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

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

Interventions

DRUG

Basic treatment

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.

PROCEDURE

PSA

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.

PROCEDURE

TSA

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.

PROCEDURE

CCA

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.

Sponsors & Collaborators

• Zhejiang Provincial Tongde Hospital

  collaborator OTHER

• First People's Hospital of Hangzhou

  collaborator OTHER

• The Third Affiliated hospital of Zhejiang Chinese Medical University

  lead OTHER

Principal Investigators

• Xiaomei Shao, Ph.D · The Third Affiliated hospital of Zhejiang Chinese Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-11-01

Primary Completion

2023-12-31

Completion

2023-12-31

Countries

• China

Study Locations