Cervical Disc HerniationNCT05638074
Does the Presence of Cervical Facet Tropism Affect the Response to Interlaminar Epidural Steroid Injections?
An observational study of Cervical Disc Herniation and Cervical Radicular Pain, run by Janbubi Jandaulyet at 1 site in Turkey (Türkiye).
Trial summary
Facet joints are synovial joints located on the dorsolateral side of the vertebral column. Normally, both facet joints are symmetrical. Facet tropism (FT) is defined as asymmetry between the angles of orientation of the joints, in which a facet joint in the same segment is more sagittally oriented than the other. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cervical Disc Herniation, Cervical Radicular Pain, Facet Tropism
- What is being tested?
- Interlaminar Epidural Steroid Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Nov 2022to 30 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients who applied to the pain medicine outpatient clinic
Who may be able to join
- aged 18-75 years, who applied to the pain medicine outpatient clinic, had axial neck and unilateral radicular extremity pain for at least 3 months, and were diagnosed with protruded disc herniation by magnetic resonance imaging were included in the study
Who cannot join
- Patients with systemic inflammatory disease, bleeding diathesis,history of psychiatric illness, malignancy, contrast material or local anesthetic agent allergy, cervical spinal stenosis, history of cervical ESI, or neck surgery in the last 3 months were excluded from the study
Trial locations and contacts
1 site in 1 country.
savas sencan, Assosiate Professor contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Marmara University Pendik Training and Research Hospital
Istanbul, Pendik, 34899
janbubi jandaulyet, +905076755161, janbubi.jandaulyet@marmara.edu.tr
About this study
Official title: Does the Presence of Cervical Facet Tropism Affect the Response to Interlaminar Epidural Steroid Injections? A Prospective Clinical Study
Facet joints are synovial joints located on the dorsolateral side of the vertebral column. Normally, both facet joints are symmetrical. Facet tropism (FT) is defined as asymmetry between the angles of orientation of the joints, in which a facet joint in the same segment is more sagittally oriented than the other. In 1967, Farfan and Sullivan first reported that FT is a possible risk factor for the development of disk herniation. However, this is controversial as there are other views advocating that FT is not a risk factor for the development of cervical disc herniation. Further, it has been emphasized that patients with FT have a greater need for adjacent segment degeneration and new spinal surgery after spinal fusion surgeries than those without FT.
In the current literature, studies have been conducted to examine the clinical and radiological parameters that may be related to the effectiveness of cervical interlaminar epidural steroid injections (ILESI). The aim of this study was to examine the effect of the presence of FT on ILESI results in patients with cervical disc herniation-induced radicular pain.
- Being tested
- Interlaminar Epidural Steroid Injection
- Keywords
- facet tropism, cervical disc herniation, Cervical Radicular Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interlaminar Epidural Steroid InjectionProcedure or surgery
The patient will be placed in the prone position and cutaneous anesthesia is performed with 3 mL of 2% prilocaine using the sterile technique. After imaging the C7-T1 space with fluoroscopy, it will be entered from the right/left paramedian part of the C7-T1 space with an 18G Touhy needle, and the C-arm will be set in the contralateral oblique position for depth determination.
Under intermittent fluoroscopic imaging, the needle will be advanced, and access to the epidural space wiil be confirmed by the loss of resistance technique. Afterwards, the epidural spread will be controlled with a contrast agent, and a mixture of 10 mg dexamethasone, 1 mL 2% lidocaine hydrochloride, and 1 mL 0.9% saline will be applied to the epidural space. The patient will be discharged with recommendations after being kept under observation for 2 hours post-procedure. All injections will be performed by the same pain medicine specialist who has at least 5 years of experience.
| Study group | Role | What they receive |
|---|---|---|
| With cervical facet tropism | Not described Receives: Procedure: Interlaminar Epidural Steroid Injection | |
| Without cervical facet tropism | Not described Receives: Procedure: Interlaminar Epidural Steroid Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS score
≥50% reduction in the NRS scores at month 3 relative to the initial NRS scores.
Measured: at first hour, at three weeks, at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start28 Nov 2022 (estimated)
- Primary completion30 May 2023 (estimated)
- Study completion30 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical Disc HerniationStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Janbubi Jandaulyet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Janbubi Jandaulyet, Marmara University
- Investigators
- Osman Hakan Gunduz, Professor, Study director, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05638074
- Sponsor's protocol ID
- 04.11.2022.1506
- Status last verified
- Nov 2022
- First submitted
- 25 Nov 2022
- Last updated
- 6 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Celenlioglu AE, Sencan S, Gunduz OH. Does facet tropism negatively affect the response to transforaminal epidural steroid injections? A prospective clinical study. Skeletal Radiol. 2019 Jul;48(7):1051-1058. doi: 10.1007/s00256-018-3129-8. Epub 2019 Jan 2.
PubMed 30603772
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Presence of Cervical Facet Tropism Affect the Response to Interlaminar Epidural Steroid Injections? A Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT05638074
- Acronym / sponsor ID
- 04.11.2022.1506
- Keywords
- facet tropism, cervical disc herniation, Cervical Radicular Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Janbubi JandaulyetUniversity, hospital or other
- Study start
- 28 Nov 2022 (estimated)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 6 Dec 2022 (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.
Facet joints are synovial joints located on the dorsolateral side of the vertebral column. Normally, both facet joints are symmetrical. Facet tropism (FT) is defined as asymmetry between the angles of orientation of the joints, in which a facet joint in the same segment is more sagittally oriented than the other. In 1967, Farfan and Sullivan first reported that FT is a possible risk factor for the development of disk herniation. However, this is controversial as there are other views advocating that FT is not a risk factor for the development of cervical disc herniation. Further, it has been emphasized that patients with FT have a greater need for adjacent segment degeneration and new spinal surgery after spinal fusion surgeries than those without FT.
In the current literature, studies have been conducted to examine the clinical and radiological parameters that may be related to the effectiveness of cervical interlaminar epidural steroid injections (ILESI). The aim of this study was to examine the effect of the presence of FT on ILESI results in patients with cervical disc herniation-induced radicular pain.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With cervical facet tropism | – | Procedure: Interlaminar Epidural Steroid Injection |
| Without cervical facet tropism | – | Procedure: Interlaminar Epidural Steroid Injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who applied to the pain medicine outpatient clinic
Key inclusion criteria (1 listed)
- aged 18-75 years, who applied to the pain medicine outpatient clinic, had axial neck and unilateral radicular extremity pain for at least 3 months, and were diagnosed with protruded disc herniation by magnetic resonance imaging were included in the study
Key exclusion criteria (1 listed)
- Patients with systemic inflammatory disease, bleeding diathesis,history of psychiatric illness, malignancy, contrast material or local anesthetic agent allergy, cervical spinal stenosis, history of cervical ESI, or neck surgery in the last 3 months were excluded from the study
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 |
|---|---|---|
| Interlaminar Epidural Steroid InjectionThe patient will be placed in the prone position and cutaneous anesthesia is performed with 3 mL of 2% prilocaine using the sterile technique. After imaging the C7-T1 space with fluoroscopy, it will be entered from the right/left paramedian part of the C7-T1 space with an 18G Touhy needle, and the C-arm will be set in the contralateral oblique position for depth determination. Under intermittent fluoroscopic imaging, the needle will be advanced, and access to the epidural space wiil be confirmed by the loss of resistance technique. Afterwards, the epidural spread will be controlled with a contrast agent, and a mixture of 10 mg dexamethasone, 1 mL 2% lidocaine hydrochloride, and 1 mL 0.9% saline will be applied to the epidural space. The patient will be discharged with recommendations after being kept under observation for 2 hours post-procedure. All injections will be performed by the same pain medicine specialist who has at least 5 years of experience. | Procedure or surgery | With cervical facet tropism, Without cervical facet tropism |
Primary outcome
NRS score
Time frame: at first hour, at three weeks, at 3 months
≥50% reduction in the NRS scores at month 3 relative to the initial NRS scores.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
- Results publication: PubMed 30603772Celenlioglu AE, Sencan S, Gunduz OH. Does facet tropism negatively affect the response to transforaminal epidural steroid injections? A prospective clinical study. Skeletal Radiol. 2019 Jul;48(7):1051-1058. doi: 10.1007/s00256-018-3129-8. Epub 2019 Jan 2.
- 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.
savas sencan, Assosiate Professor contact
Osman Hakan Gunduz, Professor study director
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Disc Herniation and Cervical Radicular Pain, run by Janbubi Jandaulyet at 1 site in Turkey (Türkiye).
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 1 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 6 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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 janbubi jandaulyet, residency (+905076755161, janbubi.jandaulyet@marmara.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NRS score (time frame: at first hour, at three weeks, at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05638074, which also lists 1 linked publication.
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 6 Dec 2022.