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

End Stage Renal Disease Clinical Trial

Official title:

Acupuncture for Symptomatic Care of Hemodialysis Patients: a Case-series

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00883831
• Other study ID #: KI0904
• Status: Completed
• Phase: N/A
• First received: April 17, 2009
• Last updated: January 22, 2010
• Start date: April 2009
• Est. completion date: January 2010

Study information

• Verified date: April 2009
• 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

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Renal Disease
• Hemodialysis
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Procedure:
• Individualized manual acupuncture
Acupuncture treatment will be provided according to traditional korean medicine (TKM) theory which focuses on patient's individual symptoms and conditions. 10-12 needles will be inserted into acupuncture point on the body except one arm where arteriovenous fistula is located for hemodialysis access. Needle retention time will be 30 minutes with intermittent manual stimulation to elicit de-qi sensation. Biweekly treatment will be conducted at non-dialysis access day or before hemodialysis at dialysis-access day for 6 weeks.

Locations

Country	Name	City	State
Korea, Republic of	Doonsan Oriental Hospital of Daejeon University	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	Measure Your Medical Outcome Profile2 (MYMOP)		Evaluated at baseline, post-treatment, and 4 weeks after post-treatment (total 3 times)	No
Secondary	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)	No