Neck PainNCT06560437
Effects of the Manual Therapy on Brain Function in Young Chronic Neck Pain Patients
A study testing Chinese Jingjin Manual Therapy in people with Neck Pain, run by Wendi Zhang at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Neck Pain
- What is being tested?
- Chinese Jingjin Manual Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2023to 14 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of the Chinese Jingjin Manual Therapy on Brain Function in Young Cervical Spondylosis Patients With Chronic Neck Pain: an fMRI Study
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?
Read more
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.
Read the 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.
- Conditions
- Neck Pain
- Being tested
- Chinese Jingjin Manual Therapy
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese Jingjin Manual TherapyOther
Also called Chinese Sinew 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Chinese Jingjin Manual Therapy |
| the HC groups | No intervention | The healthy control group without intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 weeks
Tenderness threshold
The tenderness threshold a test of the maximum pain threshold that the patient can tolerate
Measured: 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.
Measured: 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.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start1 Apr 2023
- Primary completion1 Mar 2024
- Study completion14 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wendi Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wendi Zhang, The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
- Investigators
- Wendi Zhang, Principal investigator, Anhui University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06560437
- Sponsor's protocol ID
- 2023AH-17
- Status last verified
- Aug 2024
- First submitted
- 14 Aug 2024
- Last updated
- 19 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There are plans to make individual participant data collected in this study such as study protocols and study reports available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Chinese Jingjin Manual Therapy on Brain Function in Young Cervical Spondylosis Patients With Chronic Neck Pain: an fMRI Study
- ClinicalTrials.gov ID
- NCT06560437
- Acronym / sponsor ID
- 2023AH-17
- Conditions
- Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Wendi ZhangUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 14 Aug 2024 (actual)
- First posted
- 19 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the CNP group | Experimental | Other: Chinese Jingjin Manual TherapyThe 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. |
| the HC groups | No intervention | –The healthy control group without intervention |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chinese Jingjin Manual TherapyAlso: Chinese Sinew Manual TherapyChinese 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 | the CNP group |
Primary outcome
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.
Tenderness threshold
Time frame: 5 weeks
The tenderness threshold a test of the maximum pain threshold that the patient can tolerate
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Individual participant dataSharing planned: Yes. There are plans to make individual participant data collected in this study such as study protocols and study reports available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wendi Zhang principal investigator
Anhui University of Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chinese Jingjin Manual Therapy in people with Neck Pain, run by Wendi Zhang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amplitude of low-frequency fluctuation value (time frame: 5 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024.