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

NCT05099796 | Completed

• 1 other identifier: 09.2014.0085
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

Failed back surgery syndrome, epidural steroid injections

Outcome Measures

Primary Outcomes (2)

• 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)

• 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)

Study Arms (2)

Transforaminal epidural steroid injection (TESI) group

ACTIVE COMPARATOR

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.

Procedure: Transforaminal epidural steroid injection

Caudal epidural steroid injection (CESI) group

ACTIVE COMPARATOR

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.

Procedure: Caudal epidural steroid injection

Interventions

Transforaminal epidural steroid injection PROCEDURE

Transforaminal epidural steroid injection (TESI) group

Caudal epidural steroid injection PROCEDURE

Caudal epidural steroid injection (CESI) group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University Pendik Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Failed Back Surgery Syndrome; Low Back Pain; Radiculopathy

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Savas Sencan, Assoc. Prof.

  Marmara University Pendik Training and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: October 29, 2021
• Study Start: January 5, 2016
• Primary Completion: May 11, 2021
• Study Completion: May 11, 2021
• Last Updated: October 29, 2021

Record last verified: 2021-10

Locations

TU (1)