End-stage Renal DiseaseNCT01102816
Acupuncture for Pain Management of Hemodialysis Patients
A study testing Individualized acupuncture treatment and Routine care in people with End-stage Renal Disease and Chronic Kidney Disease, run by Korea Institute of Oriental Medicine at 2 sites in South Korea.
Trial summary
The purpose of this study is to determine the feasibility, effectiveness and safety of acupuncture for pain management in hemodialysis patients. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- End-stage Renal Disease, Chronic Kidney Disease
- What is being tested?
- Individualized acupuncture treatment and Routine care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 2 sitesSouth Korea
- Study dates
- May 2010to Apr 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Korea Institute of Oriental Medicine (Clinical Research Center)
Daejeon, 305-811
Korea Institute of Oriental Medicine
Daejeon, 305-811
About this study
Official title: Acupuncture for Pain Management of Hemodialysis Patients: a Randomized, Controlled Pilot Study
The purpose of this study is to determine the feasibility, effectiveness and safety of acupuncture for pain management in hemodialysis patients.
Read the 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.
- Conditions
- End-stage Renal Disease, Chronic Kidney Disease
- Being tested
- Individualized acupuncture treatment, Routine care
- Keywords
- hemodialysis, end-stage renal disease, pain, acupuncture
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency, Chronic, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized acupuncture treatmentOther
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)
Routine careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Individualized acupuncture | Experimental | Not described Receives: Other: Individualized acupuncture treatment |
| Routine care | No intervention | Not described Receives: Other: Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (3)
Depressive moods measured by Beck Depression Inventory (BDI)
Follow-up evaluation will be conducted after 6 weeks from post-treatment measurement.
Measured: 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.
Measured: 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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2010 (estimated)
- Study startMay 2010
- Primary completionFeb 2011 (estimated)
- Study completionApr 2011 (estimated)
Why it stopped: We failed to recruit enough patients by regular recruitment methods (i.e., newspaper ads, hospital postings, radios and television ads).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea Institute of Oriental Medicine
- Sponsor type
- Other government
- Investigators
- Kun Hyung Kim, MS, Principal investigator, Korea Institute of Oriental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01102816
- Sponsor's protocol ID
- KI0908
- Other IDs
- KI0908
- Status last verified
- Jan 2011
- First submitted
- 9 Apr 2010
- Last updated
- 26 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for Pain Management of Hemodialysis Patients: a Randomized, Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT01102816
- Acronym / sponsor ID
- KI0908
- Conditions
- End-stage Renal Disease, Chronic Kidney Disease
- Keywords
- hemodialysis, end-stage renal disease, pain, acupuncture
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: We failed to recruit enough patients by regular recruitment methods (i.e., newspaper ads, hospital postings, radios and television ads).
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Korea Institute of Oriental MedicineOther government
- Study start
- May 2010
- Primary completion
- Feb 2011 (estimated)
- Study completion
- Apr 2011 (estimated)
- First posted
- 13 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individualized acupuncture | Experimental | Other: Individualized acupuncture treatment |
| Routine care | No intervention | Other: Routine care |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized acupuncture treatmentIndividualized 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) | Other | Individualized acupuncture |
| Routine carePatients 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. | Other | Routine care |
Primary outcome
Pain measured on 0-6 scale of symptom 1 subscale score in the Measure Your Medical Outcome Profile2 (MYMOP2) questionnaire.
Time frame: 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.
3 secondary outcomes
Depressive moods measured by Beck Depression Inventory (BDI)
Time frame: 6 weeks
Quality of life of patients measured by Kidney Disease Quality of Life Version 1.3 (KDQOL-V 1.3)
Time frame: 6 weeks
Other patient-perceived changes on health and daily life measured by the MYMOP2
Time frame: 6 weeks
Results and safety
The study was stopped early (reason given: We failed to recruit enough patients by regular recruitment methods (i.e., newspaper ads, hospital postings, radios and television ads).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kun Hyung Kim, MS principal investigator
Korea Institute of Oriental Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized acupuncture treatment and Routine care in people with End-stage Renal Disease and Chronic Kidney Disease, run by Korea Institute of Oriental Medicine at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: We failed to recruit enough patients by regular recruitment methods (i.e., newspaper ads, hospital postings, radios and television ads).). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain measured on 0-6 scale of symptom 1 subscale score in the Measure Your Medical Outcome Profile2 (MYMOP2) questionnaire. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2011.