Lumbar Disc Herniation, Radiculopathy Lumbar
Conditions
Keywords
PET/CT
Brief summary
Patients with lumbar disc herniation suffer from pain and morbidity. Surgical intervention can be a quick and effective relief, however some individuals experience less favorable outcome. This study tries to investigate and test the differences in pain perception and pain modulation between individuals. Using PET/CT scans the investigators try to visualize pain perception and -modulation in the CNS. This is subsequently correlated with a battery of pain tests and the surgical outcome of disc herniation surgery.
Interventions
DIAGNOSTIC_TESTPET/CT scan
Patient receive a PET/CT scan of their cerebrum and lumbar spine prior to surgery, 4-6 weeks after surgery and 6 months after surgery
DIAGNOSTIC_TESTQuantitative Sensory Testing
Patients undergo a battery of quantitative sensory tests prior to surgery, 4-6 weeks after surgery and 6 months after surgery
Sponsors
Odense University Hospital
Spine Centre of Southern Denmark
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Informed consent * Clinical and radiological indication for LDH surgery, assessed by an experienced spinal surgeon * Age 40-65 years * Able to comply with regulations regarding medicine consumption (stated below)
Exclusion criteria
* History of previous spine surgery * General contra-indication for spine surgery * Greatly reduced kidney function * Diagnosis of psychiatric disorder * Current malignant disease * History of radiation therapy * Current chemotherapy * History of spinal fracture * Hematologic disease * Current pregnancy or breast-feeding * Chronic, generalized connective tissue disorders or chronic, non-specific pain disorders (fibromyalgia, whiplash (WAD I-V), etc.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale | 1 year | Both leg and back. Measure 0-100. 0 being no pain. 100 being worst imaginable pain. |
| EuroQol-5D 3L | 1 year | The 3-level version of EQ-5D (EQ-5D-3L) was introduced in 1990 by the EuroQol Group. The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement. |
| Oswestry Disability Index | 1 year | The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools. 0% to 20%: minimal disability: The patient can cope with most living activities. 21%-40%: moderate disability: The patient experiences more pain and difficulty with sitting, lifting and standing. Travel and social life are more difficult, and they may be disabled from work. 41%-60%: severe disability: Pain remains the main problem in this group but activities of daily living is affected. These patients require a detailed investigation. 61%-80%: crippled: Back pain impinges on all aspects of the patient's life. 81%-100%: These patients are either bed-bound or exaggerating their symptoms. |
Outcome results
None listed