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

The Third Affiliated hospital of Zhejiang Chinese Medical University160 enrolled

Overview

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.

Part 1: This study will include 50 patients with MDD (MDD group) and 50 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. This part of the trial began on January 10, 2022, and its registration number is NCT06114342. Part 2: A total of 160 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: wait-listed treatment (WL) 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 Questionnaire-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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

Interventions

Basic treatmentDRUG

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.

PSAPROCEDURE

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.

TSAPROCEDURE

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.

CCAPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

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).

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

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.

Time frame: Baseline, 6 weeks after treatment.

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.

Time frame: Baseline, 6 weeks after treatment.

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.

Time frame: through study completion (up to 10 weeks).