Acupuncture for Pain Management of Hemodialysis Patients

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01102816
• Other study ID #: KI0908
• Secondary ID: KI0908
• Status: Terminated
• Phase: N/A
• First received: April 9, 2010
• Last updated: January 25, 2011
• Start date: May 2010
• Est. completion date: April 2011

Study information

• Verified date: January 2011
• Source: Korea Institute of Oriental Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: April 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• End-stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

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)
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Korea Institute of Oriental Medicine	Daejeon
Korea, Republic of	Korea Institute of Oriental Medicine (Clinical Research Center)	Daejeon

Sponsors (1)

Lead Sponsor	Collaborator
Korea Institute of Oriental Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 weeks	No
Secondary	Depressive moods measured by Beck Depression Inventory (BDI)	Follow-up evaluation will be conducted after 6 weeks from post-treatment measurement.	6 weeks	No
Secondary	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.	6 weeks	No
Secondary	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.	6 weeks	No