Intradermal Acupuncture Based on Changes in Biological Specificity of Acupoints for Major Depressive Disorder: a Prospective, Multicentre, Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Change in the Patient Health Questionaire-9 Items (PHQ -9)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
WL group
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.
干预措施: Basic treatment (Drug)
CCA group
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.
干预措施: Basic treatment (Drug)
CCA group
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.
干预措施: CCA (Procedure)
TSA group
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.
干预措施: Basic treatment (Drug)
TSA group
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.
干预措施: TSA (Procedure)
PSA group
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.
干预措施: Basic treatment (Drug)
PSA group
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.
干预措施: PSA (Procedure)
结局指标
主要结局
Change in the Patient Health Questionaire-9 Items (PHQ -9)
时间窗: Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up.
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.
次要结局
- Pain sensitivity change of relevant sites(Baseline, 6 weeks after treatment.)
- 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.)
- Adverse Events(through study completion (up to 10 weeks).)
研究者
Xiaomei Shao
Prof
The Third Affiliated hospital of Zhejiang Chinese Medical University