Prospective Study to Determine Evaluate the Validity and Predictive Ability of Physical Exam Signs for Cervical Radiculopathy to Predict Epidural Steroid Injection (ESI) Treatment Outcomes.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 3
- 主要终点
- Categorical response
研究概览
简要总结
Neck pain is the 4th leading cause of disability in the world, with approximately 50% being neuropathic in nature. Epidural steroid injections (ESI) are one of the most commonly used treatments for cervical radiculopathy. Physical exam signs, including non-organic signs, have been shown to predict outcomes for low back pain treatments, but have yet to be adequately studied for neck pain.
In this prospective, observational study, 72 patients with cervical radiculopathy undergoing an initial ESI for this pain episode will undergo a comprehensive history and physical examination that includes the presence of Spurling test, midline and paraspinal tenderness, 9 non-organic tests in 5 categories, and 3 questionnaires to assess depression, anxiety, sleep, and somatization. The investigators will also evaluate patients' MRI results to determine patients' precise pathology. Patients will then receive interlaminar cervical ESI. The primary outcome measure will be the difference in the proportion of people with a positive categorical outcome, defined as a >/= 2-point decrease in arm pain 4 weeks post-procedure coupled with a score >/= 5 on a 7-point patient global impression of change (PGIC) scale 4 weeks post-treatment, indicating subjective improvement.
The main objectives of this study are to:
- Determine the ability of physical exam, including non-organic signs, to predict ESI outcomes in individuals with cervical radicular pain.
- Determine the prevalence of different non-organic signs, and the association with other factors that may be associated with non-organic illness such as psychopathology and multiple unrelated pain conditions.
详细描述
Seventy-two patients with cervical radiculopathy undergoing an initial ESI for this pain episode will undergo a comprehensive history and physical examination that includes the presence of Spurling test, midline and paraspinal tenderness, 9 non-organic tests in 5 categories, and 3 questionnaires to assess depression, anxiety, sleep, and somatization.
Non-organic signs that the investigators will evaluate are:
-
Tenderness
-
Superficial
-
Non-anatomical (e.g. cervical radicular pain causing tenderness in the arm or mid-back)
-
Sham stimulation
-
Downward pressure on head elicits neck pain
-
With hands clasped behind neck, passive rotation of shoulders elicits neck pain
-
Distraction
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18
- •Cervical radicular pain based on history and physical exam (e.g. pain radiating into one or both extremities, sensory loss, muscle weakness, Spurling's test etc.)
- •Pain duration > 6 weeks
- •Average NRS arm pain score > 4
- •MRI evidence of disc pathology consistent with symptoms
排除标准
- •Untreated coagulopathy
- •Previous spine surgery
- •No MRI study
- •Epidural steroid injection within past 3 years
- •Radiculopathy resulting from tumor or herpes zoster
- •Signs or symptoms or myelopathy or spinal cord compression
- •Allergic reactions to contrast allergy including macrocyclic gadolinium or depo-methylprednisolone
- •Referrals from surgery for diagnostic injections for surgical evaluation
- •Serious medical (e.g. congestive heart failure) condition that might preclude optimal outcome
- •Pregnancy
结局指标
主要结局
Categorical response
时间窗: 4 weeks
Positive response is defined as a \>/= 2-point reduction in average arm pain coupled with \>/= 5/7 score on patient global impression of change. Anything else is a negative response.
次要结局
- Worst neck pain(12 weeks)
- Neck disability index (NDI) score(12 weeks)
- Somatic Symptom Scale (SS-8) score(12 weeks)
- Categorical response(12 weeks)
- Average arm pain(12 weeks)
- Athens Insomnia Scale (AIS) score(12 weeks)
- Hospital Anxiety and Depression Scale (HADS)(12 weeks)
- Worst arm pain(12 weeks)
- Average neck pain(12 weeks)
- Patient Global Impression of Change (PGIC) scale(12 weeks)
