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NCT Number: NCT06217029

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

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.

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Key information

Conditions

Neck Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.)

Exclusion criteria

  • 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.

Treatment and study plan

physiotherapy and maxillary traction

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

Other names: massage therapy

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. T2* value alteration before and after 12 months treatment

    Time frame: 0, 12 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dan Li, M.D.

CONTACT

[email protected]

+8613324598146

Yuan Wang, M.D.

CONTACT

[email protected]

+8613324598144

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University

Other

Registry information

Official study title

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

Acronym: MRI-CervPain

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jan 22, 2024
Registry last updated
Feb 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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