The Evaluation of Effect of the Cervical İnterlaminar Epidural Steroid İnjection on Quality of Life, Neuropathic Pain and Disability in Patients With Cervical Radiculopathy
试验速览
- 阶段
- 不适用
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Pain relief
研究概览
简要总结
To evaluate the effect of cervical interlaminar epidural steroid injections on the neuropathic pain, quality of life and disability patients with cervical radiculopathy. After the clinical and MRG evaluations of patients with neck and arm pain, injection was given to eligible patients.
Patients undergone the procedure were evaluated before and after injection for neuropathic pain, quality of life and disability.
详细描述
Neck and arm pain related to cervical radiculopathy is the second indication for epidural steroid injections after lumbar radiculopathy in the many a pain clinic. In this procedure corticosteroids and local anesthetics were given to the epidural space with fluoroscopy-guided special techniques. The underlying mechanism of action of these epidurally administered medications is not clear and ıt is believed to be due to anti-inflammatory properties of corticosteroids. In addition local anesthetics is thought to be as effective as corticosteroids in spinal pain of various origin. So far, many studies have shown the efficacy of these injections in acute/chronic pain of cervical radiculopathy. Although mixed pain is seen in most of patients, the relationship between pain pattern and treatment response is unclear. This study aims to evaluate the treatment responses of the patients who were diagnosed with neuropathic pain and the patients who weren't by means of LANSS. It is also intended to serach whether the presence of neuropathic pain will help to predict the treatment response or not. In this regard, the patients were evaluated with LANSS, SF-12 and neck pain and disability scale before the procedure. Categorized as the patients with neuropathic pain and the patients without, their treatment responses were compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 否
入选标准
- •Neck pain and / or unilateral arm pain for at least 3 months
- •Inadequate response to conservative treatment methods
- •Visual analog scale>5
- •Treatment of neuropathic pain:
- •Patients who received adequate treatment for a sufficient period of time (Gabapentine ( ≥4 wk ve ≥ 1200 mg) or Pregabaline ( ≥4 wk ve ≥ 300mg )) and did not respond adequately
排除标准
- •Cervical epidural injection history applied in the last 3 months
- •Presence of systemic and / or local infection
- •Bleeding diathesis
- •Pregnancy
- •Presence of a history of allergy to contrast agent and local anesthetic agent
- •Systemic inflammatory disease ( rheumatoid arthritis, SLE..)
- •Presence of malignancy
- •Presence of polyneuropathy, multiple sclerosis or demyelinating nervous system diseases
- •Patients with a history of surgical operations for cervical disc hernia and / or spinal stenosis
- •Patients with myelomalacia due to spinal cord compression
研究组 & 干预措施
Cervical interlaminar epidural steroid injecion
Floroscopy-guided cervical interlaminar epidural steroid injecion will be applied to the patients with cervical radiculopathy related neck and arm pain
干预措施: Combination Product: triamcinolone and saline (Drug)
结局指标
主要结局
Pain relief
时间窗: 6th month after procedure (T3)
Pain will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from "0 cm" (no discomfort) to "10 cm" (worst imaginable) The primary outcome measure is reduction in initial VAS , treatment success was considered a 50% or more reduction in VAS point
Pain classification-The leeds assesment of neuropathic signs&symptoms (LANSS)
时间窗: 6th month after procedure (T3)
LANSS is an assessment tool that used to analyze and classify pain. The scale comprises of a 7-item pain scale, including the sensory descriptors and items for sensory examination.According to various research reports, these LANSS tests correctly classified the patients as suffering from nociceptive and neuropathic pain, in four out of every five patients experiencing chronic pain. The validity and reliability of the questionnaire in Turkish were conducted by Yucel et al.
Pain relief
时间窗: before treatment(T0)
Pain will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from "0 cm" (no discomfort) to "10 cm" (worst imaginable) The primary outcome measure is reduction in initial VAS , treatment success was considered a 50% or more reduction in VAS point
Pain relief
时间窗: 1th month after procedure (T1)
Pain will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from "0 cm" (no discomfort) to "10 cm" (worst imaginable) The primary outcome measure is reduction in initial VAS , treatment success was considered a 50% or more reduction in VAS point
Pain relief
时间窗: 3th month after procedure (T2)
Pain will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from "0 cm" (no discomfort) to "10 cm" (worst imaginable) The primary outcome measure is reduction in initial VAS , treatment success was considered a 50% or more reduction in VAS point
Pain classification-The leeds assesment of neuropathic signs&symptoms (LANSS)
时间窗: before treatment(T0)
LANSS is an assessment tool that used to analyze and classify pain. The scale comprises of a 7-item pain scale, including the sensory descriptors and items for sensory examination.According to various research reports, these LANSS tests correctly classified the patients as suffering from nociceptive and neuropathic pain, in four out of every five patients experiencing chronic pain. The validity and reliability of the questionnaire in Turkish were conducted by Yucel et al.
Pain classification-The leeds assesment of neuropathic signs&symptoms (LANSS)
时间窗: 1th month after procedure (T1)
LANSS is an assessment tool that used to analyze and classify pain. The scale comprises of a 7-item pain scale, including the sensory descriptors and items for sensory examination.According to various research reports, these LANSS tests correctly classified the patients as suffering from nociceptive and neuropathic pain, in four out of every five patients experiencing chronic pain. The validity and reliability of the questionnaire in Turkish were conducted by Yucel et al.
Pain classification-The leeds assesment of neuropathic signs&symptoms (LANSS)
时间窗: 3th month after procedure (T2)
LANSS is an assessment tool that used to analyze and classify pain. The scale comprises of a 7-item pain scale, including the sensory descriptors and items for sensory examination.According to various research reports, these LANSS tests correctly classified the patients as suffering from nociceptive and neuropathic pain, in four out of every five patients experiencing chronic pain. The validity and reliability of the questionnaire in Turkish were conducted by Yucel et al.
次要结局
- Disability-Neck pain and disability scale (NPAD)(6th month after procedure (T3))
- Quality of life-Short form-12(6th month after procedure (T3))
- cervical range of motion (ROM) will be evaluated with a goniometer(6th month after procedure (T3))
- upper extremity motor exam(6th month after procedure (T3))
- Quality of life-Short form-12(3th month after procedure (T2))
- Quality of life-Short form-12(before treatment(T0))
- Quality of life-Short form-12(1th month after procedure (T1))
- Disability-Neck pain and disability scale (NPAD)(before treatment(T0))
- Disability-Neck pain and disability scale (NPAD)(1th month after procedure (T1))
- Disability-Neck pain and disability scale (NPAD)(3th month after procedure (T2))
- cervical range of motion (ROM) will be evaluated with a goniometer(before treatment(T0))
- cervical range of motion (ROM) will be evaluated with a goniometer(1th month after procedure (T1))
- cervical range of motion (ROM) will be evaluated with a goniometer(3th month after procedure (T2))
- upper extremity motor exam(before treatment(T0))
- upper extremity motor exam(1th month after procedure (T1))
- upper extremity motor exam(3th month after procedure (T2))