Short Term Effects of Medial Branch Block vs Para-spinal Injection in Muscle Patients With Non-specific Chronic Low Back Pain
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Change in Chronic Low Back Pain (CLBP) measured by VAS
研究概览
简要总结
This study compares the efficacy of medial branch block (MBB) vs. paravertebral deep intramuscular (PDI) injection for pain relief in chronic low back pain. Based on randomization in first intervention session, one side receives MBB and the other side takes PDI and in second session the pattern reverses.
详细描述
Pain relief following medial branch block (MBB) might be due to facet joints desensitization and/or myofascial trigger points' desensitization. Patients will be randomized to two groups. The first group receives MBB in one side and paravertebral deep intramuscular (PDI) injection in the other side of the back. Next week the pattern of injection will be reversed so the side which had received MBB will take PDI injection and PDI side will take MBB. Second group takes the intervention in reverse order.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CLBP of non-malignant origin fulfilling the following criteria:
- •Pain lasting for at least three months
- •Pain in both the left and right sides of the back
- •Pain below the L2 vertebral body
- •Lumbar spine CT scan or MRI done in the last 2 years
- •Average visual analogue scale (VAS) for pain ≥4/10 on each side for the 3 days
- •Cognitive and physical ability to provide informed consent in English or French
排除标准
- •Neurologic signs or symptoms suggesting nerve root involvement
- •Strictly unilateral Low Back Pain (LBP)
- •CT scan or MRI findings suggestive of pain etiology beyond degenerative spine disease
- •Vascular malformations
- •Infection
- •Fractures
- •DISH (Diffuse idiopathic skeletal hyperostosis)
- •Patients who have received injections of any type or acupuncture therapy to the low back in the last 3 months
- •Prior spine surgery
- •Local or systemic infection
- •Bleeding disorder or the use of anticoagulation medications but for low-dose aspirin
- •Known allergy to amid local anesthetics
- •Active insurance claim (CSST, SAAQ)
- •Uncontrolled psychiatric condition
研究组 & 干预措施
One side of the patient's back
medial branch block (MBB): Using sterile conditions, 25 gauge needles will be placed in the desired position. In its final position for the L3 and L4 vertebrae the needle tip should reside at the junction of the superior articular process and the transverse process. At the L5-S1 level the needle tip should reach the junction between the sacral ala and the superior articular process of S1. Following a negative aspiration 0.5ml of injectate will be injected into each site.
干预措施: Medial branch block in one side (Other)
Other side of the patient's back
These injections will target the deep para-spinal muscles between the spinous process and inter-pedicular line of the L3-5 vertebrae. Under fluoroscopic guidance, a 25-gauge needle will be advanced, directed towards the lamina at the mid-distance between inter-pedicular line and the spinous process of the L3, L4 and L5 vertebrae, until touching the bone. A straight forceps will be attached to the junction of the skin and the needle; the needle will then be withdrawn by 1.4cm, to reside inside the muscle bulk. A five ml syringe diameter will be used to point 1.4 cm withdrawal. Following a negative blood aspiration, each level will be injected with 0.5 ml of the injectate.
干预措施: paravertebral deep intramuscular (PDI) injection (Other)
结局指标
主要结局
Change in Chronic Low Back Pain (CLBP) measured by VAS
时间窗: Seven days
次要结局
未报告次要终点
研究者
Dr. Yoram Shir
Director of the Alan Edwards Pain Management Unit
McGill University Health Centre/Research Institute of the McGill University Health Centre