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

NCT05374850 | Unknown

• 1 other identifier: 07.01.2022.82
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. We hypothesized that participants with abnormal cervical spine alignment parameters were less likely to benefit from treatment.

Conditions

Cervical Disc Herniation

Keywords

cervical sagittal parameters

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  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)

  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

Interventions

Cervical Interlaminar Epidural Steroid Injection PROCEDURE

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

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University Pendik Training and Research Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (5)

• 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.

  PMID: 32709169 BACKGROUND

• 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.

  PMID: 33492918 BACKGROUND

• 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.

  PMID: 33772659 BACKGROUND

• 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.

  PMID: 26571157 BACKGROUND

• 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.

  PMID: 29095412 BACKGROUND

Study Officials

• SAVAS SENCAN

  Marmara University Pendik Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

RIDVAN ISIK

CONTACT

+905412427317; dr.ridvanisik@gmail.com

JANBUBI JANDAULYET

CONTACT

+905076755161; janbubi18@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2022
• First Posted: May 16, 2022
• Study Start: June 1, 2022
• Primary Completion: June 1, 2022
• Study Completion: August 1, 2022
• Last Updated: May 16, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)