Heart Rate Variability Assessment in Dialysis Patients by Acupuncture

Study Overview
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Brief Summary
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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=56 ; Control group using placebo needles, N=56 Outcome measures: International RLS Rating Scale, HRV

Detailed Description
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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 8 treatments twice-weekly, for a period of 4 weeks. At the end of the eighth treatment session, each participant will again fill out a IRLSRS questionnaire and HRV test.Then following a 4-week washout period, patients will be crossed over to either placebo/sham or true acupuncture treatment, again 8 twice-weekly treatments, for a period of 4 weeks. At the end of the second treatment regimen all participants will again fill out a IRLSRS questionnaire and HRV test.

Official Title
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Heart Rate Variability Assessment in Dialysis Patients by Acupuncture

Conditions
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RLS

Intervention / Treatment
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* Other: Acupuncture needle with electrical stimulation
* Other: Sham electroacupuncture


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medical electroacupuncture(EA)<br>EA were treated for 4 weeks, 3 times per week. | Other: Acupuncture needle with electrical stimulation<br>* EA is treated for 4 weeks, 3 times per week.<br>|
| Sham Comparator: Sham electroacupuncture<br>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<br>* Sham EA is treated for 4 weeks, 3 times per week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline International restless legs syndrome rating scale(IRLSRS) at 4 weeks | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline HRV(LF,HF, RMSSD, PNN50) at 4 weeks | 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 |