Cervical RadiculopathyNCT05960487
Effect of Cervical Multifidus Muscle Area on Interlaminar Epidural Steroid Injection Outcomes
An observational study of Cervical Radiculopathy, run by Marmara University.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervical Radiculopathy
- What is being tested?
- Cervical multifidus muscle area measurement at 3 levels (C4-C5, C5-C6, C6-C7)
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 20 Jul 2023to 7 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Cervical Radiculopathy
- Being tested
- Cervical multifidus muscle area measurement at 3 levels (C4-C5, C5-C6, C6-C7)
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Cervical multifidus muscle area measurement at 3 levels (C4-C5, C5-C6, C6-C7) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start20 Jul 2023 (estimated)
- Primary completion1 Aug 2023 (estimated)
- Study completion7 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical RadiculopathyStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gunay Yolcu, M.D., Principal investigator, Marmara UniversityOsman Hakan Gunduz, Prof., Study chair, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05960487
- Sponsor's protocol ID
- 09.2020.1203
- Status last verified
- Jul 2023
- First submitted
- 9 Jul 2023
- Last updated
- 25 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Multifidus Muscle Area Affect Cervical Interlaminar Epidural Steroid Injection Outcomes?
- ClinicalTrials.gov ID
- NCT05960487
- Acronym / sponsor ID
- 09.2020.1203
- Conditions
- Cervical Radiculopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 20 Jul 2023 (estimated)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 7 Aug 2023 (estimated)
- First posted
- 25 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The patients with a significant decrease in pain severity | – | Other: 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. |
| Patients without significant decrease in pain severity | – | Other: 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Patients without significant decrease in pain severity, The patients with a significant decrease in pain severity |
Primary outcome
Cervical multifidus muscle area
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gunay Yolcu, M.D. principal investigator
Marmara University
Osman Hakan Gunduz, Prof. study chair
Marmara University
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Radiculopathy, run by Marmara University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Savas Sencan, M.D. (+902166254545 ext. 1611, savas-44@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cervical multifidus muscle area (time frame: Through study completion, an average of 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2023.