Heart Rate Variability Assessment in Dialysis Patients by Acupuncture

Not Applicable

Completed

• Conditions: RLS
• Interventions: Other: Acupuncture needle with electrical stimulation; Other: Sham electroacupuncture

• Registration Number: NCT04356794
• Lead Sponsor: China Medical University, Taiwan

Brief Summary

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

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 Timeline

• Study Start: 2019-08-23
• Study First Submitted: 2020-04-10
• Study First Submitted QC: 2020-04-18
• Study First Posted: 2020-04-22
• Primary Completion: 2020-08-31
• Study Completion: 2021-12-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-09
• Last Update Posted: 2024-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medical electroacupuncture(EA)	Acupuncture needle with electrical stimulation	EA were treated for 4 weeks, 3 times per week.
Sham electroacupuncture	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.

Primary Outcome Measures

Name	Time	Method
Change from Baseline International restless legs syndrome rating scale(IRLSRS) at 4 weeks,5weeks	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 Outcome Measures

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

Trial Locations

Locations (1)

Changhua Christian Hospital; 🇨🇳 Changhua, Taiwan