Comparison of Facet Nerve Block Versus Intra-articular Injection in the Diagnosis and Treatment of Lumbar Facet Syndrome
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Pain (VAS score)
研究概览
简要总结
In suspected facet joints pain, it is recommended to perform nerve blocks to establish the diagnosis with positive results being and indicator of successful of most permanent treatment of facet pain by rhizolysis. Nevertheless, the usefulness of intraarticular joint injection for diagnosis and prediction of successful neurolysis have been scarcely studied. The main purpose of this trial is to compare both methods, nerve block and intra articular injection, in diagnosis and treatment of facet joints pain.
详细描述
Facet joint pain is considered as a nonspecific cause of spinal pain with an estimated prevalence of 12-61% of the population. At present, there are no unanimous clinical criteria to achieve and accurate diagnosis and the imaging findings do not show a direct correlation with the clinical symptoms.
Facet syndrome treatment is also controversial and, although most clinical guidelines recommend nerve block as a diagnostic test, followed by neurolysis as therapeutic technique, there are many detractors of this therapeutic sequence.
The confusion is even greater when considering the variability of specialists who perform these techniques, the variability of methods used ranging from blind injections to injections guided by ultrasound, fluoroscopy or CT, or the amount of medication injected.
The investigators have long experience in the percutaneous treatment of pain and in the use of different imaging techniques. Although the investigators objectives are multiple, the main one is to know if there are any difference in the outcome of the facet syndrome treated by intra-articular injections and the block of the medial branch of the dorsal branch of the spinal nerve.
Along with the collaboration of other specialists the investigators want to address secondary objectives such as the usefulness of ultrasound and fluoroscopy in the treatment of facet syndrome and its comparison with those performed under CT guidance that is considered as the standard technique for its greater precision.
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, Outcomes Assessor)
盲法说明
The patients and the evaluator don't know if the injection was performed inside the joint or around the nerve
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1- Lumbar facet syndrome diagnosed by the referring specialist: Rehabilitation, Traumatology or Neurosurgery 2 -Mechanical low back pain that increases with rotation and flexion-extension, without radicular irradiation.
- •3- failure of conservative treatment (pharmacological and physical therapy). 4-Symptoms present more than 3 months
排除标准
- •Previous back surgery and other ablative treatments.
- •Contraindication for the use of corticosteroid or local anesthetic.
- •Uncontrolled acute or chronic medical illness.
- •Pregnancy or lactation.
- •Presence of inflammatory arthropathy or neuropathy.
- •Wounds or skin lesions in the area.
- •Diabetes mellitus.
- •Psychiatric disorders
- •Refusal to participate in the study.
- •Demonstration by imaging techniques of other causes that could justify the symptomatology.
研究组 & 干预措施
FACET JOINT UNDER CT GUIDANCE
Injection of the facet joint under computed tomography guidance
干预措施: FACET JOINT UNDER ULTRASOUND GUIDANCE (Diagnostic Test)
FACET JOINT UNDER CT GUIDANCE
Injection of the facet joint under computed tomography guidance
干预措施: NERVE BLOCK UNDER CT GUIDANCE (Diagnostic Test)
FACET JOINT UNDER CT GUIDANCE
Injection of the facet joint under computed tomography guidance
干预措施: FACET JOINT UNDER FLUOROSCOPY GUIDANCE (Diagnostic Test)
FACET JOINT UNDER CT GUIDANCE
Injection of the facet joint under computed tomography guidance
干预措施: NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE (Diagnostic Test)
FACET JOINT UNDER CT GUIDANCE
Injection of the facet joint under computed tomography guidance
干预措施: NERVE BLOCK UNDER ULTRASOUND GUIDANCE (Diagnostic Test)
NERVE BLOCK UNDER CT GUIDANCE
Injection of the nerve under computed tomography guidance
干预措施: FACET JOINT UNDER CT GUIDANCE (Diagnostic Test)
NERVE BLOCK UNDER CT GUIDANCE
Injection of the nerve under computed tomography guidance
干预措施: FACET JOINT UNDER FLUOROSCOPY GUIDANCE (Diagnostic Test)
NERVE BLOCK UNDER CT GUIDANCE
Injection of the nerve under computed tomography guidance
干预措施: NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE (Diagnostic Test)
NERVE BLOCK UNDER CT GUIDANCE
Injection of the nerve under computed tomography guidance
干预措施: FACET JOINT UNDER ULTRASOUND GUIDANCE (Diagnostic Test)
NERVE BLOCK UNDER CT GUIDANCE
Injection of the nerve under computed tomography guidance
干预措施: NERVE BLOCK UNDER ULTRASOUND GUIDANCE (Diagnostic Test)
FACET JOINT UNDER FLUOROSCOPY GUIDANCE
Injection of the facet joint under fluoroscopy guidance
干预措施: FACET JOINT UNDER CT GUIDANCE (Diagnostic Test)
FACET JOINT UNDER FLUOROSCOPY GUIDANCE
Injection of the facet joint under fluoroscopy guidance
干预措施: NERVE BLOCK UNDER CT GUIDANCE (Diagnostic Test)
FACET JOINT UNDER FLUOROSCOPY GUIDANCE
Injection of the facet joint under fluoroscopy guidance
干预措施: NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE (Diagnostic Test)
FACET JOINT UNDER FLUOROSCOPY GUIDANCE
Injection of the facet joint under fluoroscopy guidance
干预措施: FACET JOINT UNDER ULTRASOUND GUIDANCE (Diagnostic Test)
FACET JOINT UNDER FLUOROSCOPY GUIDANCE
Injection of the facet joint under fluoroscopy guidance
干预措施: NERVE BLOCK UNDER ULTRASOUND GUIDANCE (Diagnostic Test)
FACET JOINT UNDER ULTRASOUND GUIDANCE
Injection of the facet joint under ultrasound guidance
干预措施: FACET JOINT UNDER CT GUIDANCE (Diagnostic Test)
FACET JOINT UNDER ULTRASOUND GUIDANCE
Injection of the facet joint under ultrasound guidance
干预措施: NERVE BLOCK UNDER CT GUIDANCE (Diagnostic Test)
NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE
Injection of the nerve under ultrasound guidance
干预措施: FACET JOINT UNDER CT GUIDANCE (Diagnostic Test)
NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE
Injection of the nerve under ultrasound guidance
干预措施: NERVE BLOCK UNDER CT GUIDANCE (Diagnostic Test)
NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE
Injection of the nerve under ultrasound guidance
干预措施: FACET JOINT UNDER FLUOROSCOPY GUIDANCE (Diagnostic Test)
NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE
Injection of the nerve under ultrasound guidance
干预措施: FACET JOINT UNDER ULTRASOUND GUIDANCE (Diagnostic Test)
NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE
Injection of the nerve under ultrasound guidance
干预措施: NERVE BLOCK UNDER ULTRASOUND GUIDANCE (Diagnostic Test)
FACET JOINT UNDER ULTRASOUND GUIDANCE
Injection of the facet joint under ultrasound guidance
干预措施: FACET JOINT UNDER FLUOROSCOPY GUIDANCE (Diagnostic Test)
FACET JOINT UNDER ULTRASOUND GUIDANCE
Injection of the facet joint under ultrasound guidance
干预措施: NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE (Diagnostic Test)
FACET JOINT UNDER ULTRASOUND GUIDANCE
Injection of the facet joint under ultrasound guidance
干预措施: NERVE BLOCK UNDER ULTRASOUND GUIDANCE (Diagnostic Test)
NERVE BLOCK UNDER ULTRASOUND GUIDANCE
Injection of the nerve under computed ultrasound guidance
干预措施: FACET JOINT UNDER CT GUIDANCE (Diagnostic Test)
NERVE BLOCK UNDER ULTRASOUND GUIDANCE
Injection of the nerve under computed ultrasound guidance
干预措施: NERVE BLOCK UNDER CT GUIDANCE (Diagnostic Test)
NERVE BLOCK UNDER ULTRASOUND GUIDANCE
Injection of the nerve under computed ultrasound guidance
干预措施: FACET JOINT UNDER FLUOROSCOPY GUIDANCE (Diagnostic Test)
NERVE BLOCK UNDER ULTRASOUND GUIDANCE
Injection of the nerve under computed ultrasound guidance
干预措施: NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE (Diagnostic Test)
NERVE BLOCK UNDER ULTRASOUND GUIDANCE
Injection of the nerve under computed ultrasound guidance
干预措施: FACET JOINT UNDER ULTRASOUND GUIDANCE (Diagnostic Test)
结局指标
主要结局
Pain (VAS score)
时间窗: 1 year
score from no pain (0) to maximum pain (10)
次要结局
- Oswestry scale(1 year)
研究者
FERNANDO RUIZ SANTIAGO
PhD, section chief musculoskeletal radiology
Complejo Hospitalario Universitario de Granada