Comparison of Transforaminal vs. Parasagittal Interlaminar Epidural Injection

Spinal Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02838615
• Other study ID #: 2016-05-029
• Status: Completed
• Phase: N/A
• First received: May 25, 2016
• Last updated: November 28, 2017
• Start date: July 2016
• Est. completion date: June 2017

Study information

• Verified date: November 2017
• Source: Keimyung University Dongsan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: June 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• central spinal stenosis

• herniated nucleus pulposus.

Exclusion Criteria:

• Lateral spinal stenosis

• Internal disc disruption

Related Conditions & MeSH terms

• Spinal Stenosis

Intervention

Procedure:
• epidural steroid (dexamethasone) injection
spinal injections performed in epidural space to relieve chronic low back pain or leg pain

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Keimyung University Dongsan Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical efficacy	Numerical rating scale	2 weeks after study completion
Secondary	Intervention related time	time required to complete the intervention	1 minutes after the completion of the intervention
Secondary	Exposed radiation amount during intervention	Exposed radiation amount during intervention	1 minutes after the completion of the intervention