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

Low Back Pain Clinical Trial

Official title:

Comparison of Caudal Versus Transforaminal Epidural Steroid Injection in Post-lumbar Surgery Syndrome After Single-level Discectomy: A Prospective, Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05099796
• Other study ID #: 09.2014.0085
• Status: Completed
• Phase: N/A
• Start date: January 5, 2016
• Est. completion date: May 11, 2021

Study information

• Verified date: October 2021
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: May 11, 2021
• Est. primary completion date: May 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Epidural Fibrosis
• Failed Back Surgery Syndrome
• Low Back Pain
• Radiculopathy
• Syndrome

Intervention

Procedure:
• Transforaminal epidural steroid injection

• Caudal epidural steroid injection

Locations

Country	Name	City	State
Turkey	Marmara University Pendik Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	All patients were assessed from baseline to each checkpoint (at 1 hour, three weeks, and three months after the procedure)
Primary	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.	All patients were assessed from baseline to each checkpoint (at 1 hour, three weeks, and three months after the procedure)