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

NCT ID: NCT06560437

Last Updated: 2024-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2024-08-14

Brief Summary

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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

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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.

Conditions

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Neck Pain

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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the CNP group

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.

Group Type EXPERIMENTAL

Chinese Jingjin Manual Therapy

Intervention Type 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.

the HC groups

The healthy control group without intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Chinese Jingjin Manual Therapy

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.

Intervention Type OTHER

Other Intervention Names

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Chinese Sinew Manual Therapy

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

44 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wendi Zhang

OTHER

Sponsor Role lead

Responsible Party

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Wendi Zhang

Chinese Medicine Sinew Injury Clinic Doctor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Wendi Zhang

Role: PRINCIPAL_INVESTIGATOR

Anhui University of Chinese Medicine

Locations

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Wendi Zhang

Hefei, Anhui, China

Site Status

Countries

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China

Other Identifiers

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2023AH-17

Identifier Type: -

Identifier Source: org_study_id

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