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

Study Overview
=================
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.

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

Conditions
-----------------
Hemodialysis, End Stage Renal Disease

Intervention / Treatment
-----------------
* Procedure: Individualized manual acupuncture


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Individualized manual acupuncture<br> | Procedure: Individualized manual acupuncture<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acupuncture, Hemodialysis, Symptom, end stage renal disease, chronic kidney disease, supportive care