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Completed

NCT Number: NCT04356794

Heart Rate Variability Assessment in Dialysis Patients by Acupuncture

Title of the study:Heart Rate Variability Assessment in Dialysis Patients by Acupuncture

Study period: 08/2019 - 07/2021

Institution: the Graduate Institute of Chinese Medical Science, China Medical University/ Changhua Christian Hospital,Taiwan

Aim of the study: To investigate the effect of medical acupuncture in comparison to placebo acupuncture by heart rate variability(HRV)

Design: Prospective randomized trial

Intervention: Experiment group using indwelling fixed needles, N=30 ; Control group using placebo needles, N=30

Outcome measures: International RLS Rating Scale, HRV

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Key information

Conditions

RLS

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Changhua Christian Hospital

Changhua, 135, Taiwan

About this study

RLS occurs in 3-15% of the general population and in 10-30% of patients on maintenance dialysis. End-stage renal disease, a decrease in HRV is typically found, with abnormal HRV being considered an independent risk factor for mortality.While the majority of studies show an initial improvement in symptoms, longer studies and clinical experience show that either treatment efficacy decreases with time, and/or augmentation develops: dopaminergic augmentation has been reported to be the main reason for treatment discontinuation and treatment failure in RLS/WED.

The study randomly assigned to either true acupuncture treatment or placebo/sham acupuncture treatment. Each participant will undergo 12 treatments third-weekly, for a period of 4 weeks. At the end of the eighth treatment session, each participant will again fill out a IRLSRS questionnaire ,ISI and HRV test. At the end of the treatment regimen and 5weeks, participants will again fill out a IRLSRS questionnaire ,ISI and HRV test.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Dialysis patients with RLS
  • The symptoms expressed ≧ 3 months and more than twice per week.
  • A score of at least 20 corresponding to severe RLS ( International Restless Legs Syndrome Rating Scale, IRLSRS).Dialysis patients with RLS

Exclusion criteria

  • Idiopathic RLS
  • Other movement disorders, various psychiatric and organic disorders, cognitive impairment, or bleeding disorders, on anticoagulant therapy, or cardiac pacemaker.

Treatment and study plan

Acupuncture needle with electrical stimulation

Other

EA is treated for 4 weeks, 3 times per week.

Sham electroacupuncture

Other

Sham EA is treated for 4 weeks, 3 times per week.

Primary outcomes

  1. Change from Baseline International restless legs syndrome rating scale(IRLSRS) at 4 weeks,5weeks

    Time frame: Baseline, 4 weeks, 5weeks

    IRLSRS are scored from 4 for the first (top) answer (usually 'very severe') to 0 for the last answer (usually none). All items are scored. The sum of the item scores serves as the scale score.

Secondary outcomes

  1. Change from Baseline ISI and HRV(LF,HF, RMSSD, PNN50) at 4 weeks, 5weeks

    Time frame: Baseline, 4 weeks, 5weeks

    HRV is the measure of the inconsistent gaps between each heartbeat and is used as an index for different aspects of psychology. HRV is an index of the influence of both the parasympathetic nervous system and the sympathetic nervous systems.

Sponsors and collaborators

Lead sponsor

China Medical University, Taiwan

Other

Collaborators

  • Changhua Christian Hospital

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Apr 22, 2020
Registry last updated
Feb 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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