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

Xi'an Jiaotong University

Status: Enrolling

Conditions: Neck Pain

Treatments: Other: physiotherapy and maxillary traction

Study type: Observational

Funder types: Other

Identifiers

NCT06217029

XJTU1AF-CRF-2023-030

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

80 participants in 2 patient groups

Effective Group of Cervical Spondylotic Pain

Description:

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,

Treatment:

Other: physiotherapy and maxillary traction

Ineffective Group of Cervical Spondylotic Pain

Description:

The "slight effect + ineffective" group and the recurrent group were classified as the treatment ineffective group

Treatment:

Other: physiotherapy and maxillary traction