Acupuncture for Pain Management of Hemodialysis Patients

January 25, 2011 updated by: Korea Institute of Oriental Medicine

Acupuncture for Pain Management of Hemodialysis Patients: a Randomized, Controlled Pilot Study

The purpose of this study is to determine the feasibility, effectiveness and safety of acupuncture for pain management in hemodialysis patients.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Daejeon, Korea, Republic of, 305-811
        • Korea Institute of Oriental Medicine (Clinical Research Center)
      • Daejeon, Korea, Republic of, 305-811
        • Korea Institute of Oriental Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Routine care
Other: Routine care
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.
Experimental: Individualized acupuncture
Other: Individualized acupuncture treatment

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain measured on 0-6 scale of symptom 1 subscale score in the Measure Your Medical Outcome Profile2 (MYMOP2) questionnaire.
Time Frame: 6 weeks
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.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depressive moods measured by Beck Depression Inventory (BDI)
Time Frame: 6 weeks
Follow-up evaluation will be conducted after 6 weeks from post-treatment measurement.
6 weeks
Quality of life of patients measured by Kidney Disease Quality of Life Version 1.3 (KDQOL-V 1.3)
Time Frame: 6 weeks
Follow-up evaluation will be conducted after 6 weeks from post-treatment measurement.
6 weeks
Other patient-perceived changes on health and daily life measured by the MYMOP2
Time Frame: 6 weeks
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.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea Institute of Oriental Medicine

Investigators

  • Principal Investigator: Kun Hyung Kim, MS, Korea Institute of Oriental Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Anticipated)

February 1, 2011

Study Completion (Anticipated)

April 1, 2011

Study Registration Dates

First Submitted

April 9, 2010

First Submitted That Met QC Criteria

April 12, 2010

First Posted (Estimate)

April 13, 2010

Study Record Updates

Last Update Posted (Estimate)

January 26, 2011

Last Update Submitted That Met QC Criteria

January 25, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KI0908 (Other Identifier: Korea Institute of Oriental Medicine)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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