Acupuncture for Pain Management of Hemodialysis Patients
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|ClinicalTrials.gov Identifier: NCT01102816|
Recruitment Status : Terminated (We failed to recruit enough patients by regular recruitment methods (i.e., newspaper ads, hospital postings, radios and television ads).)
First Posted : April 13, 2010
Last Update Posted : January 26, 2011
|Condition or disease||Intervention/treatment||Phase|
|End-stage Renal Disease Chronic Kidney Disease||Other: Individualized acupuncture treatment Other: Routine care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Acupuncture for Pain Management of Hemodialysis Patients: a Randomized, Controlled Pilot Study|
|Study Start Date :||May 2010|
|Estimated Primary Completion Date :||February 2011|
|Estimated Study Completion Date :||April 2011|
|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.
- 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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01102816
|Korea, Republic of|
|Korea Institute of Oriental Medicine (Clinical Research Center)|
|Daejeon, Korea, Republic of, 305-811|
|Korea Institute of Oriental Medicine|
|Daejeon, Korea, Republic of, 305-811|
|Principal Investigator:||Kun Hyung Kim, MS||Korea Institute of Oriental Medicine|