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

Tracking Information

First Received Date ^ICMJE

April 9, 2010

Last Updated Date

January 25, 2011

Start Date ^ICMJE

May 2010

Estimated Primary Completion Date

February 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01102816 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Acupuncture for Pain Management of Hemodialysis Patients

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care

Condition ^ICMJE

End-stage Renal Disease
Chronic Kidney Disease

Intervention ^ICMJE

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)
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.

Study Arm (s)

Experimental: Individualized acupuncture
Intervention: Other: Individualized acupuncture treatment
No Intervention: Routine care
Intervention: Other: Routine care

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Estimated Completion Date

April 2011

Estimated Primary Completion Date

February 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

19 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT01102816

Other Study ID Numbers ^ICMJE

KI0908, KI0908

Has Data Monitoring Committee

Yes

Responsible Party

Korea Institute of Oriental Medicine, Acupuncture, Moxibustion and Meridian Research Center

Study Sponsor ^ICMJE

Korea Institute of Oriental Medicine

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Kun Hyung Kim, MS

Korea Institute of Oriental Medicine

Information Provided By

Korea Institute of Oriental Medicine

Verification Date

January 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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