Quantitative Sensory Testing and PET/CT Scanning in Assessment of Surgical Outcome for Lumbar Disc Herniation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 主要终点
- EuroQol-5D 3L
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.)
研究组 & 干预措施
General
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.
干预措施: PET/CT scan (Diagnostic Test)
General
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.
干预措施: Quantitative Sensory Testing (Diagnostic Test)
结局指标
主要结局
EuroQol-5D 3L
时间窗: 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
时间窗: 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
时间窗: 1 year
Both leg and back. Measure 0-100. 0 being no pain. 100 being worst imaginable pain.
次要结局
未报告次要终点
研究者
Christian Støttrup
PhD fellow, MD
Spine Centre of Southern Denmark