Ultrasound-Guided Microendoscopic Versus Fluoroscopic-Guided Lumbar Transforaminal Epidural Steroid Injections

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorAmerican University of Beirut Medical Center

About this trial

The purpose of this study is to compare the Microendoscopic combined with ultrasound technique to the standard routinely used X-ray guided transforaminal steroid injection technique.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 18 and 64 years old of either sex

Disease status of American Society of Anesthesiologists grades I to II

Patients presenting with single-level disc disease and radiculopathy (L2-L3; L3-L4; L4-L5) for steroid injection

Confirmation of herniated disk by CT or MRI

Disqualifiers

Age under 18 or over 64 years old

Pregnant women

Disease status of American Society of Anesthesiologists grades III to IV

Unable to provide an informed consent

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ultrasound microendoscopic technique

    Device

    Ultrasound-guided microendoscopic lumbar transforaminal epidural steroid injection

  • Fluoroscopy

    Radiation

    Fluoroscopy-guided lumbar transforaminal epidural steroid injection.

Treatment groups

124 Participants
are divided into 2 treatment groups
Group A: FluoroscopyPlacebo comparator 1 intervention
Group B: Ultrasound MicroendoscopicExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Intervention success rate

The success of the procedure would be indicated by a questionnaire (yes/no answer). This includes the success of visualization under ultrasound and the insertion of the needle within the target position.

Time frame
During the procedure.

Secondary outcomes

1

Patient satisfaction

Patient satisfaction towards the procedure is indicated on NRS scale (0-10).

Time frame
3 weeks after discharge.
2

NRS pain score

Pain score will be assessed on NRS scale from 0-10.

Time frame
Before procedure, 30 minutes after the procedure, 1 week and 3 weeks after the procedure.
3

Complications

Intravascular injection, intraneural injection, subarachnoid injection and patient discomfort.

Time frame
During procedure.
4

Procedure time

Time taken to complete the procedure.

Time frame
Beginning of procedure till the end.

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: