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

NCT05524519 | Completed

• 1 other identifier: 2022ZX010-BIA
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

Major depressive disorder; Intradermal acupuncture; Biological specificity

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (4)

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

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

• Temperature change of relevant sites

  Baseline, 6 weeks after treatment.

• Pain sensitivity change of relevant sites

  Baseline, 6 weeks after treatment.

• Adverse Events

  through study completion (up to 10 weeks).

Study Arms (4)

WL group

ACTIVE COMPARATOR

This group will include 40 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.

Drug: Basic treatment

CCA group

EXPERIMENTAL

This group will include 40 patients with MDD who will be treated with basic treatment and IA. LR3, PC6, SP6, and HT7 will be selected for IA.

Drug: Basic treatment; Procedure: CCA

TSA group

EXPERIMENTAL

This group will include 40 patients with MDD who will be treated with basic treatment and IA. TSA selected in the first part of the study will be stimulated.

Drug: Basic treatment; Procedure: TSA

PSA group

EXPERIMENTAL

This group will include 40 patients with MDD who will be treated with basic treatment and IA. PSA selected in the first part of the study will be stimulated.

Drug: Basic treatment; Procedure: PSA

Interventions

Basic treatment DRUG

1. 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. 2. 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.

Also known as: Health education and medication

CCA group; PSA group; TSA group; WL group

PSA PROCEDURE

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.

Also known as: Intradermal acupuncture in PSA

PSA group

TSA PROCEDURE

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.

Also known as: Intradermal acupuncture in TSA

TSA group

CCA PROCEDURE

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.

Also known as: Intradermal acupuncture in CCA

CCA group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• HC who could provide a recent depression screening report, and confirm they have not any cardiovascular, respiratory, digestive, urinary, hematological, endocrine, or neurological disease;
• ≤ 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.
• Patients should meet the diagnostic criteria of the International Classification of Diseases 10th Edition (ICD-10) diagnostic criteria for MDD;
• ≤ 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• The Third Affiliated hospital of Zhejiang Chinese Medical University: lead
• Zhejiang Provincial Tongde Hospital: collaborator
• First People's Hospital of Hangzhou: collaborator

Study Sites (1)

the Third affiliated hospital of Zhejiang Chinese Medical university

Hangzhou, Zhejiang, China

Location

Related Publications (1)

• Tu M, Wu X, Qu S, Jin J, Chen N, Xiong S, Pei S, Li X, Shi Y, Hu H, Li X, Fang J, Shao X. The effective on intradermal acupuncture based on changes in biological specificity of acupoints for major depressive disorder: study protocol of a prospective, multicenter, randomized, controlled trial. Front Psychiatry. 2023 Jun 9;14:1183127. doi: 10.3389/fpsyt.2023.1183127. eCollection 2023.

  PMID: 37441145 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Dosage Forms; theasinensin A

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Officials

• Xiaomei Shao, Ph.D

  The Third Affiliated hospital of Zhejiang Chinese Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: September 1, 2022
• Study Start: November 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)