Acupuncture for Pain Management of Hemodialysis Patients

NCT ID: NCT01102816

Last Updated: 2011-01-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2011-04-30

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.

Conditions

End-stage Renal Disease; Chronic Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Individualized acupuncture

Group Type: EXPERIMENTAL

Individualized acupuncture treatment

Intervention Type: OTHER

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

Group Type: NO_INTERVENTION

Routine care

Intervention Type: OTHER

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.

Interventions

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)

Intervention Type: 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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Korea Institute of Oriental Medicine

OTHER_GOV

Sponsor Role: lead

Responsible Party

Acupuncture, Moxibustion and Meridian Research Center

Principal Investigators

Kun Hyung Kim, MS

Role: PRINCIPAL_INVESTIGATOR

Korea Institute of Oriental Medicine

Locations

Korea Institute of Oriental Medicine (Clinical Research Center)

Daejeon, , South Korea

Korea Institute of Oriental Medicine

Daejeon, , South Korea

Countries

South Korea

Other Identifiers

KI0908

Identifier Type: OTHER

Identifier Source: secondary_id

KI0908

Identifier Type: -

Identifier Source: org_study_id