Skip to content

Magnetic Resonance Imaging Study on Young and Middle-aged Patients With Cervical Spondylotic Pain

Applied Research on Young and Middle-aged Patients With Cervical Spondylotic Pain Using T2-mapping, T1ρ and Diffusion Kurtosis Imaging

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06217029
Acronym
MRI-CervPain
Enrollment
80
Registered
2024-01-22
Start date
2024-01-06
Completion date
2027-12-31
Last updated
2024-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neck Pain

Keywords

neck pain, young adults, T2-mapping, T1ρ, DKI

Brief 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. 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.

Interventions

OTHERphysiotherapy and maxillary traction

1. 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

Sponsors

First Affiliated Hospital Xi'an Jiaotong University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

1. Neck and shoulder pain, with or without upper limb pain and numbness; 2. Disease duration longer than 2 months 3. Visual analogue score (VAS) ≥ 3 4. Cervical MRI showing cervical disc degeneration, bulge, protrusion, etc. 5. Patients will undergo non-surgical treatment (maxillary occipital traction, massage, etc.)

Exclusion criteria

1. Severe trauma and surgery in neck and shoulder region. 2. 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. 3. Cervical MRI revealed organic lesions such as inflammation of the spinal cord, tumors, syringomyelia, etc. 4. Chronic pain in other regions.

Design outcomes

Primary

MeasureTime frameDescription
T1ρ alteration before and after 12 months treatment0, 12 monthsT1ρ 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 treatment0, 12 monthsDiffusion 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.

Secondary

MeasureTime frameDescription
T2* value alteration before and after 12 months treatment0, 12 monthsT2\* 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.

Countries

China

Contacts

Primary ContactYuan Wang, M.D.
wangyuan8003@126.com+8613324598144
Backup ContactDan Li, M.D.
youyouyu1010@163.com+8613324598146

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026