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

Not yet recruiting

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

• Registration Number: NCT05960487
• Lead Sponsor: Marmara University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-07-09
• Study First Submitted QC: 2023-07-14
• Last Update Submitted: 2023-07-14
• Study Start: 2023-07-20
• Study First Posted: 2023-07-25
• Last Update Posted: 2023-07-25
• Primary Completion: 2023-08-01
• Study Completion: 2023-08-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients without significant decrease in pain severity	Cervical multifidus muscle area measurement at 3 levels (C4-C5, C5-C6, C6-C7)	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.
The patients with a significant decrease in pain severity	Cervical multifidus muscle area measurement at 3 levels (C4-C5, C5-C6, C6-C7)	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.

Primary Outcome Measures

Name	Time	Method
Cervical multifidus muscle area	Through study completion, an average of 2 weeks	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.