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NCT Number: NCT06560437

Effects of the Manual Therapy on Brain Function in Young Chronic Neck Pain Patients

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.

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Key information

Conditions

Neck Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–44 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wendi Zhang

Hefei, Anhui, 230012, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 2018.

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.

Exclusion criteria

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.

Treatment and study plan

Chinese Jingjin Manual Therapy

Other

Chinese Jingjin therapy is a form of manual therapy that utilizes the principles of Chinese Jingjin Theory (also known as Chinese Sinew Channel Theory) to alleviate nodular lesions in sinew channels caused by Jingjin injuries and to realign skeletal joints. Chinese Jingjin manual therapy 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.

Other names: Chinese Sinew Manual Therapy

Primary outcomes

  1. Amplitude of low-frequency fluctuation value

    Time frame: 5 weeks

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

  2. Tenderness threshold

    Time frame: 5 weeks

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

  3. Northwick Park Questionnaire

    Time frame: 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.

  4. Hospital Anxiety and Depression Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Wendi Zhang

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 19, 2024
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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