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Acupuncture for Pain Management of Hemodialysis Patients

Primary Purpose

End-stage Renal Disease, Chronic Kidney Disease

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

About this trial

This is an interventional supportive care trial for End-stage Renal Disease focused on measuring hemodialysis, end-stage renal disease, pain, acupuncture

Eligibility Criteria

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

Inclusion Criteria:

  • started hemodialysis at least 3 months ago
  • receiving hemodialysis 3 times a week regularly
  • equilibrated Kt/V ≥ 1.2
  • pain occurred at least 3 months ago
  • MYMOP2 symptom 1 score ≥ 3
  • 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 (in past 5 years)
  • hemorrhagic disorder
  • drug abuse/alcoholism
  • other infectious disease
  • history of the use of acupuncture, moxibustion or herbs within 1 month

Sites / Locations

  • Korea Institute of Oriental Medicine (Clinical Research Center)
  • Korea Institute of Oriental Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Individualized acupuncture

Routine care

Arm Description

Outcomes

Primary Outcome Measures

Pain measured on 0-6 scale of symptom 1 subscale score in the Measure Your Medical Outcome Profile2 (MYMOP2) questionnaire.
Patients will be asked to measure their pain on 0-6 scales (higher scores reflect worse pain) in the MYMOP2 questionnaire. Other subscales and summed profiles of MYMOP2 questionnaire will be regarded as secondary outcomes.

Secondary Outcome Measures

Depressive moods measured by Beck Depression Inventory (BDI)
Follow-up evaluation will be conducted after 6 weeks from post-treatment measurement.
Quality of life of patients measured by Kidney Disease Quality of Life Version 1.3 (KDQOL-V 1.3)
Follow-up evaluation will be conducted after 6 weeks from post-treatment measurement.
Other patient-perceived changes on health and daily life measured by the MYMOP2
Other changes of patients' health and daily life measured by Symptom 2(if measured), activity, and well-being subscales and total MYMOP2 profiles in the MYMOP2 questionnaire would be regarded as secondary outcomes. Follow-up evaluation will be conducted after 6 weeks from post-treatment measurememt.

Full Information

First Posted
April 9, 2010
Last Updated
January 25, 2011
Sponsor
Korea Institute of Oriental Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01102816
Brief Title
Acupuncture for Pain Management of Hemodialysis Patients
Official Title
Acupuncture for Pain Management of Hemodialysis Patients: a Randomized, Controlled Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Terminated
Why Stopped
We failed to recruit enough patients by regular recruitment methods (i.e., newspaper ads, hospital postings, radios and television ads).
Study Start Date
May 2010 (undefined)
Primary Completion Date
February 2011 (Anticipated)
Study Completion Date
April 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Korea Institute of Oriental Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine the feasibility, effectiveness and safety of acupuncture for pain management in hemodialysis patients.
Detailed Description
Pain is one of the most common symptoms experienced by end-stage renal disease (ESRD) patients, which subsequently debilitates patient's quality of life. Although reducing pain is crucial to successful patient care in hemodialysis population, symptoms are often undertreated.Conventional pharmacological approaches are limited in dialysis population , given their altered pharmacokinetics and pharmacodynamic profiles and increased potential for adverse reactions. Acupuncture has been known to be beneficial in various chronic pain condition. As a non-pharmacologic intervention, it might be valuable for pain management in hemodialysis patients whose analgesic use are limited due to altered pharmacokinetics. However, little is known for the benefits of acupuncture for pain management in dialysis population. This study aims to determine whether acupuncture is a feasible, effective and safe therapeutic intervention for pain management in hemodialysis patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-stage Renal Disease, Chronic Kidney Disease
Keywords
hemodialysis, end-stage renal disease, pain, acupuncture

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Individualized acupuncture
Arm Type
Experimental
Arm Title
Routine care
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Individualized acupuncture treatment
Intervention Description
Individualized acupuncture treatment which focuses on each patient's symptoms and conditions will be provided twice a week for 6 weeks on a non-dialysis access day or before hemodialysis at dialysis-access day. 10-20 acupuncture needles will be inserted on the body except the arteriovenous fistula-located arm(s). Electrical stimulation of acupuncture will be conducted on 4 needles and the remained needles will be manipulated manually to elicit de-qi sensation. Needle retention time will be 20 minutes. Routine care provided by dialysis staffs, primary physicians and other healthcare providers will be maintained. Patients who received acupuncture treatment will be interviewed to explore patient's perceptions and experiences of acupuncture for their pain management. (Nested-qualitative study)
Intervention Type
Other
Intervention Name(s)
Routine care
Intervention Description
Patients in this group will maintain routine care provided by their dialysis staffs, primary physicians or other healthcare providers for symptomatic care and disease management of end-stage renal disease through 6 weeks. After post-treatment evaluation, acupuncture treatment will be provided to patients who want to receive acupuncture treatment.
Primary Outcome Measure Information:
Title
Pain measured on 0-6 scale of symptom 1 subscale score in the Measure Your Medical Outcome Profile2 (MYMOP2) questionnaire.
Description
Patients will be asked to measure their pain on 0-6 scales (higher scores reflect worse pain) in the MYMOP2 questionnaire. Other subscales and summed profiles of MYMOP2 questionnaire will be regarded as secondary outcomes.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Depressive moods measured by Beck Depression Inventory (BDI)
Description
Follow-up evaluation will be conducted after 6 weeks from post-treatment measurement.
Time Frame
6 weeks
Title
Quality of life of patients measured by Kidney Disease Quality of Life Version 1.3 (KDQOL-V 1.3)
Description
Follow-up evaluation will be conducted after 6 weeks from post-treatment measurement.
Time Frame
6 weeks
Title
Other patient-perceived changes on health and daily life measured by the MYMOP2
Description
Other changes of patients' health and daily life measured by Symptom 2(if measured), activity, and well-being subscales and total MYMOP2 profiles in the MYMOP2 questionnaire would be regarded as secondary outcomes. Follow-up evaluation will be conducted after 6 weeks from post-treatment measurememt.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: started hemodialysis at least 3 months ago receiving hemodialysis 3 times a week regularly equilibrated Kt/V ≥ 1.2 pain occurred at least 3 months ago MYMOP2 symptom 1 score ≥ 3 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 (in past 5 years) hemorrhagic disorder drug abuse/alcoholism other infectious disease history of the use of acupuncture, moxibustion or herbs within 1 month
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kun Hyung Kim, MS
Organizational Affiliation
Korea Institute of Oriental Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korea Institute of Oriental Medicine (Clinical Research Center)
City
Daejeon
ZIP/Postal Code
305-811
Country
Korea, Republic of
Facility Name
Korea Institute of Oriental Medicine
City
Daejeon
ZIP/Postal Code
305-811
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Acupuncture for Pain Management of Hemodialysis Patients

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