The use of direct nerve visualisation with the Evotouch/7starscope compared to the conventional fluoroscopy technique for transforaminal epidural injection.

Phase 4

Conditions: nerve pain
Radicular pain
10041543

Registration Number: NL-OMON51663

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

1. Age 18 years or higher
2. Unilateral, single level radicular pain at level L2-L3, L3-L4, L4-L5 or L5-S1
3. Pain score of 4 or higher on a scale from 0-10

Exclusion Criteria

1. The presence of coagulation disorders or the use of anticoagulants that
interfere with the procedure and cannot be stopped during the procedure
2. Presence of an infection at the lumbar spine
3. History of a spinal tumor
4. Previous surgery with fixation of the lumbar spine
5. Serious spinal deformity inducing large anatomic alterations
6. Allergic reaction to contrast dye or local anaesthetics used during the
procedure
7. Inability to provide informed consent
8. Pregnancy

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Correct needle placement (Yes/No) as confirmed with fluoroscopy</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Inadvertent intravascular positioning (Yes/No)<br /><br>2. Brief pain inventory at baseline and 2, 4, 8 and 12 weeks after TFEI<br /><br>3. Global perceived effect at baseline and 2, 4, 8 and 12 weeks after TFEI<br /><br>4. Number of repositioning procedures required for adequate contrast spread<br /><br>around the nerve root.<br /><br>5. Procedure difficulty scoring scored by the pain specialist directly after<br /><br>the TFEI procedure.</p><br>