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Epidural Steroid Injections in Post-lumbar Surgery Syndrome After Single-level Discectomy

Primary Purpose

Failed Back Surgery Syndrome, Low Back Pain, Radiculopathy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Transforaminal epidural steroid injection
Caudal epidural steroid injection
Sponsored by
Marmara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Failed Back Surgery Syndrome focused on measuring Failed back surgery syndrome, epidural steroid injections

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age between 18 and 65 years
  • Previous single-level, open, non-fusion discectomy for L4-5 or L5-S1 lumbar disc herniation within the past six months
  • Having epidural fibrosis involving the L4, L5 or S1 nerve root on magnetic resonance imaging
  • Having low back and leg pain for at least six months and unresponsive to conservative therapies
  • A Numerical Rating Scale score of ≥4
  • Having a single-level epidural fibrosis in the operated level and side as assessed by contrast-enhanced spinal magnetic resonance imaging

Exclusion Criteria:

  • Having a multi-level epidural fibrosis
  • Previous surgery for multi-level disc herniation
  • Previous lumbar fusion surgery
  • Having recurrent disc hernia
  • Having sacroiliac/facet joint pain
  • Having lumbar spinal stenosis, spondylolysis, spondylolisthesis, or scoliosis
  • History of epidural steroid injection within the past six months
  • Having bleeding diathesis
  • Presence of systemic or local infections
  • Pregnancy
  • Known hypersensitivity to the injectates to be applied

Sites / Locations

  • Marmara University Pendik Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Transforaminal epidural steroid injection (TESI) group

Caudal epidural steroid injection (CESI) group

Arm Description

This procedure was applied only once. 1 to 2 cc of the contrast agent (300 mg/50 mL iohexol) was given and the distribution pattern was visualized. Once the epidural distribution of the contrast agent was confirmed without vascular flow, a mixture of 40 mg (1mL) of triamcinolone acetonide, 2 cc of physiological saline, and 2 cc (0.5%) of bupivacaine was injected.

This procedure was applied only once 1 to 2 cc of the contrast agent (300 mg/50 mL iohexol) was given and the distribution pattern was visualized which showed bilateral L5-S3 distribution without vascular flow. A mixture of 40 mg (1mL) of triamcinolone acetonide, 7 cc of physiological saline, and 2 cc (0.5%) of bupivacaine was injected. A total of 10 cc mixture was used for CESI.

Outcomes

Primary Outcome Measures

Change in pain severity
Numerical Rating Scale (NRS) is a scale for assessing the severity of pain. The numerical rating scale ranges from 0 to 10, with 0 being "no pain" and 10 being "worst pain imaginable". The patient chooses the most appropriate number describing the severity of pain (oral version).
Change in disability score
Modified Oswestry Disability Index (MODI) is a 10-question questionnaire assessing disability in low back pain. Each question has 6 options. The lowest score for each question is zero and the highest score is 5. High score is associated with increased disability.

Secondary Outcome Measures

Full Information

First Posted
October 11, 2021
Last Updated
October 21, 2021
Sponsor
Marmara University
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1. Study Identification

Unique Protocol Identification Number
NCT05099796
Brief Title
Epidural Steroid Injections in Post-lumbar Surgery Syndrome After Single-level Discectomy
Official Title
Comparison of Caudal Versus Transforaminal Epidural Steroid Injection in Post-lumbar Surgery Syndrome After Single-level Discectomy: A Prospective, Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
January 5, 2016 (Actual)
Primary Completion Date
May 11, 2021 (Actual)
Study Completion Date
May 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marmara University

4. Oversight

5. Study Description

Brief Summary
62 patients with postlumbar surgery syndrome were randomized and divided into two groups. Transforaminal epidural steroid injection (TFESI) was applied to the TFESI group (n=31), and caudal epidural steroid injection (CESI) was applied to the CESI group (n=31). The age of the patients involved in this study ranged from 18 years old to 65 years old
Detailed Description
Patients with low back and radicular pain related to epidural fibrosis following single-level lumbar discectomy were included. The patients were randomly divided into two groups as the CESI group and TFESI group. Transforaminal epidural steroid injection was applied to the TFESI group (n=31), and caudal epidural steroid injection was applied to the CESI group (n=31). All patients were assessed before the procedure (baseline) and at 1 hour, three weeks, and three months after the procedure using the Numerical Rating Scale (NRS) and at baseline and three weeks and three months using the modified Oswestry Disability Index (mODI). Treatment success was defined as ≥50% decrease in the NRS scores compared to baseline

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Failed Back Surgery Syndrome, Low Back Pain, Radiculopathy, Epidural Fibrosis
Keywords
Failed back surgery syndrome, epidural steroid injections

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transforaminal epidural steroid injection (TESI) group
Arm Type
Active Comparator
Arm Description
This procedure was applied only once. 1 to 2 cc of the contrast agent (300 mg/50 mL iohexol) was given and the distribution pattern was visualized. Once the epidural distribution of the contrast agent was confirmed without vascular flow, a mixture of 40 mg (1mL) of triamcinolone acetonide, 2 cc of physiological saline, and 2 cc (0.5%) of bupivacaine was injected.
Arm Title
Caudal epidural steroid injection (CESI) group
Arm Type
Active Comparator
Arm Description
This procedure was applied only once 1 to 2 cc of the contrast agent (300 mg/50 mL iohexol) was given and the distribution pattern was visualized which showed bilateral L5-S3 distribution without vascular flow. A mixture of 40 mg (1mL) of triamcinolone acetonide, 7 cc of physiological saline, and 2 cc (0.5%) of bupivacaine was injected. A total of 10 cc mixture was used for CESI.
Intervention Type
Procedure
Intervention Name(s)
Transforaminal epidural steroid injection
Intervention Type
Procedure
Intervention Name(s)
Caudal epidural steroid injection
Primary Outcome Measure Information:
Title
Change in pain severity
Description
Numerical Rating Scale (NRS) is a scale for assessing the severity of pain. The numerical rating scale ranges from 0 to 10, with 0 being "no pain" and 10 being "worst pain imaginable". The patient chooses the most appropriate number describing the severity of pain (oral version).
Time Frame
All patients were assessed from baseline to each checkpoint (at 1 hour, three weeks, and three months after the procedure)
Title
Change in disability score
Description
Modified Oswestry Disability Index (MODI) is a 10-question questionnaire assessing disability in low back pain. Each question has 6 options. The lowest score for each question is zero and the highest score is 5. High score is associated with increased disability.
Time Frame
All patients were assessed from baseline to each checkpoint (at 1 hour, three weeks, and three months after the procedure)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 18 and 65 years Previous single-level, open, non-fusion discectomy for L4-5 or L5-S1 lumbar disc herniation within the past six months Having epidural fibrosis involving the L4, L5 or S1 nerve root on magnetic resonance imaging Having low back and leg pain for at least six months and unresponsive to conservative therapies A Numerical Rating Scale score of ≥4 Having a single-level epidural fibrosis in the operated level and side as assessed by contrast-enhanced spinal magnetic resonance imaging Exclusion Criteria: Having a multi-level epidural fibrosis Previous surgery for multi-level disc herniation Previous lumbar fusion surgery Having recurrent disc hernia Having sacroiliac/facet joint pain Having lumbar spinal stenosis, spondylolysis, spondylolisthesis, or scoliosis History of epidural steroid injection within the past six months Having bleeding diathesis Presence of systemic or local infections Pregnancy Known hypersensitivity to the injectates to be applied
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Savas Sencan, Assoc. Prof.
Organizational Affiliation
Marmara University Pendik Training and Research Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Marmara University Pendik Training and Research Hospital
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Epidural Steroid Injections in Post-lumbar Surgery Syndrome After Single-level Discectomy

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