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Acupuncture for Pain Management of Hemodialysis Patients

This study has been terminated.
(We failed to recruit enough patients by regular recruitment methods (i.e., newspaper ads, hospital postings, radios and television ads).)
Sponsor:
Information provided by:
Korea Institute of Oriental Medicine
ClinicalTrials.gov Identifier:
NCT01102816
First received: April 9, 2010
Last updated: January 25, 2011
Last verified: January 2011
History of Changes
  Purpose

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


Condition Intervention
End-stage Renal Disease
Chronic Kidney Disease
 Other: Individualized acupuncture treatment
Other: Routine care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Acupuncture for Pain Management of Hemodialysis Patients: a Randomized, Controlled Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Pain measured on 0-6 scale of symptom 1 subscale score in the Measure Your Medical Outcome Profile2 (MYMOP2) questionnaire. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 1
Study Start Date: May 2010
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
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.

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01102816

Locations
Korea, Republic of
Korea Institute of Oriental Medicine
Daejeon, Korea, Republic of, 305-811
Korea Institute of Oriental Medicine (Clinical Research Center)
Daejeon, Korea, Republic of, 305-811
Sponsors and Collaborators
Korea Institute of Oriental Medicine
Investigators
Principal Investigator: Kun Hyung Kim, MS Korea Institute of Oriental Medicine
  More Information

No publications provided

Responsible Party: Korea Institute of Oriental Medicine, Acupuncture, Moxibustion and Meridian Research Center
ClinicalTrials.gov Identifier: NCT01102816     History of Changes
Other Study ID Numbers: KI0908, KI0908
Study First Received: April 9, 2010
Last Updated: January 25, 2011
Health Authority: South Korea: Institutional Review Board

Keywords provided by Korea Institute of Oriental Medicine:
hemodialysis
end-stage renal disease
pain
acupuncture

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

ClinicalTrials.gov processed this record on May 23, 2013