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

Cervical Radiculopathy Clinical Trial

Official title:

Can Multifidus Muscle Area Affect Cervical Interlaminar Epidural Steroid Injection Outcomes?

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05960487
• Other study ID #: 09.2020.1203
• Status: Not yet recruiting
• Start date: July 20, 2023
• Est. completion date: August 7, 2023

Study information

• Verified date: July 2023
• Source: Marmara University
• Contact: Savas Sencan, M.D.
• Phone: +902166254545
• Email: savas-44[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: August 7, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Cervical Radiculopathy
• Radiculopathy

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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