Comparison of Transforaminal vs. Parasagittal Interlaminar Epidural Injection

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.

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Key information

Conditions

Spinal Stenosis Bone Diseases Musculoskeletal Diseases Spinal Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

central spinal stenosis
herniated nucleus pulposus.

Exclusion criteria

Lateral spinal stenosis
Internal disc disruption

Treatment and study plan

epidural steroid (dexamethasone) injection

Procedure

spinal injections performed in epidural space to relieve chronic low back pain or leg pain

Primary outcomes

Clinical efficacy

Time frame: 2 weeks after study completion

Numerical rating scale

Secondary outcomes

Intervention related time

Time frame: 1 minutes after the completion of the intervention

time required to complete the intervention
Exposed radiation amount during intervention

Time frame: 1 minutes after the completion of the intervention

Exposed radiation amount during intervention

Sponsors and collaborators

Lead sponsor

Keimyung University Dongsan Medical Center

Other

Registry information

Official study title

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

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Jul 20, 2016
Registry last updated: Nov 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed