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

NCT ID: NCT05960487

Last Updated: 2023-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-20

Study Completion Date

2023-08-07

Brief Summary

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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

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Conditions

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Cervical Radiculopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

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

Intervention Type 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

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.

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

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Marmara University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gunay Yolcu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Marmara University

Osman Hakan Gunduz, Prof.

Role: STUDY_CHAIR

Marmara University

Central Contacts

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Savas Sencan, M.D.

Role: CONTACT

+902166254545 ext. 1611

Other Identifiers

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09.2020.1203

Identifier Type: -

Identifier Source: org_study_id

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