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

Recruiting
Conditions
For this study, all patients (18-65 yr.) with 12 or more weeks of radicular pain symptoms, that are eligible for surgery according to a neurosurgeon in the participating hospital, will be asked to participate. Patients are eligible if they already planned to undergo surgery for herniated disc.
Registration Number
NL-OMON27285
Lead Sponsor
eiden University Medical Center, dept of Neurosurgery
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
320
Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:
Lumbar patients:
-Age 18-75
-a unilateral lumbosacral radicular syndrome, with at least the following criteria:
oRadicular incitement: radiating pain from (a part of the) dermatome L4, L5 and/or S1.
oPresent for at least 8 weeks
-MRI verified lumbosacral disc herniation that is corresponding to the side of the symptoms
-Indication for surgery
-Informed consent

Cervical patients:
-Age 18-75
-a unilateral cervical radicular syndrome, with at least the following criteria:
oRadicular incitement: radiating pain from (a part of the) dermatome C45, C56, C67 and/or C7T1.
oPresent for at least 8 weeks
-MRI verified cervical disc herniation that is corresponding to the side of the symptoms
-Indication for surgery
-Informed consent

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:

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
- Epidural steroid injection in the past six months
- Pregnancy
- Inadequate knowledge of the Dutch language

Cervical:
- Previous cervical spinal surgery chemonucleolysis
- 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
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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