Heart Rate Variability Assessment in Dialysis Patients by Acupuncture

February 9, 2024 updated by: Jia-Ming Chen, China Medical University, Taiwan

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Changhua, Taiwan, 135
        • Changhua Christian Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Medical electroacupuncture(EA)
EA were treated for 4 weeks, 3 times per week.
Other: Acupuncture needle with electrical stimulation
EA is treated for 4 weeks, 3 times per week.
Sham Comparator: Sham electroacupuncture
Sham acupuncture was performed without stimulation and manipulation to avoid eliciting "De Qi" sensations.It were treated for 4 weeks, 3 times per week.
Other: Sham electroacupuncture
Sham EA is treated for 4 weeks, 3 times per week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 4 weeks, 5weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 4 weeks, 5weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University, Taiwan

Collaborators

Changhua Christian Hospital

Investigators

  • Study Director: Lun-Chien Lo, PHD, China Medical University, Taiwan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2019

Primary Completion (Actual)

August 31, 2020

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

April 10, 2020

First Submitted That Met QC Criteria

April 18, 2020

First Posted (Actual)

April 22, 2020

Study Record Updates

Last Update Posted (Actual)

February 13, 2024

Last Update Submitted That Met QC Criteria

February 9, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • Y_105_0300

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on RLS

Clinical Trials on Acupuncture needle with electrical stimulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Costa Rica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe