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

This study has been completed.
Sponsor:
Information provided by:
Korea Institute of Oriental Medicine
ClinicalTrials.gov Identifier:
NCT00883831
First received: April 17, 2009
Last updated: January 22, 2010
Last verified: April 2009
History of Changes
  Purpose

Purpose:

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 Intervention
Hemodialysis
End Stage Renal Disease
 Procedure: Individualized manual acupuncture

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Acupuncture for Symptomatic Care of Hemodialysis Patients: a Case-series

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Korea Institute of Oriental Medicine:

Primary Outcome Measures:
  • Measure Your Medical Outcome Profile2 (MYMOP) [ Time Frame: Evaluated at baseline, post-treatment, and 4 weeks after post-treatment (total 3 times) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: April 2009
Study Completion Date: January 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00883831

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

No publications provided by Korea Institute of Oriental Medicine

Additional 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
Study First Received: April 17, 2009
Last Updated: January 22, 2010
Health Authority: South Korea: Institutional Review Board

Keywords provided by Korea Institute of Oriental Medicine:
Acupuncture
Hemodialysis
Symptom
 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

ClinicalTrials.gov processed this record on May 23, 2013