Yang Ming Chiao Tung University: collaborator
• National Taiwan University of Science and Technology: collaborator

Study Sites (1)

Taipei City Hospital, Renai Branch

Taipei, Taipei, 106, Taiwan

Location

Related Publications (5)

• Saito M, Jingu H, Osawa H, Oyama Y, Tanaka T, Shiono A, Machida M. Pulse Amplitude Measured with a Portable Laser Doppler Flowmeter Is Useful for Screening of Dialysis Patients for Peripheral Arterial Disease: An Observational Study. Ann Vasc Dis. 2022 Dec 25;15(4):301-307. doi: 10.3400/avd.oa.21-00126.

  PMID: 36644273 BACKGROUND

• Yang J, Mallory MJ, Wu Q, Bublitz SE, Do A, Xiong D, Chen CYY, Dorsher PT, Chon TY, Bauer BA. The Safety of Laser Acupuncture: A Systematic Review. Med Acupunct. 2020 Aug 1;32(4):209-217. doi: 10.1089/acu.2020.1419. Epub 2020 Aug 13.

  PMID: 32874405 BACKGROUND

• Natale P, Ju A, Strippoli GF, Craig JC, Saglimbene VM, Unruh ML, Stallone G, Jaure A. Interventions for fatigue in people with kidney failure requiring dialysis. Cochrane Database Syst Rev. 2023 Aug 31;8(8):CD013074. doi: 10.1002/14651858.CD013074.pub2.

  PMID: 37651553 BACKGROUND

• Bian J, Liebert A, Bicknell B, Chen XM, Huang C, Pollock CA. Therapeutic Potential of Photobiomodulation for Chronic Kidney Disease. Int J Mol Sci. 2022 Jul 21;23(14):8043. doi: 10.3390/ijms23148043.

  PMID: 35887386 BACKGROUND

• Chang YP, Lin CC, Wu JH, Hsieh YH, Chou KH, Su CT. The impact of photobiomodulation on sleep and life quality in hemodialysis patients: A randomized controlled trial. Lasers Med Sci. 2024 Jul 3;39(1):169. doi: 10.1007/s10103-024-04114-y.

  PMID: 38958682 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Fatigue; Kidney Failure, 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; Signs and Symptoms

Central Study Contacts

Ming Jen Wang, MD

CONTACT

+886-930-766-631; wanters0800@gmail.com

Chao-Tsung Chen, Ph.D.

CONTACT

+886-979-306-080; dai44@tpech.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: This is a randomized, double-blind, sham-controlled, parallel-group pilot trial. Eligible participants with End-Stage Renal Disease (ESRD) undergoing regular hemodialysis will be randomly assigned to either the Laser Acupuncture (LA) group or the Sham Control group in a 1:1 ratio. Each group will follow their assigned intervention protocol simultaneously for a duration of 4 weeks, with clinical outcomes and physiological markers assessed at baseline, 4 weeks, and 8 weeks to evaluate both immediate and follow-up effects.

Study Record Dates

• First Submitted: April 5, 2026
• First Posted: April 20, 2026
• Study Start: April 8, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): August 31, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available beginning 6 months and ending 36 months following article publication.
• Access Criteria: Data requests should be directed to the Principal Investigator. Proposers will need to sign a data access agreement and provide a scientifically sound research proposal.

Locations

TW (1)