Clinical trial NCT06217029: Magnetic Resonance Imaging Study on Young and Middle-aged Patients With Cervical Spondylotic Pain
Official title: Applied Research on Young and Middle-aged Patients With Cervical Spondylotic Pain Using T2-mapping, T1ρ and Diffusion Kurtosis Imaging
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neck Pain
Keywords: neck pain
young adults
T2-mapping
T1ρ
DKI
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Young adults patients with neck and shoulder pain, who will undergo cervical spine MRI and non-surgical treatment

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.

Eligibility criteria: 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.

Primary outcomes:
measure: T1ρ alteration before and after 12 months treatment
timeFrame: 0, 12 months
measure: Alterations of MK value before and after 12 months treatment
timeFrame: 0, 12 months
Secondary outcomes:
measure: T2* value alteration before and after 12 months treatment
timeFrame: 0, 12 months
Other outcomes:
Locations:
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Ming Zhang, M.D.
role: STUDY_DIRECTOR
References:
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.
citation: 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 asymptomatic young adults. PLoS One. 2014 Feb 3;9(2):e87856. doi: 10.1371/journal.pone.0087856. eCollection 2014.
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 Feb 18;2018:6843053. doi: 10.1155/2018/6843053. eCollection 2018.
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.