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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cervical Radiculopathy
• Intervention / Treatment: Other: Cervical multifidus muscle area measurement at 3 levels (C4-C5, C5-C6, C6-C7)

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Savas Sencan, M.D.; Phone Number: 1611 +902166254545; Email: savas-44@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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); 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; 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Marmara University
• Investigators: Principal Investigator: Gunay Yolcu, M.D., Marmara University; Study Chair: Osman Hakan Gunduz, Prof., Marmara University

Study record dates

Study Major Dates

• Study Start (Estimated): July 20, 2023
• Primary Completion (Estimated): August 1, 2023
• Study Completion (Estimated): August 7, 2023

Study Registration Dates

• First Submitted: July 9, 2023
• First Submitted That Met QC Criteria: July 14, 2023
• First Posted (Actual): July 25, 2023

Study Record Updates

• Last Update Posted (Actual): July 25, 2023
• Last Update Submitted That Met QC Criteria: July 14, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Radiculopathy
• Other Study ID Numbers: 09.2020.1203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No