Heart Rate Variability Assessment in Dialysis Patients by Acupuncture

RLS Clinical Trial

Official title:

Heart Rate Variability Assessment in Dialysis Patients by Acupuncture

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04356794
• Other study ID #: Y_105_0300
• Status: Completed
• Phase: N/A
• Start date: August 23, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2024
• Source: China Medical University, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 31, 2021
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• RLS

Intervention

Other:
• Acupuncture needle with electrical stimulation
EA is treated for 4 weeks, 3 times per week.
• Sham electroacupuncture
Sham EA is treated for 4 weeks, 3 times per week.

Locations

Country	Name	City	State
Taiwan	Changhua Christian Hospital	Changhua

Sponsors (2)

Lead Sponsor	Collaborator
China Medical University, Taiwan	Changhua Christian Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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