Magnetic Resonance Imaging Study on Young and Middle-aged Patients With Cervical Spondylotic Pain (MRI-CervPain)

February 22, 2024 updated by: First Affiliated Hospital Xi'an Jiaotong University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / 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 Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Young adults patients with neck and shoulder pain, who will undergo cervical spine MRI and non-surgical treatment

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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,
Other: physiotherapy 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
Other Names:
  • massage therapy
Ineffective Group of Cervical Spondylotic Pain
The "slight effect + ineffective" group and the recurrent group were classified as the treatment ineffective group
Other: physiotherapy 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
Other Names:
  • massage therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0, 12 months
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.
0, 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Investigators

  • Study Director: Ming Zhang, M.D., First Affiliated Hospital Xi'an Jiaotong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

January 8, 2024

First Submitted That Met QC Criteria

January 18, 2024

First Posted (Actual)

January 22, 2024

Study Record Updates

Last Update Posted (Actual)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJTU1AF-CRF-2023-030

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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