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Completed

NCT Number: NCT00883831

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

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.

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Key information

Conditions

Hemodialysis Chronic Disease Disease Attributes End Stage Renal Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Doonsan Oriental Hospital of Daejeon University

Daejeon, 302-869, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Individualized manual acupuncture

Procedure

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.

Primary outcomes

  1. Measure Your Medical Outcome Profile2 (MYMOP)

    Time frame: Evaluated at baseline, post-treatment, and 4 weeks after post-treatment (total 3 times)

Secondary outcomes

  1. Kidney Disease Quality of Life-SF V1.3 (KDQOL-SF V 1.3) questionnaire

    Time frame: Evaluated at baseline, post-treatment, and 4 weeks after post-treatment (total 3 times)

Sponsors and collaborators

Lead sponsor

Korea Institute of Oriental Medicine

Other Gov

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Apr 20, 2009
Registry last updated
Jan 25, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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