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临床试验/NCT04268602
NCT04268602Unknown不适用

The Effect of Intradermal Local Anesthetic Injection on Pain and Functionality in Failed Back Surgery Syndrome

Haydarpasa Numune Training and Research Hospital0 个研究点目标入组 80 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
80
主要终点
Change in OSWESTRY Disability Index scores

研究概览

简要总结

Failed Back Surgery Syndrome is described as chronic pain in the low back and/or legs after a spinal procedure. It is estimated that %10 - 40 of the patients who had spinal surgery will have Failed Back Surgery Syndrome. The aim of this study is to research whether intradermal injection of the local anesthetic on the operation scar area and the area in which pain referred to in patients with Failed Back Surgery Syndrome has effects on pain and functionality or not.

详细描述

The prevalence of low back pain is around 60% - 80% and its the 5th most common disease to seek medical help. 80% of patients who have an acute onset of low back pain whether treated or not relieved on symptoms, while unfortunately 10% of patients' low back pain will worsen end eventually progress to chronic low back pain. With the increase on the number of different techniques on spinal surgery, and an increase in the number of patients who had risk factors undergone spinal surgery caused an increase in the number of patients who had new complaints after surgery. The term Failed Back Surgery Syndrome describes new complaints or not enough ease on the complaints of a patient who had spinal surgery. Due to the variation of the criteria of assessment, it is noted that around 10% -40% of the patients who had spinal surgery will have Failed Back Surgery Syndrome.

Failed Back Surgery Syndrome is commonly described as pain in low back and/or legs with difficulty in daily activities. Pain might be radicular or localized to the low back, it might be mechanic or neuropathic in nature.

Some of the pathologies that cause Failed Back Surgery Syndrome are loss of height on the disc, arthrosis, spinal stenosis caused by the hypertrophy of the facet joints, recurrent disc herniation, arachnoiditis, central stenosis, epidural fibrosis, instability, pseudoarthrosis, and discitis.

Rehabilitation is one of the vital parts of the treatment of Failed Back Surgery Syndrome. After a detailed patient history and a complete physical examination, clinicians should create a rehabilitation program that aims improvements on pain, functionality, quality of life and activities of daily living and is tailored for the patient. It is shown that patients who undergo rehabilitation programs had improvements in physical functionality, posture, and difficulties with walking. Other conservative treatments include cognitive behavioral therapy and noninvasive injection techniques.

Literature shows that multifidus muscle is damaged and atrophied in the patients who had spinal surgery. Also, there is a correlation between functional impairment and atrophy. Usually, the muscles that control flexion and extension of the low back are weak in patients who have low back pain. Extensor muscles, especially the erector spinae muscle group are the posterior stabilisers of the vertebral colon. Loss of endurance and weakness of these muscles and low back pain have a correlation and strengthening these muscles will result in an improvement in low back pain.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Having been diagnosed with failed back surgery syndrome
  • 18-75 years of age
  • visual analogue pain score> 4 to be

排除标准

  • Mental problems
  • Having a disease affecting the central nervous system or peripheral nervous system
  • Fixation operation to the lumbar region
  • Physical therapy in the lumbar region within the last 3 months
  • Injection from the lumbar region in the last 3 months
  • Lidocaine allergy
  • Needle phobia.
  • Wound, infection, allergy, burn-type lesions in the area to be injected
  • Malignity history

结局指标

主要结局

Change in OSWESTRY Disability Index scores

时间窗: baseline, immediately after the intervention, 1 month

Low Back Pain Disability Questionnaire. Minimum-maximum scores are 0-100. Higher scores mean worse outcome

Change in Visual Analog Pain Scale scores

时间窗: baseline, immediately after the intervention, 1 month

Visual analog scale for measurement of pain. Minimum-maximum scores are 0-10. Higher scores mean worse outcome

次要结局

  • Change in Hospital anxiety and depression scores(baseline, immediately after the intervention, 1 month)
  • change in modified schober test measurement(baseline, immediately after the intervention, 1 month)
  • change in Lateral hand to ground test measurement(baseline, immediately after the intervention, 1 month)

研究者

发起方
Haydarpasa Numune Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Duygu Geler Külcü

Clinical Professor Dr, Head of Physical Medicine and Rehabilitation Department

Haydarpasa Numune Training and Research Hospital

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