HemodialysisNCT00883831
The Effectiveness and the Safety of Acupuncture for Symptomatic Care of Hemodialysis Patients: A Case-series
A study testing Individualized manual acupuncture in people with Hemodialysis and End Stage Renal Disease, run by Korea Institute of Oriental Medicine at 1 site in South Korea.
Trial summary
Purpose: Hemodialysis-dependent patients with an end-stage renal disease (ESRD) suffer from a number of distressing symptoms, such as pain, poor mental health, fatigue, sleep disturbance and pruritus. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hemodialysis, End Stage Renal Disease
- What is being tested?
- Individualized manual acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2009to Jan 2010
- 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
- over 19 years old
- started hemodialysis at least 3 months ago
- receiving hemodialysis 3 times a week regularly
- equilibrated Kt/V ≥ 1.2
- 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
- hemorrhagic disorders
- drug abuse/alcoholism
- other infectious disease including active tuberculosis
- history of the use of acupuncture, moxibustion or herbs within 1 month
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Doonsan Oriental Hospital of Daejeon University
Daejeon, 302-869
About this study
Official title: Acupuncture for Symptomatic Care of Hemodialysis Patients: a Case-series
Purpose:
Hemodialysis-dependent patients with an end-stage renal disease (ESRD) suffer from a number of distressing symptoms, such as pain, poor mental health, fatigue, sleep disturbance and pruritus. These negatively influence health-related quality of life in ESRD patients, and some of them result in increased mortality and hospitalization. Acupuncture is a widely employed treatment on several chronic disease or condition. Adjunctive use of acupuncture with conventional treatment could be a possible therapeutic option to establish an optimal care for ESRD patients who experiences co-morbid conditions or complications of hemodialysis. Due to its non-pharmacologic feature, the effects of acupuncture without involving altered pharmacokinetics and drug-interactions in hemodialysis patients, might be another strong point compared to other pharmacological interventions. However, little information is available for the effects and the safety of acupuncture for symptomatic care of hemodialysis patients.
Thus, the investigators propose whether acupuncture could be a effective and safe therapeutic modality for a number of patient-reported symptoms in hemodialysis-dependent patients with ESRD.
Read the detailed description
This trial is a case-series, with a nested-qualitative study at the end of follow-up. Acupuncture treatment will be provided biweekly for 6 weeks, namely total 12 sessions, and follow-up period will be 4 weeks after the end of treatment. Changes of symptoms, quality of life and occured adverse events will be assessed during study procedure. Patients who agreed joining qualitative research will be interviewed about their experiences of acupuncture in detail.
- Conditions
- Hemodialysis, End Stage Renal Disease
- Being tested
- Individualized manual acupuncture
- Keywords
- Acupuncture, Hemodialysis, Symptom, end stage renal disease, chronic kidney disease, supportive care
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized manual acupunctureProcedure or surgery
Acupuncture treatment will be provided according to traditional korean medicine (TKM) theory which focuses on patient's individual symptoms and conditions. 10-12 needles will be inserted into acupuncture point on the body except one arm where arteriovenous fistula is located for hemodialysis access. Needle retention time will be 30 minutes with intermittent manual stimulation to elicit de-qi sensation. Biweekly treatment will be conducted at non-dialysis access day or before hemodialysis at dialysis-access day for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Individualized manual acupuncture | Experimental | Not described Receives: Procedure: Individualized manual acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure Your Medical Outcome Profile2 (MYMOP)
Measured: Evaluated at baseline, post-treatment, and 4 weeks after post-treatment (total 3 times)
Secondary outcomes (1)
Kidney Disease Quality of Life-SF V1.3 (KDQOL-SF V 1.3) questionnaire
Measured: Evaluated at baseline, post-treatment, and 4 weeks after post-treatment (total 3 times)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionDec 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemodialysisStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea Institute of Oriental Medicine
- Sponsor type
- Other government
- Investigators
- Sun Mi Choi, PhD, Principal investigator, Korea Institute of Oriental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00883831
- Sponsor's protocol ID
- KI0904
- Status last verified
- Apr 2009
- First submitted
- 17 Apr 2009
- Last updated
- 25 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Kim KH, Kim TH, Kang JW, Sul JU, Lee MS, Kim JI, Shin MS, Jung SY, Kim AR, Kang KW, Choi SM. Acupuncture for symptom management in hemodialysis patients: a prospective, observational pilot study. J Altern Complement Med. 2011 Aug;17(8):741-8. doi: 10.1089/acm.2010.0206. Epub 2011 Jul 1.
PubMed 21721925
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for Symptomatic Care of Hemodialysis Patients: a Case-series
- ClinicalTrials.gov ID
- NCT00883831
- Acronym / sponsor ID
- KI0904
- Conditions
- Hemodialysis, End Stage Renal Disease
- Keywords
- Acupuncture, Hemodialysis, Symptom, end stage renal disease, chronic kidney disease, supportive care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Korea Institute of Oriental MedicineOther government
- Study start
- Apr 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 20 Apr 2009 (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.
Purpose:
Hemodialysis-dependent patients with an end-stage renal disease (ESRD) suffer from a number of distressing symptoms, such as pain, poor mental health, fatigue, sleep disturbance and pruritus. These negatively influence health-related quality of life in ESRD patients, and some of them result in increased mortality and hospitalization. Acupuncture is a widely employed treatment on several chronic disease or condition. Adjunctive use of acupuncture with conventional treatment could be a possible therapeutic option to establish an optimal care for ESRD patients who experiences co-morbid conditions or complications of hemodialysis. Due to its non-pharmacologic feature, the effects of acupuncture without involving altered pharmacokinetics and drug-interactions in hemodialysis patients, might be another strong point compared to other pharmacological interventions. However, little information is available for the effects and the safety of acupuncture for symptomatic care of hemodialysis patients.
Thus, the investigators propose whether acupuncture could be a effective and safe therapeutic modality for a number of patient-reported symptoms in hemodialysis-dependent patients with ESRD.
Detailed description
This trial is a case-series, with a nested-qualitative study at the end of follow-up. Acupuncture treatment will be provided biweekly for 6 weeks, namely total 12 sessions, and follow-up period will be 4 weeks after the end of treatment. Changes of symptoms, quality of life and occured adverse events will be assessed during study procedure. Patients who agreed joining qualitative research will be interviewed about their experiences of acupuncture in detail.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individualized manual acupuncture | Experimental | Procedure: Individualized manual acupuncture |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- over 19 years old
- started hemodialysis at least 3 months ago
- receiving hemodialysis 3 times a week regularly
- equilibrated Kt/V ≥ 1.2
- willingness to participate in this study
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
- hemorrhagic disorders
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 manual acupunctureAcupuncture treatment will be provided according to traditional korean medicine (TKM) theory which focuses on patient's individual symptoms and conditions. 10-12 needles will be inserted into acupuncture point on the body except one arm where arteriovenous fistula is located for hemodialysis access. Needle retention time will be 30 minutes with intermittent manual stimulation to elicit de-qi sensation. Biweekly treatment will be conducted at non-dialysis access day or before hemodialysis at dialysis-access day for 6 weeks. | Procedure or surgery | Individualized manual acupuncture |
Primary outcome
Measure Your Medical Outcome Profile2 (MYMOP)
Time frame: Evaluated at baseline, post-treatment, and 4 weeks after post-treatment (total 3 times)
1 secondary outcome
Kidney Disease Quality of Life-SF V1.3 (KDQOL-SF V 1.3) questionnaire
Time frame: Evaluated at baseline, post-treatment, and 4 weeks after post-treatment (total 3 times)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2010.
- Derived from this study: PubMed 21721925Kim KH, Kim TH, Kang JW, Sul JU, Lee MS, Kim JI, Shin MS, Jung SY, Kim AR, Kang KW, Choi SM. Acupuncture for symptom management in hemodialysis patients: a prospective, observational pilot study. J Altern Complement Med. 2011 Aug;17(8):741-8. doi: 10.1089/acm.2010.0206. Epub 2011 Jul 1.
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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.
Sun Mi Choi, PhD principal investigator
Korea Institute of Oriental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized manual acupuncture in people with Hemodialysis and End Stage Renal Disease, run by Korea Institute of Oriental Medicine at 1 site 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 5 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: finished, as of the sponsor's last update on 25 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Measure Your Medical Outcome Profile2 (MYMOP) (time frame: Evaluated at baseline, post-treatment, and 4 weeks after post-treatment (total 3 times)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00883831, which also lists 1 linked publication.
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 25 Jan 2010.