Cervical Disc HerniationNCT05374850
Impact of Cervical Parameters to Interlaminar Epidural Steroid Injection Treatment Outcomes in Patients With Cervical Disc Herniation
An observational study of Cervical Disc Herniation, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
This study is aim to disclose the effect of cervical parameters, whether they change the outcomes of epidural steroid injection treatment in patients with cervical disc herniation. The patients who had cervical disc herniation and had been performed interlaminar epidural steroid injection were included. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cervical Disc Herniation
- What is being tested?
- Cervical Interlaminar Epidural Steroid Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2022to Aug 2022
- How long will I take part?
- 4 Months
- 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 ,between the ages of 18 and 65, who diagnosed with cervical radiculopathy due to disc herniation in our pain clinic and who are resistant to conservative treatment, so the patients to be treated with ILESI procedure.
Who may be able to join
- Patients who have suffered from neck pain for at least 3 months and been diagnosed with cervical radiculopathy
- Intractable pain despite conservative treatment and being between the ages of 18 and 65
- Patients who will be performing with an interlaminar epidural steroid injection(ILESI)
Who cannot join
- Patients with a history of ILESI carried out in the previous 3 months,
- Patients with a history of cervical surgery,
- Patients with systemic and/or local infections,
- Malignancy,
- Bleeding diathesis,
- Acute fracture,
Show all 9Show fewer
- Known allergy to contrast material and/or local anesthetic substances,
- Known history of any psychiatric disorder
- Patients with a history of pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Marmara University Pendik Training and Research Hospital
Istanbul
RIDVAN ISIK, +905412427317, dr.ridvanisik@gmail.com
SAVAS SENCAN
About this study
Official title: Impact of Cervical Sagittal Parameters on Interlaminar Epidural Steroid Injection Treatment Outcomes in Patients With Cervical Disc Herniation
This study is aim to disclose the effect of cervical parameters, whether they change the outcomes of epidural steroid injection treatment in patients with cervical disc herniation. The patients who had cervical disc herniation and had been performed interlaminar epidural steroid injection were included. We hypothesized that participants with abnormal cervical spine alignment parameters were less likely to benefit from treatment.
Read the detailed description
The objective of this study is to reveal the impact of cervical sagittal parameters on interlaminar epidural steroid injections in patients with cervical disc herniation. Patients who have suffered from cervical radicular pain for at least 3 months and been diagnosed with cervical radiculopathy in our pain clinic in the subsequent stage, with a clinical and physical examination, as well as radiologic assessments, were included in the study. Other inclusion criteria were intractable pain over the neck despite conservative treatment and being between the ages of 18 and 65. Patients with a history of epidural steroid injections carried out in the previous 3 months, patients with a history of cervical spine surgery, patients with systemic and/or local infections, malignancy, bleeding diathesis, acute fracture, known allergy to contrast material and/or local anesthetic substances, known history of any psychiatric disorder, and patients with a history of pregnancy were excluded from the study. Verbal and written informed consent was obtained from all patients participating in the study.
In addition to the recording of the demographic data of the patients participating in this study (age, sex, duration of symptoms, etc.), their sagittal parameters angles (C2-C7 cervical lordosis, C2-C7 sagittal vertical axis, C7 slope and spino-cranial angle) and the numeric rating scale (NRS) was employed before the procedure and in the 1st hour, 3rd week, and 3rd month after the procedure. Short Form-12 Health Survey (SF-12) was employed before the procedure and in the 3rd week and 3rd month after the procedure.
- Conditions
- Cervical Disc Herniation
- Being tested
- Cervical Interlaminar Epidural Steroid Injection
- Keywords
- cervical sagittal parameters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical Interlaminar Epidural Steroid InjectionProcedure or surgery
This intervention is applied mostly for cervical disc herniation.The intervention was carried out under sterile conditions with the C-arm fluoroscopy guidance. It is performed via spinal needle and the needle is inserted into the epidural space, then combined local anesthetics and glucocorticoids is delivered to the epidural space.
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale (NRS)
A numeric (or numerical) scale, also known as a Numerical Rating Scale (NRS), is basically any scale that renders a quantitative symbolization of an attribute. This type of scale is used by presenting the respondent with an ordered set from which to choose, for example, 1 to 10, coupled with anchors. These anchors can be put at the endpoints or at each point on the scale.
Measured: Change of pain severity from baseline to each checkpoints from pre-interventional time to post-interventional 1st hour, 3rd week and 3rd month
Secondary outcomes (2)
Short-form 12(SF-12)
The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure.
Measured: Change of life quality from baseline to each checkpoints from pre-interventional time to post-interventional 3rd week and 3rd month
The Neck Disability Index (NDI)
Patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation.
Measured: Change of functionality from baseline to each checkpoints from baseline to each checkpoints from pre-interventional time to post-interventional 3rd week and 3rd month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2022
- Study startJun 2022 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cervical Disc HerniationStudies 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
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- SAVAS SENCAN, Principal investigator, Marmara University Pendik Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05374850
- Sponsor's protocol ID
- 07.01.2022.82
- Status last verified
- May 2022
- First submitted
- 20 Apr 2022
- Last updated
- 16 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mesregah MK, Feng W, Huang WH, Chen WC, Yoshida B, Mecum A, Mandalia K, Van Halm-Lutterodt N. Clinical Effectiveness of Interlaminar Epidural Injections of Local Anesthetic with or without Steroids for Managing Chronic Neck Pain: A Systematic Review and Meta-Analysis. Pain Physician. 2020 Jul;23(4):335-348.
PubMed 32709169Manchikanti L, Knezevic NN, Navani A, Christo PJ, Limerick G, Calodney AK, Grider J, Harned ME, Cintron L, Gharibo CG, Shah S, Nampiaparampil DE, Candido KD, Soin A, Kaye AD, Kosanovic R, Magee TR, Beall DP, Atluri S, Gupta M, Helm Ii S, Wargo BW, Diwan S, Aydin SM, Boswell MV, Haney BW, Albers SL, Latchaw R, Abd-Elsayed A, Conn A, Hansen H, Simopoulos TT, Swicegood JR, Bryce DA, Singh V, Abdi S, Bakshi S, Buenaventura RM, Cabaret JA, Jameson J, Jha S, Kaye AM, Pasupuleti R, Rajput K, Sanapati MR, Sehgal N, Trescot AM, Racz GB, Gupta S, Sharma ML, Grami V, Parr AT, Knezevic E, Datta S, Patel KG, Tracy DH, Cordner HJ, Snook LT, Benyamin RM, Hirsch JA. Epidural Interventions in the Management of Chronic Spinal Pain: American Society of Interventional Pain Physicians (ASIPP) Comprehensive Evidence-Based Guidelines. Pain Physician. 2021 Jan;24(S1):S27-S208.
PubMed 33492918Azimi P, Yazdanian T, Benzel EC, Hai Y, Montazeri A. Sagittal balance of the cervical spine: a systematic review and meta-analysis. Eur Spine J. 2021 Jun;30(6):1411-1439. doi: 10.1007/s00586-021-06825-0. Epub 2021 Mar 27.
PubMed 33772659Iyer S, Nemani VM, Nguyen J, Elysee J, Burapachaisri A, Ames CP, Kim HJ. Impact of Cervical Sagittal Alignment Parameters on Neck Disability. Spine (Phila Pa 1976). 2016 Mar;41(5):371-7. doi: 10.1097/BRS.0000000000001221.
PubMed 26571157Nicholson KJ, Millhouse PW, Pflug E, Woods B, Schroeder GD, Anderson DG, Hilibrand AS, Kepler CK, Kurd MF, Rihn JA, Vaccaro A, Radcliff KE. Cervical Sagittal Range of Motion as a Predictor of Symptom Severity in Cervical Spondylotic Myelopathy. Spine (Phila Pa 1976). 2018 Jul 1;43(13):883-889. doi: 10.1097/BRS.0000000000002478.
PubMed 29095412
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Cervical Sagittal Parameters on Interlaminar Epidural Steroid Injection Treatment Outcomes in Patients With Cervical Disc Herniation
- ClinicalTrials.gov ID
- NCT05374850
- Acronym / sponsor ID
- 07.01.2022.82
- Conditions
- Cervical Disc Herniation
- Keywords
- cervical sagittal parameters
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- Jun 2022 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 16 May 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.
This study is aim to disclose the effect of cervical parameters, whether they change the outcomes of epidural steroid injection treatment in patients with cervical disc herniation. The patients who had cervical disc herniation and had been performed interlaminar epidural steroid injection were included. We hypothesized that participants with abnormal cervical spine alignment parameters were less likely to benefit from treatment.
Detailed description
The objective of this study is to reveal the impact of cervical sagittal parameters on interlaminar epidural steroid injections in patients with cervical disc herniation. Patients who have suffered from cervical radicular pain for at least 3 months and been diagnosed with cervical radiculopathy in our pain clinic in the subsequent stage, with a clinical and physical examination, as well as radiologic assessments, were included in the study. Other inclusion criteria were intractable pain over the neck despite conservative treatment and being between the ages of 18 and 65. Patients with a history of epidural steroid injections carried out in the previous 3 months, patients with a history of cervical spine surgery, patients with systemic and/or local infections, malignancy, bleeding diathesis, acute fracture, known allergy to contrast material and/or local anesthetic substances, known history of any psychiatric disorder, and patients with a history of pregnancy were excluded from the study. Verbal and written informed consent was obtained from all patients participating in the study.
In addition to the recording of the demographic data of the patients participating in this study (age, sex, duration of symptoms, etc.), their sagittal parameters angles (C2-C7 cervical lordosis, C2-C7 sagittal vertical axis, C7 slope and spino-cranial angle) and the numeric rating scale (NRS) was employed before the procedure and in the 1st hour, 3rd week, and 3rd month after the procedure. Short Form-12 Health Survey (SF-12) was employed before the procedure and in the 3rd week and 3rd month after the procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Months
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients ,between the ages of 18 and 65, who diagnosed with cervical radiculopathy due to disc herniation in our pain clinic and who are resistant to conservative treatment, so the patients to be treated with ILESI procedure.
Key inclusion criteria (3 listed)
- Patients who have suffered from neck pain for at least 3 months and been diagnosed with cervical radiculopathy
- Intractable pain despite conservative treatment and being between the ages of 18 and 65
- Patients who will be performing with an interlaminar epidural steroid injection(ILESI)
Key exclusion criteria (9 listed)
- Patients with a history of ILESI carried out in the previous 3 months,
- Patients with a history of cervical surgery,
- Patients with systemic and/or local infections,
- Malignancy,
- Bleeding diathesis,
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 Interlaminar Epidural Steroid InjectionThis intervention is applied mostly for cervical disc herniation.The intervention was carried out under sterile conditions with the C-arm fluoroscopy guidance. It is performed via spinal needle and the needle is inserted into the epidural space, then combined local anesthetics and glucocorticoids is delivered to the epidural space. | Procedure or surgery | – |
Primary outcome
Numeric Rating Scale (NRS)
Time frame: Change of pain severity from baseline to each checkpoints from pre-interventional time to post-interventional 1st hour, 3rd week and 3rd month
A numeric (or numerical) scale, also known as a Numerical Rating Scale (NRS), is basically any scale that renders a quantitative symbolization of an attribute. This type of scale is used by presenting the respondent with an ordered set from which to choose, for example, 1 to 10, coupled with anchors. These anchors can be put at the endpoints or at each point on the scale.
2 secondary outcomes
Short-form 12(SF-12)
Time frame: Change of life quality from baseline to each checkpoints from pre-interventional time to post-interventional 3rd week and 3rd month
The Neck Disability Index (NDI)
Time frame: Change of functionality from baseline to each checkpoints from baseline to each checkpoints from pre-interventional time to post-interventional 3rd week and 3rd month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2022.
- Background: PubMed 32709169Mesregah MK, Feng W, Huang WH, Chen WC, Yoshida B, Mecum A, Mandalia K, Van Halm-Lutterodt N. Clinical Effectiveness of Interlaminar Epidural Injections of Local Anesthetic with or without Steroids for Managing Chronic Neck Pain: A Systematic Review and Meta-Analysis. Pain Physician. 2020 Jul;23(4):335-348.
- Background: PubMed 33492918Manchikanti L, Knezevic NN, Navani A, Christo PJ, Limerick G, Calodney AK, Grider J, Harned ME, Cintron L, Gharibo CG, Shah S, Nampiaparampil DE, Candido KD, Soin A, Kaye AD, Kosanovic R, Magee TR, Beall DP, Atluri S, Gupta M, Helm Ii S, Wargo BW, Diwan S, Aydin SM, Boswell MV, Haney BW, Albers SL, Latchaw R, Abd-Elsayed A, Conn A, Hansen H, Simopoulos TT, Swicegood JR, Bryce DA, Singh V, Abdi S, Bakshi S, Buenaventura RM, Cabaret JA, Jameson J, Jha S, Kaye AM, Pasupuleti R, Rajput K, Sanapati MR, Sehgal N, Trescot AM, Racz GB, Gupta S, Sharma ML, Grami V, Parr AT, Knezevic E, Datta S, Patel KG, Tracy DH, Cordner HJ, Snook LT, Benyamin RM, Hirsch JA. Epidural Interventions in the Management of Chronic Spinal Pain: American Society of Interventional Pain Physicians (ASIPP) Comprehensive Evidence-Based Guidelines. Pain Physician. 2021 Jan;24(S1):S27-S208.
- Background: PubMed 33772659Azimi P, Yazdanian T, Benzel EC, Hai Y, Montazeri A. Sagittal balance of the cervical spine: a systematic review and meta-analysis. Eur Spine J. 2021 Jun;30(6):1411-1439. doi: 10.1007/s00586-021-06825-0. Epub 2021 Mar 27.
- Background: PubMed 26571157Iyer S, Nemani VM, Nguyen J, Elysee J, Burapachaisri A, Ames CP, Kim HJ. Impact of Cervical Sagittal Alignment Parameters on Neck Disability. Spine (Phila Pa 1976). 2016 Mar;41(5):371-7. doi: 10.1097/BRS.0000000000001221.
- Background: PubMed 29095412Nicholson KJ, Millhouse PW, Pflug E, Woods B, Schroeder GD, Anderson DG, Hilibrand AS, Kepler CK, Kurd MF, Rihn JA, Vaccaro A, Radcliff KE. Cervical Sagittal Range of Motion as a Predictor of Symptom Severity in Cervical Spondylotic Myelopathy. Spine (Phila Pa 1976). 2018 Jul 1;43(13):883-889. doi: 10.1097/BRS.0000000000002478.
- Individual participant dataSharing planned: No
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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 principal investigator
Marmara University Pendik Training and Research Hospital
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, run by Marmara University 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 3 inclusion and 9 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 16 May 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 RIDVAN ISIK (+905412427317, dr.ridvanisik@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Rating Scale (NRS) (time frame: Change of pain severity from baseline to each checkpoints from pre-interventional time to post-interventional 1st hour, 3rd week and 3rd month). 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 NCT05374850, which also lists 5 linked publications.
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 16 May 2022.