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

Withdrawn

• Conditions: Acute Lumbosacral Radicular Syndrome; pain in leg; 10041543

• Registration Number: NL-OMON55127
• Lead Sponsor: Amsterdam UMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 20

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
lidocaine.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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