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| Name | Class |
|---|---|
| Odense University Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| General | Experimental | All subjects will undergo ordinary surgical treatment for their lumbar disc herniation. Experimentally, all subjects participating in the study will receive PET/CT scans and sensory testing as specified below. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PET/CT scan | Diagnostic Test | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| EuroQol-5D 3L | 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. | 1 year |
| Oswestry Disability Index | 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. | 1 year |
| Visual Analogue Scale | Both leg and back. Measure 0-100. 0 being no pain. 100 being worst imaginable pain. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Støttrup, MD | Sygehus Lillebælt | Principal Investigator |
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Following completion of the study, data obtained during the research project will be made available to other researchers using Mendeleys sharing platform
Will be shared late 2020
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 8, 2017 | Mar 27, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007405 | Intervertebral Disc Displacement |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
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| ID | Term |
|---|---|
| D000072078 | Positron Emission Tomography Computed Tomography |
| ID | Term |
|---|---|
| D049268 | Positron-Emission Tomography |
| D014055 | Tomography, Emission-Computed |
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
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| Quantitative Sensory Testing | Diagnostic Test | Patients undergo a battery of quantitative sensory tests prior to surgery, 4-6 weeks after surgery and 6 months after surgery |
|
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014057 | Tomography, X-Ray Computed |
| D064847 | Multimodal Imaging |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D011877 | Radionuclide Imaging |
| D014054 | Tomography |
| D003947 | Diagnostic Techniques, Radioisotope |