Predictive factors for treatment success of transforaminal epidural steroid injection in lumbosacral disc herniation induced chronic pain.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To observe and analyse the effect of patient related factors like age, sex, BMI and co morbid conditions on
研究概览
简要总结
Lumbosacral disc herniation is a common cause of chronic low back pain in
adults. Disc herniation induced pain is triggered by mechanical compression on
the dorsal root or ganglion of the herniated disc material or inflammation induced
by chemokines and enzymes in the disc(1). This pain is usually characterized by
pain arising in the back with or without radiation to lower limb in distribution in
one or more nerves.
Transforaminal epidural steroid injection (TFESI) involves instillation of
corticosteroids around the inflamed nerve root along with low concentration
solution of local anaesthetic . Fluoroscopy guided injection is given through the
intervertebral foramen into the ventral epidural space close to the pathological
site. This helps alleviate the pain by anti-inflammatory and neural membrane
stabilization effects of steroids, increase blood flow to ischemic spinal root
through local anaesthetic agent and removal of cytokines by washout effect of
injection(2,3) . This technique for treatment of lumbosacral radiculopathy is a
cost effective procedure in the majority of cases as compared to other operative
interventions. Complications associated with surgery such as recurrence,
cerebrospinal fluid leakage , haematoma and infections can be avoided . Despite
the established efficacy of TFESI for disc herniation related pain, successful
outcomes may not be obtained in all patients. There could be several variable
factors which might have an impact on treatment outcome in the immediate post
procedure period and later on. These factors could be patient related factors,
clinical or radiological findings. With the need to reduce low value healthcare it
would be helpful to be able to better identify patients who have a reasonable
chance of benefiting from ESI. Therefore this study aims to identify predictive factors for successful treatment outcome 3 months after TFESI in patients with
lumbosacral disc herniation induced pain.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients with traumatic onset of lumbar radiculopathy.
- •Patients with loss of motor power of lower limbs.
- •Local or systemic infection.
- •History of inflammatory rheumatic diseases/ ankylosing spondylitis.
排除标准
- •Patients with traumatic onset of lumbar radiculopathy.
- •Patients with loss of motor power of lower limbs.
- •Local or systemic infection.
- •History of inflammatory rheumatic diseases/ ankylosing spondylitis.
结局指标
主要结局
To observe and analyse the effect of patient related factors like age, sex, BMI and co morbid conditions on
时间窗: 1hour Day 1 1week 1month 3months
treatment success after TFESI .
时间窗: 1hour Day 1 1week 1month 3months
2. To observe and analyse effect of clinical findings like duration of pain, intensity of pain prior to procedure,
时间窗: 1hour Day 1 1week 1month 3months
history of any inciting event or presence of depression, on the treatment success after TFESI
时间窗: 1hour Day 1 1week 1month 3months
3. To observe and analyse effect of Radiological findings on MRI, on treatment success after TFESI
时间窗: 1hour Day 1 1week 1month 3months
次要结局
- To observe & analyse predictive factors related to patient demographics, clinical history, symptoms & radiological findings(follow up period.)
研究者
Dr Preeti Rustagi
Lokmanya Tilak Municipal General Hospital Sion
