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

Neck Pain Clinical Trial

— MRI-CervPain  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06217029
• Other study ID #: XJTU1AF-CRF-2023-030
• Status: Recruiting
• Start date: January 6, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: February 2024
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Yuan Wang, M.D.
• Phone: +8613324598144
• Email: wangyuan8003[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neck Pain

Intervention

Other:
• physiotherapy and maxillary traction
Mobility exercises Ultrasound or electric stimulation Application of equipment, such as braces, slings and taping Registered massage therapy Trigger point and myofascial release

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

References & Publications (4)

Chen 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 — View Citation

Chen 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 — View Citation

Leonova 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. — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	T1? alteration before and after 12 months treatment	T1? 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 T1? and glycosaminoglycan content, suggesting that T1? may be sensitive to early biochemical changes in disc degeneration. T1? will be measured in the nucleus pulposus, anterior and posterior annulus fibrosus of the cervical intervertebral disc.	0, 12 months
Primary	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.	0, 12 months
Secondary	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.	0, 12 months