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临床试验/NCT05636917
NCT05636917招募中不适用

Study of the Diagnostic Accuracy of the Slump and Straight Leg Raise Neurodynamic Tests in Patients With Clinical Suspicion of Lumbar Radiculopathy

Universidad de Zaragoza1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
1
主要终点
Disc injuries

研究概览

简要总结

Lumbar radiculopathy is a relevant cause of disability and morbidity, accounting for between 23 and 57% of the cases of patients with low back pain and representing a significant expense due to the sick leave and health care that may be required.

Nuclear magnetic resonance and electromyography are the most commonly used tests for the diagnosis of the pathology.

Neurodynamic tests represent a sequence of structured movements with the purpose of increasing the mechanical stress of the neural tissue. These tests are currently an important aspect of the physical examination of the patient when there is suspicion of neural involvement, allowing the physiological and mechanical capacities of the nerve to be evaluated.

The Slump and Straight Leg Raise neurodynamic tests are the two best known tests for assessing the mechanosensitivity of the sciatic nerve and its component roots.

The hypothesis of this observational study is that the straight leg raising and Slump neurodynamic tests with precise diagnostic criteria are valid tools for the diagnosis of lumbar radiculopathy.

详细描述

Background and justification Background Lumbar radiculopathy is a relevant cause of disability and morbidity and may constitute between 23 and 57% of the cases of patients with low back pain and represents an important expense due to the sick leave and health care that may be required. It is a pathological process that can affect different lumbar roots and can cause radiating symptoms that manifest in the territory of the lower limb that includes this root. Some studies estimate the prevalence in the general population to be between 1.6 and 13.4%, with the predominant age range being between 45 and 64 years of age and affecting men more frequently than women.

Protrusion or migration of the lumbar intervertebral disc is the most common cause of nerve root irritation and subsequent radiculopathy. Disc herniation is define as a localised displacement of disc material beyond the normal margins of the intervertebral disc space resulting in pain, weakness or numbness in a myotomal or dermatomal distribution.

In clinical practice, the diagnosis of lumbar radiculopathy involves the use of several tools and procedures including neuropathic pain screening, clinical neurological examination, electro-diagnostic, nerve root block and radiological imaging. The gold standard for the diagnosis of lumbar disc herniation is surgery; however, when assessing the validity of subjective tests or physical examination findings, the use of cross-sectional imaging as a gold standard may be considered an acceptable substitute, always bearing in mind that the results of any imaging test should be closely correlated with the clinical examination.

Many clinical guidelines advise muscle strength testing, sensory testing and different neurodynamic tests for the diagnosis of lumbar disc herniation with radiculopathy.

Neurodynamic tests represent a structured sequence of movements aimed at increasing the mechanical stress on the neural tissue, and are now an important aspect of the physical examination of the patient when there is suspicion of neural involvement, allowing assessment of the physiological and mechanical capabilities of the nerve. These neurodynamic tests include the mechanism of structural differentiation that allows a specific assessment of neural tissue and makes it possible to rule out a musculoskeletal origin of the patient's symptoms.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

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

  • Being between 18 and 75 years of age.
  • Having symptoms compatible with lumbar radiculopathy at the time of the study. Intermittent or constant pain in the lumbar area or radiating to a distal extremity, to the gluteal fold; or distribution of pain in all or part of the dermatomic area of one or two adjacent lumbosacral nerve roots (L3-S2 segments).
  • Have undergone or are awaiting MRI of the lumbar region.
  • Have been referred for an electrophysiological study of the sciatic nerve or its branches.
  • Have sufficient comprehension and communication skills to be able to communicate their symptoms and their characteristics.
  • Accept and give their consent to participate voluntarily in the study and provide their clinical data anonymously.

排除标准

  • Having radiological tests with a diagnosis of spondylolysis and/or spondylolisthesis in the lumbar region.
  • Having been diagnosed with diabetes, thyroid dysfunction, rheumatoid arthritis, heart and/or lung disease, alcoholism, HIV+, herpes zoster infection, multiple sclerosis, hereditary neuropathy or any known neurodegenerative disease and/or pregnancy.
  • Have undergone lumbar surgery and/or transforaminal epidural steroid injection within the previous 12 months.
  • Have received physiotherapeutic neurodynamic treatment.
  • Have suffered a fracture of any vertebrae of the spine.
  • Have been diagnosed with other compressive causes or causes that produce irritation of the lumbar roots or stenosis of the spinal canal.
  • Be unable or have contraindications to adopt the supine decubitus and/or seated position with lumbar, dorsal and cervical flexion or to maintain the position for the duration of the tests.
  • Present any physical contraindication (red flags) such as neoplastic processes, serious infections; or psychological contraindication (yellow flags) such as psychiatric pathologies that could influence the state of the subjects or the results of the study.
  • That the MRI is performed more than 12 months after the clinical examination.
  • Failure to complete all the assessment phases of the study.

结局指标

主要结局

Disc injuries

时间窗: Through study completion, an average of 1 year

Quantify by nuclear magnetic resonance whether and to what extent the disc is damaged.

DN4 Neuropathic pain questionnaire.

时间窗: Through study completion, an average of 1 year

The DN4 questionnaire consists of a total of 10 items grouped in 4 sections. The first seven items are related to the quality of pain (burning, painful, cold, electric shocks) and its association to abnormal sensations (tingling, pins and needles, numbness, itching).The other 3 items are related to neurological examination in the painful area (touch hypoesthesia, pinprick hypoesthesia, tactile allodynia). A score of 1 is given to each positive item and a score of 0 to each negative item. The total score is calculated as the sum of all 10 items, and the cut-off value for the diagnosis of neuropathic pain is a total score of 4/10.

Straight leg raise test

时间窗: Through study completion, an average of 1 year

Straight leg raise test is performed to assess the mechanosensitivity of the nerve.

Nerve conduction tests. Electromyography.

时间窗: Through study completion, an average of 1 year

Electromyography are performed to assess nerve root status. The electromyography result shall be classified according to the specialist's report. The items are "Mild radiculopathy" and "Severe radiculopathy"

Pain scales

时间窗: Through study completion, an average of 1 year

The Visual Analogue Scale is used to assess the patient's level of impairment (VAS). Values from 0 to 10. 0 no pain, 10 maximum pain.

The Oswestry scale

时间窗: Through study completion, an average of 1 year

The Oswestry scale is used to assess the patient's level of impairment. Shows the percentage of dysfunction. The total score is expressed as a percentage (from 0 to 100 %). Higher values describe greater functional limitation. Between 0-20 %: minimal functional limitation; 20-40 %: moderate; 40-60 %: severe; 60-80 %: disability; and above 80 %: maximum functional limitation.

Slump test

时间窗: Through study completion, an average of 1 year

Slump test is performed to assess the mechanosensitivity of the nerve.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alberto Montaner Cuello

Principal Investigator

Universidad de Zaragoza

研究点 (1)

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