Skip to content

Transforaminal Epidural Steroid Injections for Acute Lumbosacral Radicular Syndrome without prior consultation with a neurologist or diagnostic imaging.

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

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON55127
Enrollment
20
Registered
2022-04-04
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-09

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

Conditions

Acute Lumbosacral Radicular Syndrome pain in leg

Interventions

Treating acute LRS with a TFESI, by straight referral from the GP to the pain physician without prior consultation with a neurologist or diagnostic imaging. The pain physician does an intake to conf

Sponsors

Amsterdam UMC
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
The primary outcome of this study is pain improvement three weeks after TFESI. Pain improvement will be assessed using a 5-point Likert scale previously used to assess decline in pain intensity for patients with acute pain. Patients will be asked whether they experience: (1) no improvement, (2) minimal improvement, (3) much improvement, (4) very much improvement or (5) complete pain relief.

Secondary

MeasureTime frame
Secondary outcomes are intensity of pain measured with the Numeric pain Rating Scale (NRS), severi-ty of pain measured with the Brief Pain Inventory (BPI), quality of life measured with the Short Form 12 Item Health Survey version 2 (SF12v2), anxiety and depression measured with the Hospital Anxiety and Depression Scale (HADS), catastrophizing of pain measured with the Pain Catastrophizing Scale (PCS), effect of treatment measured with a Global Perceived Effect (GPE) scale, and complications.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)