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临床试验/NCT06560437
NCT06560437已完成不适用

Effects of the Chinese Jingjin Manual Therapy on Brain Function in Young Cervical Spondylosis Patients With Chronic Neck Pain: an fMRI Study

Wendi Zhang1 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2023年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
61
试验地点
1
主要终点
Amplitude of low-frequency fluctuation value

研究概览

简要总结

The goal of this clinical trial is to study the central remodeling mechanism of young chronic neck pain patients based on resting-state functional magnetic resonance, and also to study the central analgesic mechanism of Chinese Jingjin Manual Therapy in treating young chronic neck pain patients. The main question it aims to answer are:

Are there specific differences in functional brain activities between young chronic neck pain patients and healthy volunteers? Are there specific changes in brain network function in young chronic neck pain patients before and after Chinese Jingjin Manual Therapy?

Participants will:

The patients in the neck pain group will receive Chinese Jingjin Manual Therapy three times a week for five consecutive weeks.

Before and after the Chinese Jingjin Manual Therapy, patients in the neck pain group were assessed by pressure pain threshold, Northwick Park Questionnaire, and Hospital Anxiety and Depression Scale.

In addition, resting-state functional magnetic resonance data will be collected from the neck pain group and the healthy control group.

详细描述

Chronic neck pain (CNP) is a prevalent condition of the musculoskeletal system that seriously impacts patients' quality of life. The safety and efficacy of Chinese Jingjin manual therapy, a characteristic of Chinese medicine rehabilitation therapy, have been widely recognized. Its mechanism of action is believed to be associated with the functional modulation of brain region networks.Based on the resting-state functional magnetic resonance imaging (fMRI) amplitude of low-frequency fluctuation (ALFF) technique, to observe the differences in spontaneous activity of brain regions between young CNP patients and healthy people. Additionally, the study aims to investigate the changes in brain network function prior to and following the administration of Chinese Jingjin manual therapy.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 44 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Compliance with the diagnostic basis of cervical spondylosis in the Expert Consensus on Typology, Diagnosis, and Nonsurgical Treatment of Cervical Spondylosis issued by China in 2018 and the Diagnostic Efficacy Criteria for Chinese Medicine issued by State Administration of Traditional Chinese Medicine in
  • •Neck pain is the main symptom lasting over 12 weeks. Between the ages of 18 and 44 and be right-handed. Had not received treatment for neck pain within the past month. Voluntary participation in the study, ability to complete the entire treatment program, and signing the informed consent form.

排除标准

  • •The condition was in the acute phase stage (within two weeks of onset). Neck pain is caused by other diseases such as fracture, dislocation, and infection.
  • •Severe heart, liver, kidney, and other vital organ diseases or cognitive impairment.
  • •Pregnant or lactating women, severe osteoporosis. Metal foreign bodies in the body or other contraindications to fMRI examination.

研究组 & 干预措施

the HC groups

No Intervention

The healthy control group without intervention

the CNP group

Experimental

The CNP group received Chinese Jingjin manual therapy which is divided into three major parts: fascia manipulation, bone setting manipulation, and finishing techniques. The operation takes about 30 minutes, and there is one treatment every other day, three treatments per week, and five consecutive weeks of treatment.

干预措施: Chinese Jingjin Manual Therapy (Other)

结局指标

主要结局

Amplitude of low-frequency fluctuation value

时间窗: 5 weeks

The amplitude of low-frequency fluctuation as a measure of the intensity of spontaneous activity in resting brain regions.

Hospital Anxiety and Depression Scale

时间窗: 5 weeks

The HADS scale can simultaneously assess the anxiety and depression status of CNP patients. The lowest score is 0 and the highest score is 52. The higher the score, the more severe the patient's emotional problems of anxiety and depression.

Northwick Park Questionnaire

时间窗: 5 weeks

The NPQ is a commonly used scale to assess functional impairment in patients with CNP. The lowest score is 0 and the highest score is 36. Higher scores indicate more severe neck dysfunction in the patient.

Tenderness threshold

时间窗: 5 weeks

The tenderness threshold a test of the maximum pain threshold that the patient can tolerate

次要结局

未报告次要终点

研究者

发起方
Wendi Zhang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Wendi Zhang

Chinese Medicine Sinew Injury Clinic Doctor

The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

研究点 (1)

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