Acupoint Thermal Radiation Characteristics in Adolescents with MDD

Acupoint Thermal Radiation Characteristics in Adolescents with Major Depressive Disorder and Establishment of Diagnostic Model

Modern studies have confirmed that skin temperature changes at acupoints when the body is under pathological conditions. This suggests that changes in the thermal radiation characteristics of acupoints can objectively respond to the symptoms of a disease. In this study, the investigators first evaluated reproducibility of acupoint temperature measurement by IRT. Secondly, the investigators explored the thermal radiation characteristics of MDD-related acupoints, built the diagnostic model for adolescent depression severity and the diagnostic model for MDD in adolescents based on acupoint temperature. Our research findings will provide new ideas, methods and visualisations for early screening, auxiliary diagnosis and condition assessment of MDD in adolescents.

Study Overview

• Status: Completed
• Conditions: Major Depression
• Intervention / Treatment: Diagnostic test: Infrared thermography

Detailed Description

A total of 100 subjects were included, 60 adolescent with MDD (MDD group) and 40 healthy controls (HC group). All subjects accepted IRT detection.The random selection of 30 adolescent with MDD allowed the collection of the bilateral same name acupoint temperatures. Intra- and inter-observer reproducibility for the patients were examined in some randomly selected patients by 2 investigators and 2 investigators both made 2 independent measurements in a week. 30 MDD subjects were detected the bilateral same name acupoint temperatures.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • The Third Affiliated hospital of Zhejiang Chinese Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The diagnostic criteria of MDD were based on criteria proposed by the International Classification of Diseases 10th Edition (ICD-10). Healthy control participants were determined by a recent depression screening report for confirming their mental health conditions.

Description

Inclusion Criteria:

Inclusion criteria for the healthy control participants:

• 12years≤ age<18 years;
• SDS score <53;
• Adolescents with normal cognitive function can cooperate with the study;
• Adolescents and guardians agree to the study plan and sign the informed consent form.

Inclusion criteria for the major depression disorder participants:

• 12years≤ age<18 years;
• Self-rating Depression Scale (SDS) score ≥ 53;
• Language, cognition and communication ability are normal;
• Patients and guardians agree to the study plan and sign the informed consent form.

Exclusion Criteria:

Exclusion criteria both for the healthy control participants and major depression disorder participants:

• Severe anxiety, schizophrenia, or other serious mental illnesses;
• There are pigmentation, redness, infection or scarring on the skin at the site of detection;
• Patients with severe systemic diseases and their complications, serious infections, and major diseases of viscera, tissues, and systems;
• Female patients who were pregnant or lactating;
• Female patients who were during, or in proximity (±2 days) to their menstruation or ovulation;
• Patients with a body temperature ≥37.3°C;
• Inability to cooperate during the examination;
• Participating in any other clinical trials.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy Control group; There were 40 healthy control participants in the Healthy Control group.	Diagnostic test: Infrared thermography; A thermograph (NEC InfRec R450, Avio Infrared Technologies Co., Ltd., Tokyo) was used to record thermal images. The infrared camera was fixed on a tripod 1 m away from the subject to ensure that no shaking movements or vibrations occurred during the recording of thermal images. MDD related acupoints on the inner and outer sides of the limbs were detected. Appropriate body position was selected according to the different parts to be detected. Using the automatic interval saving shooting mode, one thermal picture was taken at 10-s intervals, 3 pictures were taken for each subject.
Major Depression Disorder group; There were 60 MDD patients in the MDD group. All MDD adolescents received at least one IRT test. 26 MDD adolescents were detected by 2 investigators and 2 investigators both made 2 independent measurements in a week. 30 MDD subjects were detected the bilateral same name acupoint temperatures.	Diagnostic test: Infrared thermography; A thermograph (NEC InfRec R450, Avio Infrared Technologies Co., Ltd., Tokyo) was used to record thermal images. The infrared camera was fixed on a tripod 1 m away from the subject to ensure that no shaking movements or vibrations occurred during the recording of thermal images. MDD related acupoints on the inner and outer sides of the limbs were detected. Appropriate body position was selected according to the different parts to be detected. Using the automatic interval saving shooting mode, one thermal picture was taken at 10-s intervals, 3 pictures were taken for each subject.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acupoint emperature	Temperature of acupoints was measured by infrared thermography (IRT). IRT was not be performed on female subjects during their menstrual and ovulatory periods.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Self-Rating Depression Scale (SDS) Scores	The standard score is the total of all scores multiplied by 1.25 to the nearest whole number on this scale, which has 20 questions. A standard score below 53 is normal; 53-62 is mild depression; 63-72 is moderate depression; 72 or more is severe depression.	Baseline

Collaborators and Investigators

• Sponsor: Xiaomei Shao
• Collaborators: First People's Hospital of Hangzhou; Zhejiang Provincial Tongde Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2022
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): November 30, 2024

Study Registration Dates

• First Submitted: December 20, 2024
• First Submitted That Met QC Criteria: December 20, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 27, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: adolescent; Major Depression Disorder; acupoint temperature
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Mood Disorders; Depressive Disorder; Depression; Depressive Disorder, Major
• Other Study ID Numbers: 2022ZX010-IRT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No