Heart Rate Variability Assessment in Dialysis Patients by Acupuncture
Study Details
Study Description
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=56 ; Control group using placebo needles, N=56
Outcome measures: International RLS Rating Scale, HRV
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 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.
Study Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Change from Baseline International restless legs syndrome rating scale(IRLSRS) at 4 weeks [Baseline, 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.
Secondary Outcome Measures
- Change from Baseline HRV(LF,HF, RMSSD, PNN50) at 4 weeks [Baseline, 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.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Changhua Christian Hospital | Changhua | Taiwan | 135 |
Sponsors and Collaborators
- China Medical University, Taiwan
- Changhua Christian Hospital
Investigators
- Study Director: Lun-Chien Lo, PHD, China Medical University, Taiwan
Study Documents (Full-Text)
More Information
Publications
- Barone DA, Ebben MR, DeGrazia M, Mortara D, Krieger AC. Heart rate variability in restless legs syndrome and periodic limb movements of Sleep. Sleep Sci. 2017 Apr-Jun;10(2):80-86. doi: 10.5935/1984-0063.20170015.
- Cikrikcioglu MA, Hursitoglu M, Erkal H, Kınas BE, Sztajzel J, Cakirca M, Arslan AG, Erek A, Halac G, Tukek T. Oxidative stress and autonomic nervous system functions in restless legs syndrome. Eur J Clin Invest. 2011 Jul;41(7):734-42. doi: 10.1111/j.1365-2362.2010.02461.x. Epub 2011 Jan 20.
- Cripps MG. Acupuncture for restless legs syndrome in patients previously treated with dopaminergic drugs. Acupunct Med. 2011 Sep;29(3):240-1. doi: 10.1136/acupmed-2011-010039. Epub 2011 Jun 22.
- Pan W, Wang M, Li M, Wang Q, Kwak S, Jiang W, Yamamoto Y. Actigraph evaluation of acupuncture for treating restless legs syndrome. Evid Based Complement Alternat Med. 2015;2015:343201. doi: 10.1155/2015/343201. Epub 2015 Feb 11.
- Raissi GR, Forogh B, Ahadi T, Ghahramanpoori S, Ghaboussi P, Sajadi S. Evaluation of Acupuncture in the Treatment of Restless Legs Syndrome: A Randomized Controlled Trial. J Acupunct Meridian Stud. 2017 Oct;10(5):346-350. doi: 10.1016/j.jams.2017.08.004. Epub 2017 Aug 22. Erratum in: J Acupunct Meridian Stud. 2018 Dec;11(6):380.
- Yıldız A, Yıldız C, Karakurt A. Assessment of cardiac autonomic functions by heart rate variability in patients with restless leg syndrome. Turk Kardiyol Dern Ars. 2018 Apr;46(3):191-196. doi: 10.5543/tkda.2018.33896.
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