Acupuncture for Pain Management of Hemodialysis Patients

Study Overview
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Brief Summary
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The purpose of this study is to determine the feasibility, effectiveness and safety of acupuncture for pain management in hemodialysis patients.

Detailed Description
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Pain is one of the most common symptoms experienced by end-stage renal disease (ESRD) patients, which subsequently debilitates patient's quality of life. Although reducing pain is crucial to successful patient care in hemodialysis population, symptoms are often undertreated.Conventional pharmacological approaches are limited in dialysis population , given their altered pharmacokinetics and pharmacodynamic profiles and increased potential for adverse reactions. Acupuncture has been known to be beneficial in various chronic pain condition. As a non-pharmacologic intervention, it might be valuable for pain management in hemodialysis patients whose analgesic use are limited due to altered pharmacokinetics. However, little is known for the benefits of acupuncture for pain management in dialysis population. This study aims to determine whether acupuncture is a feasible, effective and safe therapeutic intervention for pain management in hemodialysis patients.

Official Title
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Acupuncture for Pain Management of Hemodialysis Patients: a Randomized, Controlled Pilot Study

Conditions
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End-stage Renal Disease, Chronic Kidney Disease

Intervention / Treatment
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* Other: Individualized acupuncture treatment
* Other: Routine care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: started hemodialysis at least 3 months ago receiving hemodialysis 3 times a week regularly equilibrated Kt/V ≥ 1.2 pain occurred at least 3 months ago MYMOP2 symptom 1 score ≥ 3 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 (in past 5 years) hemorrhagic disorder drug abuse/alcoholism other infectious disease history of the use of acupuncture, moxibustion or herbs within 1 month

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Individualized acupuncture<br> | Other: Individualized acupuncture treatment<br>* Individualized acupuncture treatment which focuses on each patient's symptoms and conditions will be provided twice a week for 6 weeks on a non-dialysis access day or before hemodialysis at dialysis-access day. 10-20 acupuncture needles will be inserted on the body except the arteriovenous fistula-located arm(s). Electrical stimulation of acupuncture will be conducted on 4 needles and the remained needles will be manipulated manually to elicit de-qi sensation. Needle retention time will be 20 minutes. Routine care provided by dialysis staffs, primary physicians and other healthcare providers will be maintained. Patients who received acupuncture treatment will be interviewed to explore patient's perceptions and experiences of acupuncture for their pain management. (Nested-qualitative study)<br>|
| No Intervention: Routine care<br> | Other: Routine care<br>* Patients in this group will maintain routine care provided by their dialysis staffs, primary physicians or other healthcare providers for symptomatic care and disease management of end-stage renal disease through 6 weeks. After post-treatment evaluation, acupuncture treatment will be provided to patients who want to receive acupuncture treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain measured on 0-6 scale of symptom 1 subscale score in the Measure Your Medical Outcome Profile2 (MYMOP2) questionnaire. | Patients will be asked to measure their pain on 0-6 scales (higher scores reflect worse pain) in the MYMOP2 questionnaire. Other subscales and summed profiles of MYMOP2 questionnaire will be regarded as secondary outcomes. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive moods measured by Beck Depression Inventory (BDI) | Follow-up evaluation will be conducted after 6 weeks from post-treatment measurement. | 6 weeks | 
| Quality of life of patients measured by Kidney Disease Quality of Life Version 1.3 (KDQOL-V 1.3) | Follow-up evaluation will be conducted after 6 weeks from post-treatment measurement. | 6 weeks | 
| Other patient-perceived changes on health and daily life measured by the MYMOP2 | Other changes of patients' health and daily life measured by Symptom 2(if measured), activity, and well-being subscales and total MYMOP2 profiles in the MYMOP2 questionnaire would be regarded as secondary outcomes. Follow-up evaluation will be conducted after 6 weeks from post-treatment measurememt. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemodialysis, end-stage renal disease, pain, acupuncture