Clinical trial NCT06560437: Effects of the Manual Therapy on Brain Function in Young Chronic Neck Pain Patients
Official title: Effects of the Chinese Jingjin Manual Therapy on Brain Function in Young Cervical Spondylosis Patients With Chronic Neck Pain: an fMRI Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Lead sponsor: The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2024-08-19
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Amplitude of low-frequency fluctuation value
timeFrame: 5 weeks
measure: Tenderness threshold
timeFrame: 5 weeks
measure: Northwick Park Questionnaire
timeFrame: 5 weeks
measure: Hospital Anxiety and Depression Scale
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hefei
country: China
facility: Wendi Zhang
state: Anhui
Study officials:
affiliation: Anhui University of Chinese Medicine
name: Wendi Zhang
role: PRINCIPAL_INVESTIGATOR
References: