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Clinical Trials/NL-OMON55127
NL-OMON55127WithdrawnNot Applicable

Transforaminal Epidural Steroid Injections for Acute Lumbosacral Radicular Syndrome without prior consultation with a neurologist or diagnostic imaging. - Fast-track TFESI for LRS

Amsterdam UMC0 sites20 target enrollmentStarted: TBDLast updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Sponsor
Enrollment
20

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
18 to 64 (—)

Inclusion Criteria

  • - Male/female, 20 to 50 years
  • - Patients with a first time presentation of aLRS in the involved dermatome
  • - Pain radiating in the leg, following spinal segments L4, L5 or S1
  • - Predominantly leg pain
  • - Pain score of NRS *6
  • - The symptoms are present for less than six months
  • - There is no indication for immediate referral to a neurologist or
  • neurosurgeon, according to the Dutch lumbosacral radicular syndrome guideline.
  • - Subject is able and willing to provide informed consent
  • - Subject is able and willing to comply with the protocol and follow-up schedule
  • The current guideline from the Dutch Spine Society provides extensive screening
  • methods to diag-nose aLRS. For instance, prominent leg pain, typical
  • dermatomeric pain and increase in radiating pain at pressure-increasing moments
  • have shown to be strong predictors of nerve root compression.1 If anamnesis
  • shows there is a chance of underlying suffering (exclusion criteria), patients
  • are referred to a neurologist, conform the guideline.

Exclusion Criteria

  • - History of back surgery
  • - History of LRS with radiation that follows the same side and segmental pattern
  • - Pain present since recent trauma
  • - Unexplained weight loss
  • - Severe back pain with fever
  • - Predominantly back pain during the night
  • - Previous Borrelia Burgdorferi infection
  • - Patient has a (history of) malignancy
  • - Bilateral limb pain
  • - Predominantly back pain of *50%
  • - Pain score of NRS <6
  • - Cauda equina syndrome or acute severe paresis or progressive paresis (within
  • a few days)
  • - History of coagulation disorders
  • - Pregnancy or breastfeeding
  • - Immunocompromised
  • - Previous adverse reactions to contrast agents, methylprednisolone or

Investigators

Sponsor
Amsterdam UMC

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