Heart Rate Variability Assessment in Dialysis Patients by Acupuncture

China Medical University, Taiwan35 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

RLS

Interventions

Acupuncture needle with electrical stimulationOTHER

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

Sham electroacupunctureOTHER

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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Changhua Christian Hospital

Changhua, Taiwan

Outcomes

Primary Outcomes

Change from Baseline International restless legs syndrome rating scale(IRLSRS) at 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.

Time frame: Baseline, 4 weeks, 5weeks

Secondary Outcomes

Change from Baseline ISI and HRV(LF,HF, RMSSD, PNN50) at 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.

Time frame: Baseline, 4 weeks, 5weeks

Data from ClinicalTrials.gov

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