Acupuncture for Pain Management of Hemodialysis Patients
- Conditions
- End-stage Renal DiseaseChronic Kidney Disease
- Interventions
- Other: Individualized acupuncture treatmentOther: Routine care
- Registration Number
- NCT01102816
- Lead Sponsor
- Korea Institute of Oriental Medicine
- Brief Summary
The purpose of this study is to determine the feasibility, effectiveness and safety of acupuncture for pain management in hemodialysis patients.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Individualized acupuncture Individualized acupuncture treatment - Routine care Routine care -
- Primary Outcome Measures
Name Time Method Pain measured on 0-6 scale of symptom 1 subscale score in the Measure Your Medical Outcome Profile2 (MYMOP2) questionnaire. 6 weeks 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.
- Secondary Outcome Measures
Name Time Method Depressive moods measured by Beck Depression Inventory (BDI) 6 weeks Follow-up evaluation will be conducted after 6 weeks from post-treatment measurement.
Quality of life of patients measured by Kidney Disease Quality of Life Version 1.3 (KDQOL-V 1.3) 6 weeks Follow-up evaluation will be conducted after 6 weeks from post-treatment measurement.
Other patient-perceived changes on health and daily life measured by the MYMOP2 6 weeks 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.
Trial Locations
- Locations (2)
Korea Institute of Oriental Medicine (Clinical Research Center)
🇰🇷Daejeon, Korea, Republic of
Korea Institute of Oriental Medicine
🇰🇷Daejeon, Korea, Republic of