Effect of Infection, Modic and Inflammation on Clinical Outcomes in Radiculopathy 2

Recruiting

Conditions: disc herniation
hernia
radicular syndrome
10004018
10041543
10009720

Registration Number: NL-OMON52609

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 320

Inclusion Criteria

Lumbar patients: - Age 18-75 - a unilateral lumbosacral radicular syndrome,
with at least the following criteria: - Radicular incitement: radiating pain
from (a part of the) dermatome L4, L5 and/or S1 (obligatory). o Radiculopathy:
abovementioned pain + paresis (MRC grade > 3) of the myotome and/or dysesthesia
in (a part of) the dermatome and/or lowered or no knee reflex or Achilles heel
reflex (not obligatory). o Present for at least 8 weeks - MRI verified
lumbosacral disc herniation that is corresponding to the side of the symptoms
(obligatory) - Indication for surgery (obligatory) - Informed consent
(obligatory), Cervical patients: - Age 18-75 - a unilateral cervical radicular
syndrome, with at least the following criteria: o Radicular incitement:
radiating pain from (a part of the) dermatome C45, C56, C67 and/or C7T1
(obligatory). o Radiculopathy: abovementioned pain + mild paresis (MRC grade >
3) (not obligatory). o Present for at least 8 weeks - MRI verified cervical
disc herniation that is corresponding to the side of the symptoms (obligatory)
- Indication for surgery (obligatory) - Informed consent (obligatory)

Exclusion Criteria

Lumbar: - Previous lumbar spinal surgery or chemonucleolysis - Paresis of MRC <
4 - History of spinal inflammatory disease - Instability that requires surgical
fixation - Active infection at the time of surgery - Usage of Anti-biotics in
the past six months - Pregnancy - Inadequate knowledge of the Dutch language ,
Cervical: - Previous cervical spinal surgery - Paresis of MRC < 4 - Myelopathy
as major complaint - History of spinal inflammatory disease - Instability that
requires surgical fixation - Active infection at the time of surgery - Usage of
Anti-biotics in the past six months - Epidural steroid injection in the past
six months - Pregnancy - Inadequate knowledge of the Dutch language

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p> This study will explore the effects and interactions of bacterial infection,<br /><br>disc inflammation and Modic Changes on the clinical outcome of patients with<br /><br>cervical or lumbar disc herniation. To assess these effects, a mean difference<br /><br>over the course of one-year follow-up of 2-point difference on a 11 point NRS<br /><br>scale will be regarded as clinical relevant and thus used as main study<br /><br>parameter. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. A secondary aim of this study is to assess whether patients that suffer from<br /><br>disc inflammation benefit more from anti-inflammatory drugs than those without<br /><br>inflammation.<br /><br>2. Another secondary aim of this study is to further explore the inflammation<br /><br>process by characterizing different types of macrophages (M1 and M2) and B and<br /><br>T cells.<br /><br>3. At last this study aims to associate the presence of bacterial infection to<br /><br>the presence and type of Modic Changes.</p><br>