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The Effectiveness and the Safety of Acupuncture for Symptomatic Care of Hemodialysis Patients: A Case-series

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ClinicalTrials.gov Identifier: NCT00883831
Recruitment Status : Completed
First Posted : April 20, 2009
Last Update Posted : January 25, 2010
Information provided by:
Korea Institute of Oriental Medicine

Brief Summary:


Hemodialysis-dependent patients with an end-stage renal disease (ESRD) suffer from a number of distressing symptoms, such as pain, poor mental health, fatigue, sleep disturbance and pruritus. These negatively influence health-related quality of life in ESRD patients, and some of them result in increased mortality and hospitalization. Acupuncture is a widely employed treatment on several chronic disease or condition. Adjunctive use of acupuncture with conventional treatment could be a possible therapeutic option to establish an optimal care for ESRD patients who experiences co-morbid conditions or complications of hemodialysis. Due to its non-pharmacologic feature, the effects of acupuncture without involving altered pharmacokinetics and drug-interactions in hemodialysis patients, might be another strong point compared to other pharmacological interventions. However, little information is available for the effects and the safety of acupuncture for symptomatic care of hemodialysis patients.

Thus, the investigators propose whether acupuncture could be a effective and safe therapeutic modality for a number of patient-reported symptoms in hemodialysis-dependent patients with ESRD.

Condition or disease Intervention/treatment
Hemodialysis End Stage Renal Disease Procedure: Individualized manual acupuncture

Detailed Description:
This trial is a case-series, with a nested-qualitative study at the end of follow-up. Acupuncture treatment will be provided biweekly for 6 weeks, namely total 12 sessions, and follow-up period will be 4 weeks after the end of treatment. Changes of symptoms, quality of life and occured adverse events will be assessed during study procedure. Patients who agreed joining qualitative research will be interviewed about their experiences of acupuncture in detail.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acupuncture for Symptomatic Care of Hemodialysis Patients: a Case-series
Study Start Date : April 2009
Primary Completion Date : December 2009
Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Individualized manual acupuncture Procedure: Individualized manual acupuncture
Acupuncture treatment will be provided according to traditional korean medicine (TKM) theory which focuses on patient's individual symptoms and conditions. 10-12 needles will be inserted into acupuncture point on the body except one arm where arteriovenous fistula is located for hemodialysis access. Needle retention time will be 30 minutes with intermittent manual stimulation to elicit de-qi sensation. Biweekly treatment will be conducted at non-dialysis access day or before hemodialysis at dialysis-access day for 6 weeks.

Primary Outcome Measures :
  1. Measure Your Medical Outcome Profile2 (MYMOP) [ Time Frame: Evaluated at baseline, post-treatment, and 4 weeks after post-treatment (total 3 times) ]

Secondary Outcome Measures :
  1. Kidney Disease Quality of Life-SF V1.3 (KDQOL-SF V 1.3) questionnaire [ Time Frame: Evaluated at baseline, post-treatment, and 4 weeks after post-treatment (total 3 times) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • over 19 years old
  • started hemodialysis at least 3 months ago
  • receiving hemodialysis 3 times a week regularly
  • equilibrated Kt/V ≥ 1.2
  • willingness to participate in this study

Exclusion Criteria:

  • acute/chronic liver disease
  • events of life-threatening cardiovascular disease within 6 months
  • events of life-threatening neurological disorder within 6 months
  • current/past history of neoplasm
  • hemorrhagic disorders
  • drug abuse/alcoholism
  • other infectious disease including active tuberculosis
  • history of the use of acupuncture, moxibustion or herbs within 1 month

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00883831

Korea, Republic of
Doonsan Oriental Hospital of Daejeon University
Daejeon, Korea, Republic of, 302-869
Sponsors and Collaborators
Korea Institute of Oriental Medicine
Principal Investigator: Sun Mi Choi, PhD Korea Institute of Oriental Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Korea Institute of Oriental Medicine
ClinicalTrials.gov Identifier: NCT00883831     History of Changes
Other Study ID Numbers: KI0904
First Posted: April 20, 2009    Key Record Dates
Last Update Posted: January 25, 2010
Last Verified: April 2009

Keywords provided by Korea Institute of Oriental Medicine:
end stage renal disease
chronic kidney disease
supportive care

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency