Quantitative Sensory Testing and PET/CT Scanning in Assessment of Surgical Outcome for Lumbar Disc Herniation
- Conditions
- Lumbar Disc HerniationRadiculopathy Lumbar
- Registration Number
- NCT03894943
- Lead Sponsor
- Spine Centre of Southern Denmark
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 61
- 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)
- 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.)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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.Visual Analogue Scale 1 year Both leg and back.
Measure 0-100. 0 being no pain. 100 being worst imaginable pain.
- Secondary Outcome Measures
Name Time Method