NCT04356794

Heart Rate Variability Assessment in Dialysis Patients by Acupuncture

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: China Medical University, Taiwan · Academic / Other
• Sex: All
• Age: 20 Years – 90 Years
• Healthy volunteers: Accepted

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.

Conditions

• RLS

Interventions

Type	Name	Description
OTHER	Acupuncture needle with electrical stimulation	EA is treated for 4 weeks, 3 times per week.
OTHER	Sham electroacupuncture	Sham EA is treated for 4 weeks, 3 times per week.

Timeline

• Start date: 2019-08-23
• Primary completion: 2020-08-31
• Completion: 2021-12-31
• First posted: 2020-04-22
• Last updated: 2024-02-13

Locations

1 site across 1 country: Taiwan