Clinical trial NCT00883831: The Effectiveness and the Safety of Acupuncture for Symptomatic Care of Hemodialysis Patients: A Case-series
Official title: Acupuncture for Symptomatic Care of Hemodialysis Patients: a Case-series
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis
End Stage Renal Disease
Keywords: Acupuncture
Hemodialysis
Symptom
end stage renal disease
chronic kidney disease
supportive care
Lead sponsor: Korea Institute of Oriental Medicine
Sponsor class: OTHER_GOV
First posted: 2009-04-20
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Measure Your Medical Outcome Profile2 (MYMOP)
timeFrame: Evaluated at baseline, post-treatment, and 4 weeks after post-treatment (total 3 times)
Secondary outcomes:
measure: Kidney Disease Quality of Life-SF V1.3 (KDQOL-SF V 1.3) questionnaire
timeFrame: Evaluated at baseline, post-treatment, and 4 weeks after post-treatment (total 3 times)
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Doonsan Oriental Hospital of Daejeon University
Study officials:
affiliation: Korea Institute of Oriental Medicine
name: Sun Mi Choi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim KH, Kim TH, Kang JW, Sul JU, Lee MS, Kim JI, Shin MS, Jung SY, Kim AR, Kang KW, Choi SM. Acupuncture for symptom management in hemodialysis patients: a prospective, observational pilot study. J Altern Complement Med. 2011 Aug;17(8):741-8. doi: 10.1089/acm.2010.0206. Epub 2011 Jul 1.