Ignite Creation Date:
2024-05-06 @ 8:52 AM
Last Modification Date:
2024-10-26 @ 12:06 PM
Study NCT ID:
NCT02844452
Status:
COMPLETED
Last Update Posted:
2018-04-17
First Post:
2016-07-15
Brief Title:
Antipruritic Effect of Acupuncture in Patients With Atopic Dermatitis
Sponsor:
Kyunghee University
Organization:
Kyunghee University
Study Overview
Official Title:
Antipruritic Effect of Acupuncture in Patients With Atopic Dermatitis Feasibility Study Protocol for a Randomised Sham-Controlled Trial
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Introduction Atopic dermatitis AD is a chronic relapsing inflammatory skin disease inducing poor quality of life Its conventional treatments often cause unsatisfactory relief and adverse effects in long-term application Acupuncture treatment is regarded to have a curative effect on AD symptoms The aim of this trial is to evaluate the therapeutic effects of acupuncture on AD symptoms including pruritus and poor quality of life in patients with AD
Method and Analysis This trial is a randomized sham-controlled pilot trial with different visit frequencies 30 eligible patients with atopic dermatitis will be randomly allocated in a ratio of 111 to the Verum Acupuncture group 1 VA1 3 days weekly Verum Acupuncture group 2 VA2 2 days weekly and Sham Acupuncture group 2 days weekly The acupuncture treatment will be given three or two times a week for 4 weeks according to the allocated groups The main outcome measures are Visual analogue scale for itch itch VAS SCORing Atopic Dermatitis SCORAD and Eczema Area and Severity Index EASI to evaluate the improvement of AD symptoms and Patient Oriented Eczema Measure POEM Dermatology Life Quality Index DLQI to assess the quality of life of AD patients It will be measured at baseline once a week during treatment period and after follow-up period
EthicsDissemination This protocol was approved by the Institutional Review Boards at Kyung Hee University Korean Medicine Hospital on May 2016 The permission number is KOMCIRB-160212-HRBR-004 This trial will provide the data of therapeutic effects of treating atopic dermatitis with acupuncture in accordance with the different visit frequencies The outcomes will be facilitated to calculate the sample size of further study with the same design of this study The findings from this trial will be published and presented in conference
Method and Analysis This trial is a randomized sham-controlled pilot trial with different visit frequencies 30 eligible patients with atopic dermatitis will be randomly allocated in a ratio of 111 to the Verum Acupuncture group 1 VA1 3 days weekly Verum Acupuncture group 2 VA2 2 days weekly and Sham Acupuncture group 2 days weekly The acupuncture treatment will be given three or two times a week for 4 weeks according to the allocated groups The main outcome measures are Visual analogue scale for itch itch VAS SCORing Atopic Dermatitis SCORAD and Eczema Area and Severity Index EASI to evaluate the improvement of AD symptoms and Patient Oriented Eczema Measure POEM Dermatology Life Quality Index DLQI to assess the quality of life of AD patients It will be measured at baseline once a week during treatment period and after follow-up period
EthicsDissemination This protocol was approved by the Institutional Review Boards at Kyung Hee University Korean Medicine Hospital on May 2016 The permission number is KOMCIRB-160212-HRBR-004 This trial will provide the data of therapeutic effects of treating atopic dermatitis with acupuncture in accordance with the different visit frequencies The outcomes will be facilitated to calculate the sample size of further study with the same design of this study The findings from this trial will be published and presented in conference
Detailed Description:
Objectives This pilot study aims to investigate the feasibility of validating the anti-pruritic effectiveness of the sole acupuncture intervention and the efficacy of different frequent treatments of acupuncture and discovering noble candidates of a specific biomaterial associated with the development of atopic dermatitis Moreover the result will be facilitated in calculating the sample size on the further study
Trial design A randomized sham-controlled different intervention frequency trial will be conducted at the Kyung Hee University Korean Medicine Hospital from June to November 2016
Participants and Recruitment
Recruitment Acquiring consent will be conducted by the investigators with the principle of informed consent which confirms participants voluntarism The participants will sign the document made of general consent form and additional consent provisions for blood collection and use of their human derived material first of all The exemplary consent paper and other related literature can be offered upon request
Randomization and allocation concealment The AD patients will be randomized to one of the three groups via block randomization
An independent statistician will product random numbers with the PROC PLAN of SAS 92 SAS institute Inc Cary NC USA and transfer them to the Acupuncture and Meridian Science Research Center AMSRC at Kyung Hee University where the each randomization number will be sealed in a sequentially numbered non-transparent envelope by a staff uninvolved in this study
At the beginning of the randomization process the investigator will call the independent staff in AMSRC to pass the screening number of the participant Then the AMSRC staff immediately assign the participating patient to one of three groups by unsealing a numbered envelope It will be documented in the trial master file thoroughly
Blinding The participating patients and the assessor will be blinded to the group allocation of patients in this trial It is impossible for acupuncturists to be unaware of the group assignments but they will not perform the outcome measurements or data analyses
To prevent a possible bias the eye patch will be applied for the patients during the acupuncture treatment and they will be unable to see the practice procedures All the acupuncture treatment regardless of the group assignment will be practiced by using Park sham devices AcuPrime Co Ltd Exeter UK which is attached on the applied acupoints as to block the sighting of penetrating or non-penetrating on the skin of acupuncture needles 9 The acupuncture needles and devices will be maintained for 15 min identically
Intervention Acupuncture treatment Both manual acupuncture treatment and acupressure would be conducted on every participating AD patient It was designed to become a pragmatic treatment procedure corresponding with real clinic settings
In this study the manual acupuncture treatment is composed of basic acupuncture treatment and additional acupuncture treatment partially individualized acupuncture treatment will be conducted on the basis of the traditional meridian theory and consensus by the experts in acupuncture and the atopic disease The number of applied acupoints per patient per session ranges from 6 to 19 The optional points include ST43 GB41 LI2 TE3 SI3 TE6 SI2 BL66 LR3 and SP3
The clinical research coordinator will ask the symptoms associated with additional acupuncture treatment to reduce the bias The acupuncture treatment will be practiced with a sterilized stainless needle 40 mm length and 025 mm diameter Dongbang Acupuncture Inc Bundang Sungnam Korea by one same Korean Medicine Docter Manipulation technique will be performed to elicit de qi sensation The needle will be inserted in depth of 5 to 30 mm and retained for 15 minute
Acupressure technique will be taken after the elimination of stainless needles The 15 mm press tack needles Haeng Lim Seo Won Medical co China will be attached on four acupoints per participating patient per session LI11 bilaterally and auricular-Shenmen contralaterally It was designed with the traditional meridian theory and consensus by the experts in acupuncture and the atopic disease The patients will be instructed by the involved staff to press the applied press tack needles located on LI11 when they feel severe pruritus for 3 min
All the acupuncture practice will be carried out by the same Korean Medicine Doctor who will be trained for 10 hours to guarantee that he could perform the identical acupuncture treatment according to the pre-constructed protocol
Dropout criteria on patients visits During the study period each patient will visit 12 or 8 treatment sessions according to allocated group Since frequent visit would be the burden to participating patients and cause absences from the trial we made the criteria on the absence of participants of each group and the range of dropout Acupuncture group 1 which have total 12 acupuncture treatment ought to complete 10 treatment sessions to minimum and acupuncture group 2 and sham acupuncture group which have total 8 acupuncture treatment ought to complete 6 sessions Each treatment session of all the allocated group cannot be delayed over 6 days from the previous session
Outcome measures One health care provider involved in this study will conduct a series of outcome measures There will be no separation between primary and secondary outcome since it is an exploratory pilot study to search independent effectiveness of acupuncture intervention on atopic dermatitis and secure a dataset for the further study
SCORAD index Itch VAS EASI score POEM DLQI CES-D STAXI
Investigating biomaterials with blood collection Serum total IgE measurement Serum cytokinechemokines measurement Serum cortisol measurement MicroRNA microarray
Statistical Methods Sample size calculation The current trial was established as a pilot study to investigate the anti-pruritic effects of acupuncture for the patients with atopic disease A total of 30 AD patients 10 in each group and 20 healthy controls will be recruited during the study period in regard of 20 dropout rate Its outcomes will suggest evidences for feasibility of further large-scale study and sample size calculation
Statistical analysis A statistician uninvolved in the research team will take charge of the statistical analysis by using the SPSS 210 IBM SPSS Statistics New York USA Categorical variables will be provided with percentages and continuous variables will be provided as mean and standard deviation
The intervention effectiveness will be analyzed with the changes between the baseline and the end of treatment period or follow-up period Data analysis of baseline characteristics between allocated groups will be compared through a repeated-measures analysis of variance ANOVA test and χ2 test respectively on continuous variables and categorical variables
The different efficiency according to three times or twice weekly acupuncture treatment will be analyzed with the changes in itch VAS and SCORAD index by the Mann-Whitney U-test on continuous variables and χ2 test on categorical variables The difference on therapeutic efficiency between verum acupuncture treatment groups and sham acupuncture treatment group will be investigated in the same way And these outcome data will be analyzed with 01 two-sided statistical significance level and the 90 confidence intervals regarding with the professional advice for the small sample size For the further study the difference on treatment groups and control group will be applied to calculate the number of needed participants with a set on 005 α and 80 power
Protection of human subjects Ethical approval and registration This study protocol was approved by the Institutional Review Boards at Kyung Hee University Korean Medicine Hospital KOMCIRB-160212-HRBR-004 It will be performed in accordance with the standards of the International Committee on Harmonization on Good Clinical Practice and the revised version of the Declaration of Helsinki
Trial design A randomized sham-controlled different intervention frequency trial will be conducted at the Kyung Hee University Korean Medicine Hospital from June to November 2016
Participants and Recruitment
Recruitment Acquiring consent will be conducted by the investigators with the principle of informed consent which confirms participants voluntarism The participants will sign the document made of general consent form and additional consent provisions for blood collection and use of their human derived material first of all The exemplary consent paper and other related literature can be offered upon request
Randomization and allocation concealment The AD patients will be randomized to one of the three groups via block randomization
An independent statistician will product random numbers with the PROC PLAN of SAS 92 SAS institute Inc Cary NC USA and transfer them to the Acupuncture and Meridian Science Research Center AMSRC at Kyung Hee University where the each randomization number will be sealed in a sequentially numbered non-transparent envelope by a staff uninvolved in this study
At the beginning of the randomization process the investigator will call the independent staff in AMSRC to pass the screening number of the participant Then the AMSRC staff immediately assign the participating patient to one of three groups by unsealing a numbered envelope It will be documented in the trial master file thoroughly
Blinding The participating patients and the assessor will be blinded to the group allocation of patients in this trial It is impossible for acupuncturists to be unaware of the group assignments but they will not perform the outcome measurements or data analyses
To prevent a possible bias the eye patch will be applied for the patients during the acupuncture treatment and they will be unable to see the practice procedures All the acupuncture treatment regardless of the group assignment will be practiced by using Park sham devices AcuPrime Co Ltd Exeter UK which is attached on the applied acupoints as to block the sighting of penetrating or non-penetrating on the skin of acupuncture needles 9 The acupuncture needles and devices will be maintained for 15 min identically
Intervention Acupuncture treatment Both manual acupuncture treatment and acupressure would be conducted on every participating AD patient It was designed to become a pragmatic treatment procedure corresponding with real clinic settings
In this study the manual acupuncture treatment is composed of basic acupuncture treatment and additional acupuncture treatment partially individualized acupuncture treatment will be conducted on the basis of the traditional meridian theory and consensus by the experts in acupuncture and the atopic disease The number of applied acupoints per patient per session ranges from 6 to 19 The optional points include ST43 GB41 LI2 TE3 SI3 TE6 SI2 BL66 LR3 and SP3
The clinical research coordinator will ask the symptoms associated with additional acupuncture treatment to reduce the bias The acupuncture treatment will be practiced with a sterilized stainless needle 40 mm length and 025 mm diameter Dongbang Acupuncture Inc Bundang Sungnam Korea by one same Korean Medicine Docter Manipulation technique will be performed to elicit de qi sensation The needle will be inserted in depth of 5 to 30 mm and retained for 15 minute
Acupressure technique will be taken after the elimination of stainless needles The 15 mm press tack needles Haeng Lim Seo Won Medical co China will be attached on four acupoints per participating patient per session LI11 bilaterally and auricular-Shenmen contralaterally It was designed with the traditional meridian theory and consensus by the experts in acupuncture and the atopic disease The patients will be instructed by the involved staff to press the applied press tack needles located on LI11 when they feel severe pruritus for 3 min
All the acupuncture practice will be carried out by the same Korean Medicine Doctor who will be trained for 10 hours to guarantee that he could perform the identical acupuncture treatment according to the pre-constructed protocol
Dropout criteria on patients visits During the study period each patient will visit 12 or 8 treatment sessions according to allocated group Since frequent visit would be the burden to participating patients and cause absences from the trial we made the criteria on the absence of participants of each group and the range of dropout Acupuncture group 1 which have total 12 acupuncture treatment ought to complete 10 treatment sessions to minimum and acupuncture group 2 and sham acupuncture group which have total 8 acupuncture treatment ought to complete 6 sessions Each treatment session of all the allocated group cannot be delayed over 6 days from the previous session
Outcome measures One health care provider involved in this study will conduct a series of outcome measures There will be no separation between primary and secondary outcome since it is an exploratory pilot study to search independent effectiveness of acupuncture intervention on atopic dermatitis and secure a dataset for the further study
SCORAD index Itch VAS EASI score POEM DLQI CES-D STAXI
Investigating biomaterials with blood collection Serum total IgE measurement Serum cytokinechemokines measurement Serum cortisol measurement MicroRNA microarray
Statistical Methods Sample size calculation The current trial was established as a pilot study to investigate the anti-pruritic effects of acupuncture for the patients with atopic disease A total of 30 AD patients 10 in each group and 20 healthy controls will be recruited during the study period in regard of 20 dropout rate Its outcomes will suggest evidences for feasibility of further large-scale study and sample size calculation
Statistical analysis A statistician uninvolved in the research team will take charge of the statistical analysis by using the SPSS 210 IBM SPSS Statistics New York USA Categorical variables will be provided with percentages and continuous variables will be provided as mean and standard deviation
The intervention effectiveness will be analyzed with the changes between the baseline and the end of treatment period or follow-up period Data analysis of baseline characteristics between allocated groups will be compared through a repeated-measures analysis of variance ANOVA test and χ2 test respectively on continuous variables and categorical variables
The different efficiency according to three times or twice weekly acupuncture treatment will be analyzed with the changes in itch VAS and SCORAD index by the Mann-Whitney U-test on continuous variables and χ2 test on categorical variables The difference on therapeutic efficiency between verum acupuncture treatment groups and sham acupuncture treatment group will be investigated in the same way And these outcome data will be analyzed with 01 two-sided statistical significance level and the 90 confidence intervals regarding with the professional advice for the small sample size For the further study the difference on treatment groups and control group will be applied to calculate the number of needed participants with a set on 005 α and 80 power
Protection of human subjects Ethical approval and registration This study protocol was approved by the Institutional Review Boards at Kyung Hee University Korean Medicine Hospital KOMCIRB-160212-HRBR-004 It will be performed in accordance with the standards of the International Committee on Harmonization on Good Clinical Practice and the revised version of the Declaration of Helsinki
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None