Heart Rate Variability Assessment in Dialysis Patients by Acupuncture

NCT04356794 | Completed DMC

• 1 other identifier: Y_105_0300
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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=30 ; Control group using placebo needles, N=30 Outcome measures: International RLS Rating Scale, HRV

Conditions

RLS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change from Baseline ISI and HRV(LF,HF, RMSSD, PNN50) at 4 weeks, 5weeks

  Baseline, 4 weeks, 5weeks

Study Arms (2)

Medical electroacupuncture(EA)

EXPERIMENTAL

EA were treated for 4 weeks, 3 times per week.

Other: Acupuncture needle with electrical stimulation

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.

Other: Sham electroacupuncture

Interventions

Acupuncture needle with electrical stimulation OTHER

EA is treated for 4 weeks, 3 times per week.

Medical electroacupuncture(EA)

Sham electroacupuncture OTHER

Sham EA is treated for 4 weeks, 3 times per week.

Sham electroacupuncture

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Idiopathic RLS
• Other movement disorders, various psychiatric and organic disorders, cognitive impairment, or bleeding disorders, on anticoagulant therapy, or cardiac pacemaker.

Sponsors & Collaborators

• China Medical University, Taiwan: lead
• Changhua Christian Hospital: collaborator

Study Sites (1)

Changhua Christian Hospital

Changhua, 135, Taiwan

Location

Related Publications (7)

• 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.

  PMID: 25763089 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.

  PMID: 21697212 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.

  PMID: 29664425 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.

  PMID: 29078970 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.

  PMID: 28966745 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.

  PMID: 21250984 BACKGROUND

• 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.

  PMID: 33327340 DERIVED

MeSH Terms

Interventions

Electric Stimulation

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques

Study Officials

• Lun-Chien Lo, PHD

  China Medical University, Taiwan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 10, 2020
• First Posted: April 22, 2020
• Study Start: August 23, 2019
• Primary Completion: August 31, 2020
• Study Completion: December 31, 2021
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)