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| Name | Class |
|---|---|
| Changhua Christian Hospital | OTHER |
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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=30 ; Control group using placebo needles, N=30
Outcome measures: International RLS Rating Scale, HRV
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medical electroacupuncture(EA) | Experimental | EA were treated for 4 weeks, 3 times per week. |
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| Sham electroacupuncture | Sham Comparator | Sham acupuncture was performed without stimulation and manipulation to avoid eliciting "De Qi" sensations.It were treated for 4 weeks, 3 times per week. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture needle with electrical stimulation | Other | EA is treated for 4 weeks, 3 times per week. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline International restless legs syndrome rating scale(IRLSRS) at 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline ISI and HRV(LF,HF, RMSSD, PNN50) at 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lun-Chien Lo, PHD | China Medical University, Taiwan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhua Christian Hospital | Changhua | 135 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25763089 | Background | 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. | |
| 21697212 | Background | 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. No abstract available. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 23, 2019 | Oct 28, 2020 | Prot_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 23, 2019 | Apr 18, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D004558 | Electric Stimulation |
| ID | Term |
|---|---|
| D010812 | Physical Stimulation |
| D008919 | Investigative Techniques |
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| Sham electroacupuncture | Other | Sham EA is treated for 4 weeks, 3 times per week. |
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| 29664425 | Background | Yildiz A, Yildiz 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. |
| 29078970 | Background | 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. |
| 28966745 | Background | 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. |
| 21250984 | Background | Cikrikcioglu MA, Hursitoglu M, Erkal H, Kinas 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. |
| 33327340 | Derived | Chen JM, Chiu PF, Chang YJ, Hsu PC, Chang CC, Lo LC. Effect of electroacupuncture on restless legs syndrome (RLS) in hemodialysis patients: A protocol for systematic review and meta-analysis. Medicine (Baltimore). 2020 Dec 11;99(50):e23629. doi: 10.1097/MD.0000000000023629. |