Impact of Cervical Parameters to Interlaminar Epidural Steroid Injection Treatment Outcomes in Patients With Cervical Disc Herniation

NCT ID: NCT05374850

Last Updated: 2022-05-16

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

2022-06-30

Study Completion Date

2022-08-31

Brief Summary

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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

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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

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Cervical Disc Herniation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Cervical Interlaminar Epidural Steroid Injection

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* 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,
* Known allergy to contrast material and/or local anesthetic substances,
* Known history of any psychiatric disorder
* Patients with a history of pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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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SAVAS SENCAN

Role: PRINCIPAL_INVESTIGATOR

Marmara University Pendik Training and Research Hospital

Locations

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Marmara University Pendik Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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RIDVAN ISIK

Role: CONTACT

+905412427317

JANBUBI JANDAULYET

Role: CONTACT

+905076755161

Facility Contacts

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RIDVAN ISIK

Role: primary

+905412427317

References

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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.

Reference Type BACKGROUND
PMID: 32709169 (View on PubMed)

Manchikanti 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.

Reference Type BACKGROUND
PMID: 33492918 (View on PubMed)

Azimi 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.

Reference Type BACKGROUND
PMID: 33772659 (View on PubMed)

Iyer 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.

Reference Type BACKGROUND
PMID: 26571157 (View on PubMed)

Nicholson 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.

Reference Type BACKGROUND
PMID: 29095412 (View on PubMed)

Other Identifiers

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07.01.2022.82

Identifier Type: -

Identifier Source: org_study_id

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