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
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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UNKNOWN
60 participants
OBSERVATIONAL
2022-06-30
2022-08-31
Brief Summary
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Detailed Description
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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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Study Design
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COHORT
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
65 Years
ALL
No
Sponsors
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Marmara University
OTHER
Responsible Party
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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)
Countries
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Central Contacts
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Facility Contacts
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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.
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.
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.
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.
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.
Other Identifiers
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07.01.2022.82
Identifier Type: -
Identifier Source: org_study_id
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