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

NCT06560437 | Completed

• 1 other identifier: 2023AH-17
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Neck Pain

Outcome Measures

Primary Outcomes (4)

• Amplitude of low-frequency fluctuation value

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

  5 weeks

• Tenderness threshold

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

  5 weeks

• Northwick Park Questionnaire

  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.

  5 weeks

• Hospital Anxiety and Depression Scale

  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.

  5 weeks

Study Arms (2)

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.

Other: Chinese Jingjin Manual Therapy

the HC groups

NO INTERVENTION

The healthy control group without intervention

Interventions

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.

Also known as: Chinese Sinew Manual Therapy

the CNP group

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wendi Zhang: lead

Study Sites (1)

Wendi Zhang

Hefei, Anhui, 230012, China

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Wendi Zhang

  Anhui University of Chinese Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chinese Medicine Sinew Injury Clinic Doctor

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 19, 2024
• Study Start: April 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: August 14, 2024
• Last Updated: August 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: starting 6 months after publication
• Access Criteria: Review request information may be submitted to the principal investigator if researching content in similar fields will be shared.

Locations

CN (1)