Study on Brain Structure and Function of Pain-related Emotion Disorder

• Conditions: Depressive Symptoms; Anxiety State; Osteoarthritis, Knee
• Interventions: Diagnostic Test: Functional magnetic resonance examination

• Registration Number: NCT03912610
• Lead Sponsor: Zhoujie

Brief Summary

By the method of multi-mode Magnetic Resonance Imaging, 5 patients with knee osteoarthritis are selected in this trial to observe the possible differences in the brain structure and function from the 5 healthy volunteers.

Detailed Description

In this study, 5 patients with knee osteoarthritis and 5 healthy volunteers were selected. The degree of pain is evaluated via visual analogue pain scale (VAS). The emotional state is evaluated by Hamilton anxiety scale (HAMA) or Hamilton depression scale (HAMD). The patients and healthy volunteers who meet the include criteria are include in the research. Then the spontaneous brain electrical activity is collected by multimodal brain magnetic resonance imaging technology. The spontaneous brain electrical activity is analyzed to find the differences between knee osteoarthritis patients and healthy volunteers. Further analysis of resting brain functional connectivity and information exchange changes in multifunctional areas, in order to elaborate the central mechanism of pain and emotion modulation.

Study Timeline

• Status Verified: 2019-04
• Study First Submitted: 2019-04-04
• Study First Submitted QC: 2019-04-10
• Last Update Submitted: 2019-04-10
• Study First Posted: 2019-04-11
• Last Update Posted: 2019-04-12
• Study Start: 2019-05
• Primary Completion: 2022-04
• Study Completion: 2022-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

The experimental group was selected as:

• Meet the above diagnostic criteria.
• VAS scale score > 4 points.
• HAMA score > 14 or HAMD score > 17 points.
• Agree to participate in the survey and submit an informed consent form.

The control group was selected as:

• Healthy volunteers who exclude knee osteoarthritis.
• VAS scale score ≤ 4 points.
• HAMA score ≤14 or HAMD score ≤ 17 points.
• Agree to participate in the survey and submit an informed consent form

Exclusion Criteria

• Rheumatoid arthritis, psoriatic arthritis, gouty arthritis, bone erosion, bone tuberculosis, bone tumor patients.
• Clear diagnosis of traumatic meniscus, cruciate ligament, collateral ligament injury history and patients with history of knee trauma in the past six months.
• Have a heavier heart, brain and other medical conditions and poor overall health.
• In pregnancy, pregnancy or lactation.
• Taking antidepressant and anxiety drugs.
• Participated in other clinical studies within 2 months prior to the start of the study.
• The patient or his licensor is unwilling to sign a written informed consent or is unwilling to follow the research protocol.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Health control group	Functional magnetic resonance examination	5 health volunteer are included in the group. Each volunteer will take the functional magnetic resonance examination one to collect the data.
Knee osteoarthritis group	Functional magnetic resonance examination	5 patients of knee osteoarthritis accompanied with depression or anxiety are included in the group. Each volunteer will take the functional magnetic resonance examination one to collect the data.

Primary Outcome Measures

Name	Time	Method
blood-oxygen-level dependent (BOLD) signal	the data will be collected the second day when entering group	BOLD is used in functional magnetic resonance imaging (fMRI) to observe different areas of the brain or other organs, which are found to be active at any given time. The hemoglobin content, blood flow volume and oxygen consumption of special brain regions will be observed via BOLD. Oxyhemoglobin ratio is used in this measurement.