Comparison of Transforaminal vs. Parasagittal Interlaminar Epidural Injection

Comparison of Lumbar Epidural Steroid Injection: Transforaminal vs. Parasagittal Interlaminar Approach

The purpose of this study is to compare the clinical efficacy, incidence of ventral epidural spreading and provocation of concordant paresthesia, amount of radiation exposure and total procedure time between transforaminal and parasagittal interlaminar epidural injection.

Study Overview

• Status: Completed
• Conditions: Spinal Stenosis
• Intervention / Treatment: Procedure: epidural steroid (dexamethasone) injection

Detailed Description

Participants were randomly allocated to receive either parasagittal interlaminar or transforaminal ESI.

Investigators obtained clinical data including age, gender, duration of symptoms, predominant symptoms (axial pain vs. leg pain), severity of neurogenic intermittent claudication (NIC) and degree of depression. Depression was assessed by the Korean version of the Beck Depression Inventory (BDI). The BDI is a standardized questionnaire to assess cognitive, affective, and somatic symptoms of depression. All data were obtained before performing ESI.Data about anterior epidural spreading and presence of concordant pain provocation were obtained during fluoroscopic guided parasagittal interlaminar or transforaminal ESI. Also total procedure time and amount of radiation exposure were checked. Investigators observed the epidural spread pattern after a 2 ml injection of contrast material, confirmed anterior epidural spread with a lateral view, and asked the participants if they had any concordant pain provocation or not. The participants were asked if the pain was in the same distribution as their original pain (concordant) or dissimilar or absent in both quality and location.

Investigators used the numerical rating scale (NRS) as well as the Korean version of the Oswestry Disability Index (ODI) to evaluate clinical efficacy in terms of reducing pain and functional improvement at pretreatment and 2 weeks after the ESI series. ESI was performed twice with a 2 weeks interval before the final treatment outcome evaluation with the NRS and ODI. All patients reported average severity of their symptoms over the previous 1 week. A score of 0 on the NRS represents no pain, and a score of 10 represents the worst pain imaginable. The Korean version of the ODI (0-50) was used to assess functional improvement.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• central spinal stenosis
• herniated nucleus pulposus.

Exclusion Criteria:

• Lateral spinal stenosis
• Internal disc disruption

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: epidural steroid injection; TF epidural steroid (dexamethasone) injection	Procedure: epidural steroid (dexamethasone) injection; spinal injections performed in epidural space to relieve chronic low back pain or leg pain
ACTIVE_COMPARATOR: IL epidural steroid injection; PS interlaminar epidural steroid(dexamethasone) injection	Procedure: epidural steroid (dexamethasone) injection; spinal injections performed in epidural space to relieve chronic low back pain or leg pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical efficacy	Numerical rating scale	2 weeks after study completion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention related time	time required to complete the intervention	1 minutes after the completion of the intervention
Exposed radiation amount during intervention	Exposed radiation amount during intervention	1 minutes after the completion of the intervention

Collaborators and Investigators

• Sponsor: Keimyung University Dongsan Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (ACTUAL): May 1, 2017
• Study Completion (ACTUAL): June 1, 2017

Study Registration Dates

• First Submitted: May 25, 2016
• First Submitted That Met QC Criteria: July 19, 2016
• First Posted (ESTIMATE): July 20, 2016

Study Record Updates

• Last Update Posted (ACTUAL): November 29, 2017
• Last Update Submitted That Met QC Criteria: November 28, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: spinal stenosis; epidural steroid injection
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Stenosis; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: 2016-05-029

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO