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Intradermal Acupuncture Based on Changes in Biological Specificity of Acupoints for Major Depressive Disorder

Primary Purpose

Major Depressive Disorder

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Basic treatment

PSA

TSA

CCA

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Major depressive disorder, Intradermal acupuncture, Biological specificity

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Inclusion criteria for HC:

HC who could provide a recent depression screening report, and confirm they have not any cardiovascular, respiratory, digestive, urinary, hematological, endocrine, or neurological disease;
18 ≤ age ≤60 years, male or female;
Participants have clear consciousness and could communicate with others normally;
Participants could understand the full study protocol and have high adherence. Written informed consent is signed by themselves.

Inclusion criteria for MDD:

Patients should meet the diagnostic criteria of the International Classification of Diseases 10th Edition (ICD-10) diagnostic criteria for MDD;
18 ≤ age ≤60, male or female;
Participants have clear consciousness and could communicate with others normally;
Participants could understand the full study protocol and have high adherence. Written informed consent is signed by themselves.

Exclusion Criteria:

Exclusion criteria of HC:

Participants with serious primary diseases of cardiovascular diseases, liver diseases, kidney diseases, urinary diseases, and hematological diseases;
Participants have a mental illness, alcohol dependence, or a history of drug abuse;
Pregnant or lactating participants;
Participants with intellectual disabilities who cannot cooperate with the questionnaire survey;
Participants with bleeding tendency, skin disease, allergic constitution, and allergic to adhesive tape;
The skin at the test site of participants has scars, hyperpigmentation, red and swollen;
Participants are participating in other trials.

Exclusion criteria for MDD:

Participants with serious primary diseases of cardiovascular, respiratory, digestive, urinary, hematological, endocrine, neurological disease, and other serious primary diseases, and the disease cannot be effectively controlled clinically;
MDD caused by organic mental disorders, schizophrenia, bipolar disorder, psychoactive substances, and non-addictive substances;
Participants with suicidal tendencies;
Pregnant or lactating participants;
Participants with intellectual disabilities who cannot cooperate with the questionnaire survey;
Participants with bleeding tendency, skin disease, allergic constitution, and allergic to adhesive tape;
The skin at the test site of participants has scars, hyperpigmentation, red and swollen. IRT is not be performed on female subjects during their menstrual and ovulatory periods;
Participants are participating in other trials.

Sites / Locations

the Third affiliated hospital of Zhejiang Chinese Medical universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Arm Label

WT group

CCA group

TSA group

PSA group

Arm Description

This group will include 30 patients with MDD. Patients in this group will not receive IA treatment during the study period. When the study is over, they will receive 6 weeks of the same IA treatment as in the CCA group.

This group will include 30 patients with MDD who will be treated with basic treatment and IA. LR3, PC6, SP6, and HT7 will be selected for IA.

This group will include 30 patients with MDD who will be treated with basic treatment and IA. TSA selected in the first part of the study will be stimulated.

This group will include 30 patients with MDD who will be treated with basic treatment and IA. PSA selected in the first part of the study will be stimulated.

Outcomes

Primary Outcome Measures

Change in the Patient Health Questionaire-9 Items (PHQ -9)

The PHQ-9 scale has a total of 9 questions, each with a score of 0-3 (none: 0; a few days: 1; more than half of the time: 2; almost every day: 3), with a total score of 0-27.

Secondary Outcome Measures

Change in the MOS item short form health survey (SF-36)

The SF-36 scale evaluates the quality of healthy life into 8 dimensions, which are divided into two categories: physical health and mental health, namely physical function (PF), role physical (RP), body pain (BP), general health (GH), vitality (VT), social function (SF), role emotional (RE), mental health (MH).

Temperature change of relevant sites

NEC R450 Infrared thermography will be used to record baseline temperature and the temperature change of relevant sites. The average temperature value of relevant sites in the six infrared thermograms is its base temperature.

Pain sensitivity change of relevant sites

A pressure pain threshold gauge will be used to measure the local pain threshold (PT). The probe of the pain gauge will be placed vertically on the relevant test site, and the pressure will be applied slowly and steadily, and when the participant feels pain, the pressure will stop and the reading on the gauge is the PT. The average value of the PT of the same relevant test sites will be calculated as their base PT.

Adverse Events

The adverse events that occurred during the study will be recorded, including symptoms, signs, the time of appearance, duration, degree of severity, treatment measures, and the course of treatment, and their correlation with the treatment will be evaluated. Incidence of adverse events = number of cases of adverse events /total number of cases in the study.

Full Information

NCT ID

NCT05524519

First Posted

August 30, 2022

Last Updated

February 27, 2023

Sponsor

The Third Affiliated hospital of Zhejiang Chinese Medical University

Collaborators

Zhejiang Provincial Tongde Hospital, First People's Hospital of Hangzhou

1. Study Identification

Unique Protocol Identification Number

NCT05524519

Brief Title

Intradermal Acupuncture Based on Changes in Biological Specificity of Acupoints for Major Depressive Disorder

Official Title

Intradermal Acupuncture Based on Changes in Biological Specificity of Acupoints for Major Depressive Disorder: a Prospective, Multicentre, Randomized, Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 1, 2022 (Actual)

Primary Completion Date

December 30, 2025 (Anticipated)

Study Completion Date

December 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The Third Affiliated hospital of Zhejiang Chinese Medical University

Collaborators

Zhejiang Provincial Tongde Hospital, First People's Hospital of Hangzhou

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

Acupoints are the stimulus points and reactive points for acupuncture to treat diseases. Therefore, this study is designed to detect the pain threshold and temperature of biological specificities of acupoints in healthy control (HC) participants and major depressive disorder (MDD) participants by using pressure pain threshold gauge (PTG) and infrared thermography (IRT). Based on the results of the PTG and IRT tests, the potentially superior acupoints for the treatment of MDD will be selected separately. Then, different acupoint groups selected based on different biological specificities tests will be used for clinical treatment to evaluate the clinical efficacy of intradermal acupuncture (IA) for MDD based on changes in the biological specificities of acupoints.

Detailed Description

Part 1: This study will include 30 patients with MDD (MDD group) and 30 HC participants (HC group). PTG and IRT, respectively, will be adopted to assess 2 kinds of biological specificity of MDD-related acupoints: pain sensitivity specificity and thermal specificity. Based on the results of the PTG and IRT tests, the potentially superior acupoints for the treatment of MDD will be selected separately. After statistical analysis of the data from PTG and IRT tests, 4 pressure pain threshold strong response acupoints (PSA) and 4 temperature strong response acupoints (TSA) will be selected, respectively. Part 2: A total of 120 participants with MDD who meet the inclusion criteria will be included in the study. Patients with MDD who met the criteria will be randomly divided 1:1:1:1 into 4 groups: waiting treatment (WT) group, clinical common acupoint (CCA) group, TSA group, and PSA group. All participants received basic therapeutic medication for the use of one or more antidepressants. Dosing and dosage will be adjusted by a specialist. The Patient Health Questionnare-9 (PHQ-9) and the MOS item short form health survey (SF-36) will be used as clinical efficacy outcome indicators, and each group's incidence of adverse effects will be observed. This study will investigate the effectiveness and safety of IA based on changes in the biological specificity of acupoints for MDD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder

Keywords

Major depressive disorder, Intradermal acupuncture, Biological specificity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

WT group

Arm Type

Active Comparator

Arm Description

Arm Title

CCA group

Arm Type

Experimental

Arm Description

This group will include 30 patients with MDD who will be treated with basic treatment and IA. LR3, PC6, SP6, and HT7 will be selected for IA.

Arm Title

TSA group

Arm Type

Experimental

Arm Description

This group will include 30 patients with MDD who will be treated with basic treatment and IA. TSA selected in the first part of the study will be stimulated.

Arm Title

PSA group

Arm Type

Experimental

Arm Description

This group will include 30 patients with MDD who will be treated with basic treatment and IA. PSA selected in the first part of the study will be stimulated.

Intervention Type

Drug

Intervention Name(s)

Basic treatment

Other Intervention Name(s)

Health education and madication

Intervention Description

Health education: Properly explain the causes and precautions of the patient and instruct the patient to rest regularly. In addition, care should be enhanced to avoid accidents. The basic therapeutic drug is the use of one or more antidepressants, such as oral 5-hydroxytryptamine reuptake inhibitors, dual inhibitors of pentraxin and norepinephrine reuptake, noradrenergic and specific pentraxinergic antidepressants, pentraxin receptor balance antagonists, tricyclic antidepressants, etc. If there is significant sleep disturbance, benzodiazepines may be added temporarily. Dosing and dosage will be adjusted by a specialist.

Intervention Type

Procedure

Intervention Name(s)

PSA

Other Intervention Name(s)

Intradermal acupuncture in PSA

Intervention Description

Four PSA selected in the first part of the study will be stimulated. According to the position of the acupoints, choose a needle of φ0.20*1.5m or φ0.20*1.2mm. Press the needle to insert the acupoint vertically and retain it in the skin. After the intervention, the needle will be retained for 72 hours with a day of rest after removal. During needle retention, participants will be instructed to press the acupoints 3-4 times a day for about 1 minute each time, with the amount of stimulation as much as the patient can tolerate, at an interval of about 4 hours. A total of 10 treatment sessions will be performed for 6 weeks.

Intervention Type

Procedure

Intervention Name(s)

TSA

Other Intervention Name(s)

Intradermal acupuncture in TSA

Intervention Description

Four TSA selected in the first part of the study will be stimulated. According to the position of the acupoints, choose a needle of φ0.20*1.5m or φ0.20*1.2mm. Press the needle to insert the acupoint vertically and retain it in the skin. After the intervention, the needle will be retained for 72 hours with a day of rest after removal. During needle retention, participants will be instructed to press the acupoints 3-4 times a day for about 1 minute each time, with the amount of stimulation as much as the patient can tolerate, at an interval of about 4 hours. A total of 10 treatment sessions will be performed for 6 weeks.

Intervention Type

Procedure

Intervention Name(s)

CCA

Other Intervention Name(s)

Intradermal acuppuncture in CCA

Intervention Description

Acupoints: LR3 (Taichong), PC6 (Neiguan), SP6 (Sanyinjiao), and HT7 (Shengmen). PC6 and HT7 will use φ0.20*1.2mm acupuncture needle. LR3 and SP6 will use φ0.20*1.5m acupuncture needles. Press the needle to insert the acupoint vertically and retain it in the skin. After the intervention, the needle will be retained for 72 hours with a day of rest after removal. During needle retention, participants will be instructed to press the acupoints 3-4 times a day for about 1 minute each time, with the amount of stimulation as much as the patient can tolerate, at an interval of about 4 hours. A total of 10 treatment sessions will be performed for 6 weeks.

Primary Outcome Measure Information:

Title

Change in the Patient Health Questionaire-9 Items (PHQ -9)

Description

The PHQ-9 scale has a total of 9 questions, each with a score of 0-3 (none: 0; a few days: 1; more than half of the time: 2; almost every day: 3), with a total score of 0-27.

Time Frame

Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up.

Secondary Outcome Measure Information:

Title

Change in the MOS item short form health survey (SF-36)

Description

Time Frame

Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up.

Title

Temperature change of relevant sites

Description

Time Frame

Baseline, 6 weeks after treatment.

Title

Pain sensitivity change of relevant sites

Description

Time Frame

Baseline, 6 weeks after treatment.

Title

Adverse Events

Description

Time Frame

through study completion (up to 10 weeks).

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Inclusion criteria for HC: HC who could provide a recent depression screening report, and confirm they have not any cardiovascular, respiratory, digestive, urinary, hematological, endocrine, or neurological disease; 18 ≤ age ≤60 years, male or female; Participants have clear consciousness and could communicate with others normally; Participants could understand the full study protocol and have high adherence. Written informed consent is signed by themselves. Inclusion criteria for MDD: Patients should meet the diagnostic criteria of the International Classification of Diseases 10th Edition (ICD-10) diagnostic criteria for MDD; 18 ≤ age ≤60, male or female; Participants have clear consciousness and could communicate with others normally; Participants could understand the full study protocol and have high adherence. Written informed consent is signed by themselves. Exclusion Criteria: Exclusion criteria of HC: Participants with serious primary diseases of cardiovascular diseases, liver diseases, kidney diseases, urinary diseases, and hematological diseases; Participants have a mental illness, alcohol dependence, or a history of drug abuse; Pregnant or lactating participants; Participants with intellectual disabilities who cannot cooperate with the questionnaire survey; Participants with bleeding tendency, skin disease, allergic constitution, and allergic to adhesive tape; The skin at the test site of participants has scars, hyperpigmentation, red and swollen; Participants are participating in other trials. Exclusion criteria for MDD: Participants with serious primary diseases of cardiovascular, respiratory, digestive, urinary, hematological, endocrine, neurological disease, and other serious primary diseases, and the disease cannot be effectively controlled clinically; MDD caused by organic mental disorders, schizophrenia, bipolar disorder, psychoactive substances, and non-addictive substances; Participants with suicidal tendencies; Pregnant or lactating participants; Participants with intellectual disabilities who cannot cooperate with the questionnaire survey; Participants with bleeding tendency, skin disease, allergic constitution, and allergic to adhesive tape; The skin at the test site of participants has scars, hyperpigmentation, red and swollen. IRT is not be performed on female subjects during their menstrual and ovulatory periods; Participants are participating in other trials.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xiaomei Shao, Ph.D

Phone

+8618957130287

shaoxiaomei@zcmu.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Mingqi Tu

Phone

+8615700067213

403712321@qq.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xiaomei Shao, Ph.D

Organizational Affiliation

The Third Affiliated hospital of Zhejiang Chinese Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

the Third affiliated hospital of Zhejiang Chinese Medical university

City

Hangzhou

State/Province

Zhejiang

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xiaomei Shao

Phone

+8618957130287

shaoxiaomei@zcmu.edu.cn

First Name & Middle Initial & Last Name & Degree

Mingqi Tu

Phone

+8615700067213

403712321@qq.com

12. IPD Sharing Statement

Plan to Share IPD

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Intradermal Acupuncture Based on Changes in Biological Specificity of Acupoints for Major Depressive Disorder

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