The Effectiveness and the Safety of Acupuncture for Symptomatic Care of Hemodialysis Patients: A Case-series

Not Applicable

Completed

• Conditions: Hemodialysis; End Stage Renal Disease
• Interventions: Procedure: Individualized manual acupuncture

• Registration Number: NCT00883831
• Lead Sponsor: Korea Institute of Oriental Medicine

Brief Summary

Purpose:

Hemodialysis-dependent patients with an end-stage renal disease (ESRD) suffer from a number of distressing symptoms, such as pain, poor mental health, fatigue, sleep disturbance and pruritus. These negatively influence health-related quality of life in ESRD patients, and some of them result in increased mortality and hospitalization. Acupuncture is a widely employed treatment on several chronic disease or condition. Adjunctive use of acupuncture with conventional treatment could be a possible therapeutic option to establish an optimal care for ESRD patients who experiences co-morbid conditions or complications of hemodialysis. Due to its non-pharmacologic feature, the effects of acupuncture without involving altered pharmacokinetics and drug-interactions in hemodialysis patients, might be another strong point compared to other pharmacological interventions. However, little information is available for the effects and the safety of acupuncture for symptomatic care of hemodialysis patients.

Thus, the investigators propose whether acupuncture could be a effective and safe therapeutic modality for a number of patient-reported symptoms in hemodialysis-dependent patients with ESRD.

Detailed Description

This trial is a case-series, with a nested-qualitative study at the end of follow-up. Acupuncture treatment will be provided biweekly for 6 weeks, namely total 12 sessions, and follow-up period will be 4 weeks after the end of treatment. Changes of symptoms, quality of life and occured adverse events will be assessed during study procedure. Patients who agreed joining qualitative research will be interviewed about their experiences of acupuncture in detail.

Study Timeline

• Status Verified: 2009-04
• Study Start: 2009-04
• Study First Submitted: 2009-04-17
• Study First Submitted QC: 2009-04-17
• Study First Posted: 2009-04-20
• Primary Completion: 2009-12
• Study Completion: 2010-01
• Last Update Submitted: 2010-01-22
• Last Update Posted: 2010-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• over 19 years old
• started hemodialysis at least 3 months ago
• receiving hemodialysis 3 times a week regularly
• equilibrated Kt/V ≥ 1.2
• 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
• hemorrhagic disorders
• drug abuse/alcoholism
• other infectious disease including active tuberculosis
• history of the use of acupuncture, moxibustion or herbs within 1 month

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Individualized manual acupuncture	Individualized manual acupuncture	-

Primary Outcome Measures

Name	Time	Method
Measure Your Medical Outcome Profile2 (MYMOP)	Evaluated at baseline, post-treatment, and 4 weeks after post-treatment (total 3 times)

Secondary Outcome Measures

Name	Time	Method
Kidney Disease Quality of Life-SF V1.3 (KDQOL-SF V 1.3) questionnaire	Evaluated at baseline, post-treatment, and 4 weeks after post-treatment (total 3 times)

Trial Locations

Locations (1)

Doonsan Oriental Hospital of Daejeon University; 🇰🇷 Daejeon, Korea, Republic of