Acupuncture for Pain Management of Hemodialysis Patients

NCT01102816 | Terminated DMC

• 1 other identifier: KI0908
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

End-stage Renal Disease; Chronic Kidney Disease

Keywords

hemodialysis; end-stage renal disease; pain; acupuncture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Depressive moods measured by Beck Depression Inventory (BDI)

  6 weeks

• Quality of life of patients measured by Kidney Disease Quality of Life Version 1.3 (KDQOL-V 1.3)

  6 weeks

• Other patient-perceived changes on health and daily life measured by the MYMOP2

  6 weeks

Study Arms (2)

Individualized acupuncture

EXPERIMENTAL

Other: Individualized acupuncture treatment

Routine care

NO INTERVENTION

Other: Routine care

Interventions

Individualized acupuncture treatment OTHER

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)

Individualized acupuncture

Routine care OTHER

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.

Routine care

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Korea Institute of Oriental Medicine: lead

Study Sites (2)

Korea Institute of Oriental Medicine (Clinical Research Center)

Daejeon, 305-811, South Korea

Location

Korea Institute of Oriental Medicine

Daejeon, 305-811, South Korea

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Renal Insufficiency, Chronic; Pain

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Kun Hyung Kim, MS

  Korea Institute of Oriental Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: April 9, 2010
• First Posted: April 13, 2010
• Study Start: May 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: April 1, 2011
• Last Updated: January 26, 2011

Record last verified: 2011-01

Locations

KR (2)