Skip to content

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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON51663
Enrollment
50
Registered
2022-09-15
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radicular pain nerve pain

Interventions

We will study two groups. In the first group patient will be treated using the standard technique of fluoroscopy, in the intervention group patients will be treated using the Evotouch/7starscope. Th

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Correct needle placement (Yes/No) as confirmed with fluoroscopy

Secondary

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

Countries

Netherlands

Contacts

Public ContactMonique van Velzen

Erasmus MC, Universitair Medisch Centrum Rotterdam

m.vanvelzen@erasmusmc.nl010-7040704

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: May 1, 2026