Effect of Infection, Modic and Inflammation on Clinical Outcomes in Radiculopathy
- 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
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
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
Name Time Method
- Secondary Outcome Measures
Name Time Method