PruritusNCT02432508
Efficacy of Laser Acupuncture on Pruritus in Patients With Chronic Kidney Disease Undergoing Hemodialysis
A study testing Laser acupuncture (Olympic) in people with Pruritus and Kidney Failure, Chronic, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
Uremic pruritus is a clinically significant symptom which imposes heavy impact on the quality of life of patients with chronic kidney disease undergoing hemodialysis. In order to investigate the clinical efficacy and mechanism, the investigators designed a multiple centers, randomized, assessor- and participant-blind… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pruritus, Kidney Failure, Chronic
- What is being tested?
- Laser acupuncture (Olympic)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2014to Dec 2016
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age>20y/o, ESRD patient, pruritus symptoms persist longer than 4 weeks
Who cannot join
- immunosupression agents use, undergo chemotherapy
- drug abuser
- pregnancy women
- patient with psychiological disorder
- arrhythemia, pacemaker device use
- local skin infection over laser acupuncture site
- patient allergy to laser acupuncture treament
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Hospital
Taichung, Taichung, 420
Chang Chiz-Tzung, Ph.D., 886 0422052121 ext. 3483, D19863@mail.cmuh.org.tw
About this study
Official title: Efficacy of Laser Acupuncture on Pruritus in Patients With Chronic Kidney Disease Undergoing Hemodialysis: A Multiple Centers, Randomized, Assessor- and Participant-blind, Controlled, Cross-over Clinical Trial
Uremic pruritus is a clinically significant symptom which imposes heavy impact on the quality of life of patients with chronic kidney disease undergoing hemodialysis. In order to investigate the clinical efficacy and mechanism, the investigators designed a multiple centers, randomized, assessor- and participant-blind, controlled, cross-over clinical trial. This trial will be conducted at Taichung branch, Feng-yuan branch and the Eastern branch of CMUH.
Read the detailed description
We plan to enroll 200 volunteer patients with uremic pruritus. After the waiting period (as the waiting list group), you will be randomized to laser acupuncture and sham laser acupuncture group. Each group will include 100 patients and given intervention according to their hemodialysis frequency, i.e., BIW or TIW. The intervention will then be crossed over to the other one after 4 week of wash-our period. Outcome measurement includes questionnaires, biochemistry analysis, instrumental analysis and medication score.
- Conditions
- Pruritus, Kidney Failure, Chronic
- Being tested
- Laser acupuncture (Olympic), Sham Laser acupuncture (Olympic)
- Keywords
- acupuncture, laser, uremic pruritus, randomized clinical trial
- Medical subject headings
- Pruritus, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser acupuncture (Olympic)Device
Physiolaser Olympic laser acupuncture device (50mW, 655nm)
Sham Laser acupuncture (Olympic)Device
Physiolaser Olympic laser acupuncture device (Low dose of laser energy: 5mW, 655nm)
| Study group | Role | What they receive |
|---|---|---|
| laser acupuncture | Active comparator | One hundreds of hemodialysis patients include and give intervention with laser acupuncture (50mW) for 4 weeks. After 4 weeks of wash out period, these patients cross over to shame laser acupuncture treatment (5mW). Receives: Device: Laser acupuncture (Olympic); Device: Sham Laser acupuncture (Olympic) |
| sham laser acupuncture | Sham comparator | One hundreds of hemodialysis patients include and give intervention with sham laser acupuncture (5mW) for 4 weeks. After 4 weeks of wash out period, these patients cross over to laser acupuncture treatment (50mW). Receives: Device: Laser acupuncture (Olympic); Device: Sham Laser acupuncture (Olympic) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pruritus Visual Analogue Scale
We plan to enroll 200 volunteer patients with uremic pruritus. After the waiting period (4weeks), the patients will be randomized to laser acupuncture and sham laser acupuncture group (4weeks). Each group will include 100 patients and given intervention according to their hemodialysis frequency, i.e., BIW or TIW. The intervention will then be crossed over to the other one after 4 week of wash-our period. Outcome measurement includes questionnaires, biochemistry analysis, instrumental analysis and medication score will perform in the last 4 weeks.
Pruritus Visual Aaalogue Scale questionnaire will perform on each visit of hemodialysis.
Measured: 20 weeks
Secondary outcomes (5)
Short-Form-36 Health Survey (SF-36)
SF-36 questionnaire will perform in the begin, 4th, 8th, 12th, 16th and 20th week.
Measured: 20 weeks
Dermatology Life Quality Index (DLQI)
DLQI questionnaire will perform in the begin, 4th, 8th, 12th, 16th and 20th week.
Measured: 20 weeks
The 5-D itch scale
The 5-D itch scale will perform in the begin, 4th, 8th, 12th, 16th and 20th week.
Measured: 20 weeks
The Pittsburgh Sleep Quality Index; PSQI
PSQI will perform in the begin, 4th, 8th, 12th, 16th and 20th week.
Measured: 20 weeks
Beck Depression Inventory, BDI
BDI will perform in the begin, 4th, 8th, 12th, 16th and 20th week.
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2015 (estimated)
- Study startOct 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
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 PruritusStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chang Chiz-Tzung, Ph.D., Study chair, School of Medicine, China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02432508
- Sponsor's protocol ID
- A-3-2-A/CMUH103-REC2-112
- Status last verified
- Apr 2015
- First submitted
- 18 Jan 2015
- Last updated
- 4 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2.
PubMed 33283264
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Laser Acupuncture on Pruritus in Patients With Chronic Kidney Disease Undergoing Hemodialysis: A Multiple Centers, Randomized, Assessor- and Participant-blind, Controlled, Cross-over Clinical Trial
- ClinicalTrials.gov ID
- NCT02432508
- Acronym / sponsor ID
- A-3-2-A/CMUH103-REC2-112
- Conditions
- Pruritus, Kidney Failure, Chronic
- Keywords
- acupuncture, laser, uremic pruritus, randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 4 May 2015 (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.
Uremic pruritus is a clinically significant symptom which imposes heavy impact on the quality of life of patients with chronic kidney disease undergoing hemodialysis. In order to investigate the clinical efficacy and mechanism, the investigators designed a multiple centers, randomized, assessor- and participant-blind, controlled, cross-over clinical trial. This trial will be conducted at Taichung branch, Feng-yuan branch and the Eastern branch of CMUH.
Detailed description
We plan to enroll 200 volunteer patients with uremic pruritus. After the waiting period (as the waiting list group), you will be randomized to laser acupuncture and sham laser acupuncture group. Each group will include 100 patients and given intervention according to their hemodialysis frequency, i.e., BIW or TIW. The intervention will then be crossed over to the other one after 4 week of wash-our period. Outcome measurement includes questionnaires, biochemistry analysis, instrumental analysis and medication score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laser acupuncture | Active comparator | Device: Laser acupuncture (Olympic), Device: Sham Laser acupuncture (Olympic)One hundreds of hemodialysis patients include and give intervention with laser acupuncture (50mW) for 4 weeks. After 4 weeks of wash out period, these patients cross over to shame laser acupuncture treatment (5mW). |
| sham laser acupuncture | Sham comparator | Device: Laser acupuncture (Olympic), Device: Sham Laser acupuncture (Olympic)One hundreds of hemodialysis patients include and give intervention with sham laser acupuncture (5mW) for 4 weeks. After 4 weeks of wash out period, these patients cross over to laser acupuncture treatment (50mW). |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age>20y/o, ESRD patient, pruritus symptoms persist longer than 4 weeks
Key exclusion criteria (7 listed)
- immunosupression agents use, undergo chemotherapy
- drug abuser
- pregnancy women
- patient with psychiological disorder
- arrhythemia, pacemaker device use
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 |
|---|---|---|
| Laser acupuncture (Olympic)Physiolaser Olympic laser acupuncture device (50mW, 655nm) | Device | laser acupuncture, sham laser acupuncture |
| Sham Laser acupuncture (Olympic)Physiolaser Olympic laser acupuncture device (Low dose of laser energy: 5mW, 655nm) | Device | laser acupuncture, sham laser acupuncture |
Primary outcome
Pruritus Visual Analogue Scale
Time frame: 20 weeks
We plan to enroll 200 volunteer patients with uremic pruritus. After the waiting period (4weeks), the patients will be randomized to laser acupuncture and sham laser acupuncture group (4weeks). Each group will include 100 patients and given intervention according to their hemodialysis frequency, i.e., BIW or TIW. The intervention will then be crossed over to the other one after 4 week of wash-our period. Outcome measurement includes questionnaires, biochemistry analysis, instrumental analysis and medication score will perform in the last 4 weeks. Pruritus Visual Aaalogue Scale questionnaire will perform on each visit of hemodialysis.
5 secondary outcomes
Short-Form-36 Health Survey (SF-36)
Time frame: 20 weeks
Dermatology Life Quality Index (DLQI)
Time frame: 20 weeks
The 5-D itch scale
Time frame: 20 weeks
The Pittsburgh Sleep Quality Index; PSQI
Time frame: 20 weeks
Beck Depression Inventory, BDI
Time frame: 20 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2015.
- Derived from this study: PubMed 33283264Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2.
Related trials for Pruritus
Recruiting
Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
Histamine, Cowhage
Active, not recruiting
Identification of the Mechanism of Non-histaminergic Itch Inducing Epigenetic Changes
Itch
Recruiting
Investigate the Relationship Between Catastrophizing and the Perception of Itch Intensity in Healthy Individuals
Histamine, Cowhage
RecruitingPhase 3
Roflumilast Cream 0.3% for Moderate to Severe Atopic Dermatitis
Atopic Dermatitis, Atopic Dermatitis (AD)
Recruiting
Topographical Distribution of Itch and Pain Receptors
Pain, Itch
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.
Chang Chiz-Tzung, Ph.D. study chair
School of Medicine, China Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser acupuncture (Olympic) in people with Pruritus and Kidney Failure, Chronic, run by China Medical University Hospital at 1 site in Taiwan.
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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 4 May 2015. 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 Taiwan. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chang Chiz-Tzung, Ph.D. (886 0422052121 ext. 3483, D19863@mail.cmuh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pruritus Visual Analogue Scale (time frame: 20 weeks). 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 NCT02432508, 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 4 May 2015.