Clinical trial NCT01102816: Acupuncture for Pain Management of Hemodialysis Patients
Official title: Acupuncture for Pain Management of Hemodialysis Patients: a Randomized, Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: End-stage Renal Disease
Chronic Kidney Disease
Keywords: hemodialysis
end-stage renal disease
pain
acupuncture
Lead sponsor: Korea Institute of Oriental Medicine
Sponsor class: OTHER_GOV
First posted: 2010-04-13
Enrollment: 1
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain measured on 0-6 scale of symptom 1 subscale score in the Measure Your Medical Outcome Profile2 (MYMOP2) questionnaire.
timeFrame: 6 weeks
Secondary outcomes:
measure: Depressive moods measured by Beck Depression Inventory (BDI)
timeFrame: 6 weeks
measure: Quality of life of patients measured by Kidney Disease Quality of Life Version 1.3 (KDQOL-V 1.3)
timeFrame: 6 weeks
measure: Other patient-perceived changes on health and daily life measured by the MYMOP2
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Korea Institute of Oriental Medicine (Clinical Research Center)
city: Daejeon
country: Korea, Republic of
facility: Korea Institute of Oriental Medicine
Study officials:
affiliation: Korea Institute of Oriental Medicine
name: Kun Hyung Kim, MS
role: PRINCIPAL_INVESTIGATOR
References: