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.
Conditions
Interventions
None listed
Sponsors
Leiden University Medical Center, dept of Neurosurgery
Eligibility
Inclusion criteria
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: o Radicular incitement: radiating pain from (a part of the) dermatome L4, L5 and/or S1. o Present 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: o Radicular incitement: radiating pain from (a part of the) dermatome C45, C56, C67 and/or C7T1. o Present 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Pain The pain experienced by the patients will be measured by two questionnaires to assess back and leg pain: NRS leg pain and NRS back pain. In these questionnaires, the patients will display the amount of pain they have experienced in their back and leg during the week previously to the visit. The pain intensity will be determined on a scale of 0-10. 0 represents ‘no pain’ and 10 represents ‘worst pain imaginable’. Both the NRS back and leg pain score will be measured during every follow-up moment (8, 16, 26, 52 weeks,). Previous test results will not be visible for the patient. 2. Functionality For estimating functionality of the lumbar patient, the Oswestry Disability index (ODI) will be used. This questionnaire contains 10 topics related to the impact of the pain the patient’s life, with 5 grading’s for each topic. The total will give a score between 0 (no disability) and 50 (maximum disability possible), which will be calculated to a 1-100% score. For estimating functionality of the cervical patient, the Neck disability index (NDI) will be used, which is an adjusted version of the ODI focused on neck pain instead of back pain. 3. Modic Changes Type (1,2 or 3) and severity (50%) of Modic Changes will be scored at baseline. 4. Disc inflammation Disc material will be stained for the presence of macrophages, for M1 and M2 macrophages, and for B and T cells. Evaluation will be done through counting cells and subsequenlty catagorizing them. 5. Bacterial infection Bacterial presence in the disc will be verified by a 16s rDNA qPCR analyses for Propionibacterium acnes and staphylococcus epidermidis. 6. Blood samples (from 01-07-2021) In addition to the frozen disc samples, this study will also collect blood samples for two purposes: the first is to assess the general inflammation (BSE, leukocyte differentiation) and vascular status (Cholesterol) and the second purpose is for future analysis, for which a sample will be stored in the freezer. | — |
Secondary
| Measure | Time frame |
|---|---|
| A possible mediator in this study is the amount and type of pain medication that patients take, either in self care or on prescription from the neurosurgeon or GP as part of the usual care. This could potentially alter the inflammation profile (NSAID’s) or could lead to lower perceived pain scores. In addition, it could be that patients with severe inflammation benefit more from anti-inflammatory drugs. Therefore this study will measure participants usage of pain medication as follows: 1. Pharmacological data participants will be asked to fill in a form regarding the frequency and dosage of pain medication and anti-inflammatory drug usage. This form will also be given to the participants during the one-year follow-up at 8, 16, 26 and 52 weeks. 2. Osteoarthritis In order to investigate to what extent Modic Changes are related to clinical features of osteoarthritis, participants will be asked to fill in the Womac questionnaire. The Western Ontario and McMaster Universities Osteoarthritis (Womac) index questionnaire evaluates pain and physical function, con- taining 24 questions about daily functioning and stiffness. The questionnaire will be given to partici- pants at baseline and after one year follow-up. Other study parameters: 1. Demographic data From all patients, general information will be collected: age, gender, BMI, ASA, Diabetes, smoking habits. 2. Clinical data During the intake, the neurosurgeon will assess the duration of the symptoms in weeks. 3. MRI data Nerve root compression(no or mild, moderate, severe) will be scored on MRI. | — |
Contacts
Public ContactGéraldine Lafeber
Leiden University Medical Center
Outcome results
None listed