We hypothesize that using the Evotouch/7stascope, ultrasound guided TFEI procedures are non-inferior to the golden standard with fluoroscopy, which means correct placement of the needle within the neuroforamen without intravascular positioning.
ID
Source
Brief title
Condition
- Spinal cord and nerve root disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Correct needle placement (Yes/No) as confirmed with fluoroscopy
Secondary outcome
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.
Background summary
In this exploratory study we will investigate the use of the
Evotouch/7starscope device to perform transforaminal epidural injections (TFEI)
in patients with pain due to lumbar radiculopathy. The advantage of this device
is that optimal needle positioning can be obtained by direct visualisation of
neurovascular structures without the need of fluoroscopy (standard of
practice). Fluoroscopy has several disadvantages including radiation exposure
to patient and medical staff, high cost equipment and the need for specialized
facilities which makes its use impossible in out-patient clinics or at the
bedside.With this study we can investigate whether fluoroscopy is not needed
in the future to perform a TFEI procedure.
Study objective
We hypothesize that using the Evotouch/7stascope, ultrasound guided TFEI
procedures are non-inferior to the golden standard with fluoroscopy, which
means correct placement of the needle within the neuroforamen without
intravascular positioning.
Study design
The study will have an exploratory, non-inferiority design.
Intervention
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. The main objective of the study is to
compare the two methods. For both techniques fluoroscopy will be used to
confirm definite needle positioning.
Study burden and risks
The risks of the study are low. There are risks associated with the epidural
injection such as infection, bleeding, soar skin at puncture place, no
treatment effect en temporary motor loss of the leg due to the local
anesthetic. De different intervention groups do not alter this risk. In every
group definite needle positioning will be checked using fluoroscopy which is
the golden standard. The questionnaire do not form a risk for the patient.
Albinusdreef 2 Albinusdreef 2
Leiden 2300 ZA
NL
Albinusdreef 2 Albinusdreef 2
Leiden 2300 ZA
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL82510.058.22 |