Neck PainMRI-CervPainNCT06217029
Magnetic Resonance Imaging Study on Young and Middle-aged Patients With Cervical Spondylotic Pain
An observational study of Neck Pain, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
Cervical and shoulder pain in young adults is commonly caused by intervertebral disc degeneration, bulge or herniation. Disc degeneration includes the synthetic and degradative imbalance of myxoid matrix, degeneration of annulus collagen, and decrease of water content in nucleus pulposus. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- physiotherapy and maxillary traction
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 6 Jan 2024to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Young adults patients with neck and shoulder pain, who will undergo cervical spine MRI and non-surgical treatment
Who may be able to join
- Neck and shoulder pain, with or without upper limb pain and numbness;
- Disease duration longer than 2 months
- Visual analogue score (VAS) ≥ 3
- Cervical MRI showing cervical disc degeneration, bulge, protrusion, etc.
- Patients will undergo non-surgical treatment (maxillary occipital traction, massage, etc.)
Who cannot join
- Severe trauma and surgery in neck and shoulder region.
- X-ray or CT showing the severe cervical spine hyperplasia, infection (suppurative, tuberculous), neoplasm (various primary and secondary tumors), rheumatic (rheumatoid arthritis, ankylosing spondylitis), and nuclei pulposus calcification.
- Cervical MRI revealed organic lesions such as inflammation of the spinal cord, tumors, syringomyelia, etc.
- Chronic pain in other regions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Yuan Wang, M.D., 0086-13324598144, wangyuan8003@126.com
Dan Li, M.D., 0086-13324598146, youyouyu1010@163.com
About this study
Official title: Applied Research on Young and Middle-aged Patients With Cervical Spondylotic Pain Using T2-mapping, T1ρ and Diffusion Kurtosis Imaging
Cervical and shoulder pain in young adults is commonly caused by intervertebral disc degeneration, bulge or herniation. Disc degeneration includes the synthetic and degradative imbalance of myxoid matrix, degeneration of annulus collagen, and decrease of water content in nucleus pulposus. A few patients with cervical degeneration had moderate to severe pain, but there are no obvious abnormalities in the shape and signal of the disc with routine MRI, which may be related to the early discal degeneration. In most cases, the pain could be relieved by non-surgical treatment due to mild decreased proteoglycan and slight abnormality of water diffusion, but these changes cannot be clearly demonstrated by routine MRI. Therefore, it is necessary to rely on sensitive MRI techniques to reflect the abnormal microstructure in the nucleus pulposus and annulus fibrosus, so as to assist the early detection of the main reason in patients with neck and shoulder pain and the evaluation of the efficacy of treatment.
Read the detailed description
This is an observational, longitudinal, and single-center study. Confirmed patients with cervical and shoulder pain will complete several clinical and imaging programs before and after 3 and 12 months of non-surgical treatment for exploring the main reason of the symptom and the imaging predictors of treatment effect in the disease. The collected materials are listed below: (1) 3 times cervical MRI scans, including T2-mapping, T1ρ and DKI sequences, (2) visual analog scale (for pain assessment) and disease duration. Then the T2 value, T1ρ, and DKI derived parameters will be measured in the nucleus pulposus and annulus fibrosus.
- Conditions
- Neck Pain
- Being tested
- physiotherapy and maxillary traction
- Keywords
- neck pain, young adults, T2-mapping, T1ρ, DKI
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physiotherapy and maxillary tractionOther
Also called massage therapy
- Mobility exercises
- Ultrasound or electric stimulation
- Application of equipment, such as braces, slings and taping
- Registered massage therapy
- Trigger point and myofascial release
| Study group | Role | What they receive |
|---|---|---|
| Effective Group of Cervical Spondylotic Pain | VAS reduction rate is used to evaluate clinical efficacy. The reduction rate = (baseline value - end value)/baseline value. The clinical efficacy is divided into four levels: cured, significant effect, slight effect, ineffective or recurrent. cured: reduction rate ≥ 75%; significant effect: 50% ≤ reduction rate < 75%; slight effect: 25% ≤ reduction rate < 50%; ineffective: reduction rate < 25%. The "cured + significant effect" group was classified as the treatment effective group, Receives: Other: physiotherapy and maxillary traction | |
| Ineffective Group of Cervical Spondylotic Pain | The "slight effect + ineffective" group and the recurrent group were classified as the treatment ineffective group Receives: Other: physiotherapy and maxillary traction |
What is being measured
The primary outcome is the main question the study is designed to answer.
T1ρ alteration before and after 12 months treatment
T1ρ imaging, which probes the interaction between water molecules and their macromolecular environment, has the potential to identify early biochemical changes in the intervertebral disc. There are correlations between T1ρ and glycosaminoglycan content, suggesting that T1ρ may be sensitive to early biochemical changes in disc degeneration. T1ρ will be measured in the nucleus pulposus, anterior and posterior annulus fibrosus of the cervical intervertebral disc.
Measured: 0, 12 months
Alterations of MK value before and after 12 months treatment
Diffusion MRI techniques are noninvasive and quantitative techniques that can assess intervertebral disc degeneration by offering information about the properties of the water molecular diffusion process in intervertebral disc. In vivo tissues, the diffusion of water molecules has been hindered and restricted by complex microstructures, leading to a non-Gaussian probability distribution function. As a non-Gaussian model, diffusion kurtosis imaging (DKI) has a higher potential to characterize both molecular water diffusion and the complexity of tissue microstructures. DKI technique can provide several quantitative parameters, and the most important one is mean kurtosis (MK). MK value will be measured in the nucleus pulposus, anterior and posterior annulus fibrosus of the cervical intervertebral disc.
Measured: 0, 12 months
Secondary outcomes (1)
T2* value alteration before and after 12 months treatment
T2* mapping is sensitive to collagen fiber network. There is close correlation between T2* mapping and Pfirrmann grade, where a decrease in T2* value is significantly associated with the aggravation of intervertebral disc degeneration. Pathologically, T2* value is regarded as a robust biomarker at an earlier stage of disc degeneration. T2* value will be measured in the nucleus pulposus, anterior and posterior annulus fibrosus of the cervical intervertebral disc.
Measured: 0, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start6 Jan 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ming Zhang, M.D., Study director, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06217029
- Sponsor's protocol ID
- XJTU1AF-CRF-2023-030
- Acronym
- MRI-CervPain
- Status last verified
- Feb 2024
- First submitted
- 8 Jan 2024
- Last updated
- 26 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhuang L, Wang L, Xu D, Wang Z, Liang R. Association between excessive smartphone use and cervical disc degeneration in young patients suffering from chronic neck pain. J Orthop Sci. 2021 Jan;26(1):110-115. doi: 10.1016/j.jos.2020.02.009. Epub 2020 Mar 20.
PubMed 32205018Chen C, Huang M, Han Z, Shao L, Xie Y, Wu J, Zhang Y, Xin H, Ren A, Guo Y, Wang D, He Q, Ruan D. Quantitative T2 magnetic resonance imaging compared to morphological grading of the early cervical intervertebral disc degeneration: an evaluation approach in asymptomatic young adults. PLoS One. 2014 Feb 3;9(2):e87856. doi: 10.1371/journal.pone.0087856. eCollection 2014.
PubMed 24498384Chen P, Wu C, Huang M, Jin G, Shi Q, Han Z, Chen C. Apparent Diffusion Coefficient of Diffusion-Weighted Imaging in Evaluation of Cervical Intervertebral Disc Degeneration: An Observational Study with 3.0 T Magnetic Resonance Imaging. Biomed Res Int. 2018 Feb 18;2018:6843053. doi: 10.1155/2018/6843053. eCollection 2018.
PubMed 29670903Leonova O, Baykov E, Sanginov A, Krutko A. Cervical Disc Degeneration and Vertebral Endplate Defects After the Fused Operation. Spine (Phila Pa 1976). 2021 Sep 15;46(18):1234-1240. doi: 10.1097/BRS.0000000000004007.
PubMed 33595261
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applied Research on Young and Middle-aged Patients With Cervical Spondylotic Pain Using T2-mapping, T1ρ and Diffusion Kurtosis Imaging
- ClinicalTrials.gov ID
- NCT06217029
- Acronym / sponsor ID
- MRI-CervPain / XJTU1AF-CRF-2023-030
- Conditions
- Neck Pain
- Keywords
- neck pain, young adults, T2-mapping, T1ρ, DKI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 6 Jan 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 Jan 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.
Cervical and shoulder pain in young adults is commonly caused by intervertebral disc degeneration, bulge or herniation. Disc degeneration includes the synthetic and degradative imbalance of myxoid matrix, degeneration of annulus collagen, and decrease of water content in nucleus pulposus. A few patients with cervical degeneration had moderate to severe pain, but there are no obvious abnormalities in the shape and signal of the disc with routine MRI, which may be related to the early discal degeneration. In most cases, the pain could be relieved by non-surgical treatment due to mild decreased proteoglycan and slight abnormality of water diffusion, but these changes cannot be clearly demonstrated by routine MRI. Therefore, it is necessary to rely on sensitive MRI techniques to reflect the abnormal microstructure in the nucleus pulposus and annulus fibrosus, so as to assist the early detection of the main reason in patients with neck and shoulder pain and the evaluation of the efficacy of treatment.
Detailed description
This is an observational, longitudinal, and single-center study. Confirmed patients with cervical and shoulder pain will complete several clinical and imaging programs before and after 3 and 12 months of non-surgical treatment for exploring the main reason of the symptom and the imaging predictors of treatment effect in the disease. The collected materials are listed below: (1) 3 times cervical MRI scans, including T2-mapping, T1ρ and DKI sequences, (2) visual analog scale (for pain assessment) and disease duration. Then the T2 value, T1ρ, and DKI derived parameters will be measured in the nucleus pulposus and annulus fibrosus.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Effective Group of Cervical Spondylotic Pain | – | Other: physiotherapy and maxillary tractionVAS reduction rate is used to evaluate clinical efficacy. The reduction rate = (baseline value - end value)/baseline value. The clinical efficacy is divided into four levels: cured, significant effect, slight effect, ineffective or recurrent. cured: reduction rate ≥ 75%; significant effect: 50% ≤ reduction rate < 75%; slight effect: 25% ≤ reduction rate < 50%; ineffective: reduction rate < 25%. The "cured + significant effect" group was classified as the treatment effective group, |
| Ineffective Group of Cervical Spondylotic Pain | – | Other: physiotherapy and maxillary tractionThe "slight effect + ineffective" group and the recurrent group were classified as the treatment ineffective group |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Young adults patients with neck and shoulder pain, who will undergo cervical spine MRI and non-surgical treatment
Key inclusion criteria (5 listed)
- Neck and shoulder pain, with or without upper limb pain and numbness;
- Disease duration longer than 2 months
- Visual analogue score (VAS) ≥ 3
- Cervical MRI showing cervical disc degeneration, bulge, protrusion, etc.
- Patients will undergo non-surgical treatment (maxillary occipital traction, massage, etc.)
Key exclusion criteria (4 listed)
- Severe trauma and surgery in neck and shoulder region.
- X-ray or CT showing the severe cervical spine hyperplasia, infection (suppurative, tuberculous), neoplasm (various primary and secondary tumors), rheumatic (rheumatoid arthritis, ankylosing spondylitis), and nuclei pulposus calcification.
- Cervical MRI revealed organic lesions such as inflammation of the spinal cord, tumors, syringomyelia, etc.
- Chronic pain in other regions.
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 |
|---|---|---|
| physiotherapy and maxillary tractionAlso: massage therapy1. Mobility exercises 2. Ultrasound or electric stimulation 3. Application of equipment, such as braces, slings and taping 4. Registered massage therapy 5. Trigger point and myofascial release | Other | Effective Group of Cervical Spondylotic Pain, Ineffective Group of Cervical Spondylotic Pain |
Primary outcome
T1ρ alteration before and after 12 months treatment
Time frame: 0, 12 months
T1ρ imaging, which probes the interaction between water molecules and their macromolecular environment, has the potential to identify early biochemical changes in the intervertebral disc. There are correlations between T1ρ and glycosaminoglycan content, suggesting that T1ρ may be sensitive to early biochemical changes in disc degeneration. T1ρ will be measured in the nucleus pulposus, anterior and posterior annulus fibrosus of the cervical intervertebral disc.
Alterations of MK value before and after 12 months treatment
Time frame: 0, 12 months
Diffusion MRI techniques are noninvasive and quantitative techniques that can assess intervertebral disc degeneration by offering information about the properties of the water molecular diffusion process in intervertebral disc. In vivo tissues, the diffusion of water molecules has been hindered and restricted by complex microstructures, leading to a non-Gaussian probability distribution function. As a non-Gaussian model, diffusion kurtosis imaging (DKI) has a higher potential to characterize both molecular water diffusion and the complexity of tissue microstructures. DKI technique can provide several quantitative parameters, and the most important one is mean kurtosis (MK). MK value will be measured in the nucleus pulposus, anterior and posterior annulus fibrosus of the cervical intervertebral disc.
1 secondary outcome
T2* value alteration before and after 12 months treatment
Time frame: 0, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Results publication: PubMed 32205018Zhuang L, Wang L, Xu D, Wang Z, Liang R. Association between excessive smartphone use and cervical disc degeneration in young patients suffering from chronic neck pain. J Orthop Sci. 2021 Jan;26(1):110-115. doi: 10.1016/j.jos.2020.02.009. Epub 2020 Mar 20.
- Results publication: PubMed 24498384Chen C, Huang M, Han Z, Shao L, Xie Y, Wu J, Zhang Y, Xin H, Ren A, Guo Y, Wang D, He Q, Ruan D. Quantitative T2 magnetic resonance imaging compared to morphological grading of the early cervical intervertebral disc degeneration: an evaluation approach in asymptomatic young adults. PLoS One. 2014 Feb 3;9(2):e87856. doi: 10.1371/journal.pone.0087856. eCollection 2014.
- Results publication: PubMed 29670903Chen P, Wu C, Huang M, Jin G, Shi Q, Han Z, Chen C. Apparent Diffusion Coefficient of Diffusion-Weighted Imaging in Evaluation of Cervical Intervertebral Disc Degeneration: An Observational Study with 3.0 T Magnetic Resonance Imaging. Biomed Res Int. 2018 Feb 18;2018:6843053. doi: 10.1155/2018/6843053. eCollection 2018.
- Results publication: PubMed 33595261Leonova O, Baykov E, Sanginov A, Krutko A. Cervical Disc Degeneration and Vertebral Endplate Defects After the Fused Operation. Spine (Phila Pa 1976). 2021 Sep 15;46(18):1234-1240. doi: 10.1097/BRS.0000000000004007.
- Individual participant dataSharing planned: No
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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.
Ming Zhang, M.D. study director
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neck Pain, run by First Affiliated Hospital Xi'an Jiaotong University 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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 26 Feb 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuan Wang, M.D. (+8613324598144, wangyuan8003@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
T1ρ alteration before and after 12 months treatment (time frame: 0, 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06217029, which also lists 4 linked publications.
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 26 Feb 2024.