Effect of Cervical Multifidus Muscle Area on Interlaminar Epidural Steroid Injection Outcomes

NCT05960487 | Unknown

• 1 other identifier: 09.2020.1203
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Cervical radiculopathy is one of the most important causes of chronic neck pain. Cervical epidural steroid injections including interlaminar approach are frequently used for treatment option in patients that more conservative modalities are ineffective. Paraspinal muscles have an important role in supporting neck movements and providing stability of the cervical spine. The multifidus muscle, located in the deepest part of the neck extensor muscle group, has become the muscle that is frequently emphasized in spinal pain in recent years. In the literature, it has been shown that the multifidus muscle on the affected side is atrophied in patients with cervical radiculopathy. Although many factors are known to be effective on the outcomes of cervical interlaminar epidural injection, there are limited data on the effect of the multifidus muscle area. In this retrospective study, it was planned to investigate the effect of the multifidus muscle area on the results of cervical interlaminar epidural steroid injection.

Conditions

Cervical Radiculopathy

Outcome Measures

Primary Outcomes (1)

• Cervical multifidus muscle area

  Multifidus muscle measurement will be performed at 3 levels (C4-C5, C5-C6, C6-C7) in the MR imaging obtained from the medical records of the participants in both groups and the values will be compared with each other. Difference between muscle areas will be evaluated for statistical significance.

  Through study completion, an average of 2 weeks

Study Arms (2)

The patients with a significant decrease in pain severity

Evaluation will be done separately in the 3rd week and 3rd month follow-up periods of the cervical epidural steroid injection. Numerical rating scale (NRS) will be used to evaluate pain severity. A reduction of at least 50 percent in the NRS score will be considered significant.

Other: Cervical multifidus muscle area measurement at 3 levels (C4-C5, C5-C6, C6-C7)

Patients without significant decrease in pain severity

Evaluation will be done separately in the 3rd week and 3rd month follow-up periods of the cervical epidural steroid injection. Numerical rating scale (NRS) will be used to evaluate pain severity. A reduction of at least 50 percent in the NRS score will be considered significant.

Other: Cervical multifidus muscle area measurement at 3 levels (C4-C5, C5-C6, C6-C7)

Interventions

Cervical multifidus muscle area measurement at 3 levels (C4-C5, C5-C6, C6-C7) OTHER

Cervical multifidus muscle area measurement will be performed from both the side affected by radiculopathy and the unaffected side using the magnetic resonance (MR) imaging. Measurements will be made by two researchers, independent of each other.

Patients without significant decrease in pain severity; The patients with a significant decrease in pain severity

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who have cervical disc herniation at the C5-C6 level and have radicular pain complaints for at least 3 months will be included in the study. Cervical interlaminar epidural steroid injection was applied to the patients and their follow-ups at the 3rd week and 3rd month should have been recorded completely.

You may qualify if:

• Patients with unilateral radicular pain due to cervical disc herniation for at least 3 months
• Patients with disc herniation level C5-C6
• Patients who are unresponsive to other conservative treatments and who have undergone cervical interlaminar epidural steroid injection

You may not qualify if:

• Patients with incomplete medical records (absence of MR imaging, incomplete data of 3rd week and 3rd month follow-up periods after cervical interlaminar epidural steroid injection)

Sponsors & Collaborators

• Marmara University: lead

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Gunay Yolcu, M.D.

  Marmara University

  PRINCIPAL INVESTIGATOR

• Osman Hakan Gunduz, Prof.

  Marmara University

  STUDY CHAIR

Central Study Contacts

Savas Sencan, M.D.

CONTACT

+902166254545; savas-44@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2023
• First Posted: July 25, 2023
• Study Start: July 20, 2023
• Primary Completion: August 1, 2023
• Study Completion: August 7, 2023
• Last Updated: July 25, 2023

Record last verified: 2023-07