Uppsala Spinal Stenosis Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 156
- 试验地点
- 2
- 主要终点
- Oswestry Disability Index (ODI)
研究概览
简要总结
Lumbar spinal stenosis (LSS) is characterized by low back and leg pain, walking disturbances and sometimes instability, impaired balance and numbness of the lower limbs. This condition is caused by degenerative changes in the lumbar spine including bulging discs, osteophytes from the arthritic facet joints and thickened ligamentum flavum which together cause narrowing of the spinal canal and thus affect the lumbar nerve roots. This diagnosis is attracting more and more interest due to the aging population with increasing demands for physical activity. LSS is the most common indication for spinal surgery. The surgical treatment involves relieving the pressure from the nerve structures in the stenotic segments through a posterior approach. In several studies, surgery has been shown to have better results than the conservative treatment. However, methodological difficulties and a large proportion of cross-over in these studies indicate that there is still uncertainty about whether surgery is generally a better option.
It has been speculated whether the compression of the nerve roots causes in some patients permanent nerve damage with muscle denervation, while in other cases a reinnervation and recovery of the function may occur. Results from neurography and EMG studies have been shown these modalities to have a possible predictive value for the natural process of LSS. If a neurophysiological examination could be able to predict which patients are able to benefit from surgery, many patients could avoid surgery and the risks involved in it.
The aim of this study is primarily to evaluate whether surgery with decompression leads to superior results than the non-surgical treatment with structured physical therapy.
The main secondary aim is to investigate by means of Neurography and EMG, whether the degree of neurological affection caused by nerve compression affects the outcome of surgery for LSS.
详细描述
Background
Lumbar spinal stenosis (LSS) is characterized by low back and leg pain, walking disturbances and sometimes instability, impaired balance and numbness of the lower limbs. This condition is caused by degenerative changes in the lumbar spine including bulging discs, osteophytes from the arthritic facet joints and thickened ligamentum flavum which together cause narrowing of the spinal canal and thus affect the lumbar nerve roots. LSS affects mainly older populations and is unusual under 50 years old. This diagnosis is attracting more and more interest due to the aging population with increasing demands for physical activity. LSS is the most common indication for spinal surgery. The surgical treatment involves relieving the pressure from the nerve structures in the stenotic segments through a posterior approach. The hypertrophic ligaments and parts of the facet joints are removed (i.e., decompression). Adding fusion to the decompression for stabilization of the decompressed segment has not been shown to provide superior results than decompression alone. In several studies, surgery has been shown to have better results than the conservative treatment. However, methodological difficulties and a large proportion of cross-over in these studies indicate that there is still uncertainty about whether surgery is generally a better option.
After decompression, only 60-70% of patients reported to be satisfied with the result and a minor proportion of them experienced even no improvement at all [Strömqvist]. Conservative treatment has shown in some studies to have good results for some patient groups and other studies have shown that the benefit of the surgical treatment decreases over time and that physical exercise may reduce the need for surgery. Moreover, surgery itself has a positive placebo effect that can improve symptoms in some diseases.
It has been speculated whether the compression of the nerve roots causes in some patients permanent nerve damage with muscle denervation, while in other cases a reinnervation and recovery of the function may occur. Results from neurography and EMG studies have been shown these modalities to have a possible predictive value for the natural process of LSS. If a neurophysiological examination could be able to predict which patients are able to benefit from surgery, many patients could avoid surgery and the risks involved in it.
The degeneration of the lumbar spine is progressively impairing the spinal sagittal balance. The need to make extensive correction and fusion in addition to the decompression in order to restore the sagittal balance is debated among spinal surgeons. The experience gained from previous RCTs is that the patients' back pain is reduced by decompression only. Many patients also report that their posture improved after decompression alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 50 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 50-85 years.
- •Clinical symptoms of lumbar spinal stenosis (pseudoclaudication) that indicate and motivate surgery. NRS in lower limbs ≥
- •MRI with finding of LSS at 1-3 lumbar levels. Dural sac area ≤ 75 mm² or degree of stenosis C or D according to Schizas classification.
- •The surgical treatment to be provided is decompression alone.
- •The patient has given oral and written informed consent to the participation in the study.
排除标准
- •Degenerative deformity with Cobb angle > 20°.
- •Spondylolysis.
- •Symptomatic osteoarthritis in the lower limbs that affects and limits their function.
- •Arterial insufficiency (claudication intermittent) .
- •Past lumbar surgery other than disc hernia.
- •Conditions that affect the spine such as ankylosing spondylitis, Diffuse Idiopathic Skeletal Hyperostosis (DISH), spondylodiscitis/infections, malignancy, neurological diseases.
- •Heart and lung diseases that present a significant risk for surgery or make it impossible for the patient to take part in physical training program (ASA>3).
- •Polyneuropathies.
- •Psychological factors that make the patient incapable of inclusion in the study (eg drug addiction, dementia)
结局指标
主要结局
Oswestry Disability Index (ODI)
时间窗: 5 years
Through the Swedish National Spine Registry (SweSpine)
次要结局
- Sensory Amplitude (ENG)(Baseline and 6 months follow-up)
- Denervation Activity (EMG)(Baseline and 6 months follow-up)
- Late Responses (F-wave and H.Reflex)(Baseline and 6 months follow-up)
- Grade of Reinnervation (EMG)(Baseline and 6 months follow-up)
- EQ-5D(Baseline and 6 months, 1, 2, 5 years follow-up)
- Objective Walking Ability(Baseline and 6 months, 1, 2 years follow-up)
- NRS for Low Back and Leg Pain(Baseline and 6 months, 1, 2, 5 years follow-up)
- Subjective Walking Ability(Baseline and 6 months, 1, 2, 5 years follow-up)
- Global Assessment (GA)(Baseline and 6 months, 1, 2, 5 years follow-up)
- Lumbar Lordosis (LL) and Sagittal Vertebral Axis (SVA)(Baseline and 6 months follow-up)
- Patient Satisfaction(Baseline and 6 months, 1, 2, 5 years follow-up)
- Motor Amplitude (ENG)(Baseline and 6 months postoperatively)
- Motor Unit Number Index (MUNIX)(Baseline and 6 months follow-up)
