Relevance of the Combined Extension-rotation-lateral Tilt Maneuver in the Selection of Patients With Chronic Low Back Pain for Neurotnomy Intervention Radiofrequency : Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Brief-Pain Inventory (BPI)
研究概览
简要总结
Chronic low back pain is one of the leading causes of disability associated with significant health care costs. One possible management of chronic low back pain of facet origin is neurotomy-radiofrequency (NT-RF) intervention. Currently, to determine whether a patient is eligible for NT-RF, two positive block tests are required.
Clinical examination with a homolateral extension-rotation-tilt maneuver of the spine (ERI maneuver) would have the potential to identify subjects with pain of facet origin. It could therefore be a simple and effective diagnostic tool in the evaluation of a patient with low back pain and help in the decision whether or not to perform a test block by local infiltration of the zygapophyseal joint prior to an NT-RF procedure.
The purpose of this longitudinal, prospective, observational, single-center study is to evaluate the performance of the combined extension-rotation-lateral tilt maneuver (ERI maneuver) in predicting the response to neurotomy-radiofrequency intervention in patients with chronic low back pain.
The included patients will answer 5 questionnaires, in addition to the usual clinical data:
- Hospital Anxiety and Depression scale (HAD) questionnaire,
- Quality of life questionnaire EQ-5D-5L,
- Brief Pain Inventory - French version: Questionnaire Concis de la Douleur (QCD),
- Functional Impotence Scale for Low Back Pain: The Quebec Back Pain Disability Scale
- Clinical Global Impression of Change (CGI-C)
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted to the chronic pain service at the Calot Institute with chronic low back pain for at least three months, not responding to well-conducted conservative treatment
- •Age 18 - 65 years
- •Patient did not object to the use of their data
- •Patient affiliated to a social security plan
- •Non inclusion Criteria:
- •Patient with a disorder of hemostasis
- •Patient with a history of arthrodesis
- •Patient with radiologically visible root damage
- •Patient with instability of the spine
- •Patient with an abnormality on dorso-lumbar MRI: MODIC 1
- •Patient under legal protection :
- •Person under guardianship,
- •Person under curatorship,
- •Person under legal protection,
- •Person deprived of liberty,
- •Pregnant or breastfeeding woman
排除标准
- 未提供
结局指标
主要结局
Brief-Pain Inventory (BPI)
时间窗: Pre-operative evaluation, at 1 month
Patients will be considered responders if the pain score, estimated by the Brief-Pain Inventory (BPI), is reduced by 50% at 1 month compared to the preoperative workup, and non-responders if the pain score did not reduce sufficiently or if the response to block tests was negative. Each item is rated from 0, no pain, to 10, pain as bad as you can imagine, and contributes with the same weight to the final score, ranging from 0 to 40. The seven sub-items are rated from 0, does not interfere, to 10, completely interferes, and contributes with the same weight to the final score, ranging from 0 to 70.
次要结局
- EQ-5D-5L Questionnaire(Pre-operative evaluation then at 1, 3 and 6 months post intervention)
- Questionnaire Hospital Anxiety and Depression scale (HAD)(Pre-operative evaluation then at 1, 3 and 6 months post intervention)
- The Quebec Back Pain Disability Scale.(Pre-operative evaluation then at 1, 3 and 6 months post intervention)
- Brief-Pain Inventory (BPI)(3 and 6 months post intervention)