Effects of Electroacupuncture to Relieve Itching Degree in Patients With Chronic Atopic Eczema

September 3, 2022 updated by: Shanghai Yueyang Integrated Medicine Hospital

Effects of Electroacupuncture to Relieve Itching Degree in Patients With Chronic Atopic Eczema: Study Protocol for a Randomized Multicenter, Sham Electroacupuncture, Clinical Trial

Eczema is a common allergic skin disease, accounting for about 15 to 30% of dermatological outpatients. Pruritus as one of the most painful symptoms is often underestimated in terms of the problems that it can cause, which creates the vicious loop of itching, scratching, and lichenification. Therefore, further research into practical and safe treatments that eliminate itchy symptoms and enhance skin protection is the key to overcoming chronic atopic eczema. Acupuncture has been utilized clinically in China for thousands of years due to its benefits of being practical, affordable, and simple to execute. With modern science and technology advancements, electroacupuncture (AE) has become widely used in China's public hospitals to treat chronic atopic eczema. This trial aims to objectively evaluate the clinical efficacy and safety of the electroacupuncture antipruritic technique in chronic atopic eczema pruritus and to obtain its high-level clinical evidence for the popularization and application of electroacupuncture clinical treatment of chronic atopic eczema.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

As a common allergic skin disease, the incidence of eczema is increasing year by year, accounting for about 15 ~ 30% of the dermatological outpatients. Pruritus is one of the most painful symptoms of eczema. Patients often form a vicious circle of "pruritus -- scratching -- mossy transformation" because they can't stand it. Research on safe and effective anti-pruritus program has become the key to treatment. Inheriting the experience of Xia's surgery in Shanghai, the team proposed the core pathogenesis of "blood heat and dampness heat", formulated the treatment principle of "cooling blood dehumidification", selected acupoints Quchi (LI4), Hegu (LI11), Xuehai (SP10) and Sanyi jiao (SP6), and used the original acupuncture anti-pruritus technique (modified by acupuncture anesthesia technique) to treat chronic eczema with clinical advantages. Small sample Pilot study showed that acupuncture antipruritic technique significantly reduced the visual analogue scale (VAS) score of patients with chronic eczema, which was significantly better than sham EA group and non-EA group. This project adopts the multicenter, randomized, including false contrast design, objective, normative evaluation of acupuncture for chronic eczema itching itching and technology to improve situation, clinical efficacy and safety, obtain exact clinical evidence, further to form suitable for standardization, popularization and application in wide range of chronic eczema itching technology clinical acupuncture specification.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
126

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Meeting the TCM syndrome differentiation criteria and Western medicine diagnostic criteria for chronic eczema;
  2. between the ages of 18 and 65;
  3. BSA score < 10%;
  4. Agree to participate in clinical trial observation and cooperate with regular visitors;
  5. Sign and date the informed consent;

Exclusion Criteria:

  1. Patients who have been systematically treated with hormones or immunosuppressants within two weeks;
  2. Recipients who are not durable to acupuncture;
  3. Patients with severe secondary infection symptoms, including local skin infection and systemic infection of other organs;
  4. Women who are pregnant, breastfeeding or planning to become pregnant during the trial;
  5. Diabetes mellitus or patients with severe heart, liver and kidney disease;
  6. Those who have received other research drugs or participated in other clinical trials within 3 months;
  7. Unable to cooperate with the research for any reason, such as: language comprehension, unable to go to the research center for treatment, etc.;
  8. Patients with generalized eczema, skin lesions all over the body and inconvenient for acupuncture;
  9. Acute onset of chronic eczema.
  10. BSA score ≥10%.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: electroacupuncture(EA) group
The participants in EA group will receive acupuncture with PSD at bilateral Hegu (LI4), bilateral Quchi (LU5), bilateral Xuehai (SP10) and bilateral San Yinjiao (SP6). After skin disinfection, followed at an angle of 90°, acupuncture needles were inserted approximately 50 to 60 mm into the skin. When achieving qi, connect the four pairs of electrodes, two each on bilateral Quchi (LI4) and Hegu (LI11), two each on bilateral Xuehai (SP10) and San Yinjiao (SP6), and they are all ipsilateral to one another. The duration of the electroacupuncture stimulation is 30 minutes, and the current intensity ranges from 1 to 5 mA with a continuous wave of 20 Hz. For two weeks straight, the participants will have three therapy sessions each week (preferably every other day), for a total of six sessions.
Device: electroacupunture
The participants in EA group will receive acupuncture with PSD at bilateral Hegu (LI4), bilateral Quchi (LU5), bilateral Xuehai (SP10) and bilateral San Yinjiao (SP6). After skin disinfection, followed at an angle of 90°, acupuncture needles were inserted approximately 50 to 60 mm into the skin. When achieving qi, connect the four pairs of electrodes, two each on bilateral Quchi (LI4) and Hegu (LI11), two each on bilateral Xuehai (SP10) and San Yinjiao (SP6), and they are all ipsilateral to one another. The duration of the electroacupuncture stimulation is 30 minutes, and the current intensity ranges from 1 to 5 mA with a continuous wave of 20 Hz. For two weeks straight, the participants will have three therapy sessions each week (preferably every other day), for a total of six sessions.
Sham Comparator: sham electroacupuncture(SEA) group
Participants in the SEA group will receive sham electroacupuncture with PSD, but not energizing the electropuncture device. Procedures, electrode placements, and other treatment settings are the same as in the EA group but with no electricity output only.
Device: sham electroacupuncture
Participants in the SEA group will receive sham electroacupuncture with PSD, but not energizing the electropuncture device. Procedures, electrode placements, and other treatment settings are the same as in the EA group but with no electricity output only.
Placebo Comparator: sham acupuncture(SAC) group
Participants in the SAC group will receive sham acupuncture with PSD and PSN on sham acupoints (the non-meridian and non-acupuncture points). Procedures, electrode placements, and other treatment settings are the same as in the EA group but with no skin penetration, electricity output, or needle manipulation for achieving qi.
Device: sham acupuncture
Participants in the SAC group will receive sham acupuncture with PSD and PSN on sham acupoints (the non-meridian and non-acupuncture points). Procedures, electrode placements, and other treatment settings are the same as in the EA group but with no skin penetration, electricity output, or needle manipulation for achieving qi.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
the change from baseline in Visual Analogue Scale (VAS) scores
Time Frame: week0, week1, week2
Pruritus, as the main clinical symptom of eczema, can be scored separately as follows: Pruritus score standard: no pruritus =0; mild（Itchy, not scratching, not affecting daily life) = 1-3 points; Moderate (frequent pruritus, occasional scratching, affecting daily life and sleep) = 4-6 points; Severe (severe itching, frequent scratching, seriously affecting daily life and sleep) = 7-10 points.
week0, week1, week2

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Eczema Area and Severity Index, EASI
Time Frame: week0, week1, week2
week0, week1, week2
Dermatology Life Quality Index, DLQI
Time Frame: week1, week2
This index in the form of questionnaire, extent into very serious, serious, mild, not four grades, including skin have itch pain, skin problems due to the bad mood, affect normal life dating movement, cause inconvenience in daily life, such as problems, first by the clinic doctors to explain the survey on the patients, and then by patients according to the different problem corresponding to their own situation, Check the box in different degrees to complete the questionnaire independently.
week1, week2
Serum total IgE
Time Frame: week1, week2
week1, week2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Yueyang Integrated Medicine Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 30, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2025

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 27, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 7, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 7, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 22Y11922200

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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