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临床试验/CTRI/2024/04/066004
CTRI/2024/04/066004尚未招募不适用

Predictive factors for treatment success of transforaminal epidural steroid injection in lumbosacral disc herniation induced chronic pain.

Lokmanya Tilak Municipal General Hospital and Medical College1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年5月1日最近更新:

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

发起方
Lokmanya Tilak Municipal General Hospital and Medical College
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Preeti Rustagi

Lokmanya Tilak Municipal General Hospital Sion

研究点 (1)

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