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

Primary Purpose

Hemodialysis, End Stage Renal Disease

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Individualized manual acupuncture
Sponsored by
Korea Institute of Oriental Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemodialysis focused on measuring Acupuncture, Hemodialysis, Symptom, end stage renal disease, chronic kidney disease, supportive care

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Doonsan Oriental Hospital of Daejeon University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Individualized manual acupuncture

Arm Description

Outcomes

Primary Outcome Measures

Measure Your Medical Outcome Profile2 (MYMOP)

Secondary Outcome Measures

Kidney Disease Quality of Life-SF V1.3 (KDQOL-SF V 1.3) questionnaire

Full Information

First Posted
April 17, 2009
Last Updated
January 22, 2010
Sponsor
Korea Institute of Oriental Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00883831
Brief Title
The Effectiveness and the Safety of Acupuncture for Symptomatic Care of Hemodialysis Patients: A Case-series
Official Title
Acupuncture for Symptomatic Care of Hemodialysis Patients: a Case-series
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Korea Institute of Oriental Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemodialysis, End Stage Renal Disease
Keywords
Acupuncture, Hemodialysis, Symptom, end stage renal disease, chronic kidney disease, supportive care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Individualized manual acupuncture
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Individualized manual acupuncture
Intervention Description
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 Measure Information:
Title
Measure Your Medical Outcome Profile2 (MYMOP)
Time Frame
Evaluated at baseline, post-treatment, and 4 weeks after post-treatment (total 3 times)
Secondary Outcome Measure Information:
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sun Mi Choi, PhD
Organizational Affiliation
Korea Institute of Oriental Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Doonsan Oriental Hospital of Daejeon University
City
Daejeon
ZIP/Postal Code
302-869
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
21721925
Citation
Kim KH, Kim TH, Kang JW, Sul JU, Lee MS, Kim JI, Shin MS, Jung SY, Kim AR, Kang KW, Choi SM. Acupuncture for symptom management in hemodialysis patients: a prospective, observational pilot study. J Altern Complement Med. 2011 Aug;17(8):741-8. doi: 10.1089/acm.2010.0206. Epub 2011 Jul 1.
Results Reference
derived

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

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