2024-511790-30-00招募中3 期
APICALE - Cervical facet injection of corticosteroids for the management of cervicobrachialgia : protocol for a randomized pilot study
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Radicular pain (RP) assessed using a simple self-administered numeric rating scale, ranging from 0 (no pain) to 100 (maximum pain), over the 48 hours preceding the 1-month visit assessment compared to the baseline.
研究概览
简要总结
To evaluate the efficacy of a single posterior intra-articular injection of dexamethasone on radicular pain (RP) at 1 month in the treatment of uncomplicated chronic cervicobrachial neuralgia (CBN) in adults, resistant to well-conducted first-line medical treatment.
研究设计
- 分配方式
- Randomized
- 主要目的
- Multicenter, randomized, controlled, two-arms, double-blind, superiority study
- 盲法
- Double (Subject, Carer, Investigator, Monitor)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years,
- •Patients of childbearing age must have reliable contraception for the duration of the study;
- •Absence of biological inflammatory syndrome, thrombocytopenia, or coagulation disorders on the day of the procedure,
- •Patient capable of providing written informed consent prior to participating in the study.
- •Unilateral monoradicular cervicobrachial neuralgia (CBN),due to uncarthrosis;,
- •Predominant radicular pain, with a Radicular Visual Analog Scale (VAS) score ≥ 40/100,
- •Imaging (CT or preferably MRI) performed within the last 6 months,
- •Foraminal conflict at one level on imaging (CT or preferably MRI) performed within the last 6 months, confirmed by a senior investigator trained in the study,
- •Failure of medical treatment that included at least one analgesic (level I to III) and one oral anti-inflammatory (NSAIDs and/or corticosteroids) for at least 7 consecutive days within the last 3 months,
- •Discontinuation of oral anti-inflammatory drugs (NSAIDs and/or corticosteroids) 24 hours prior to randomization,
- •Current episode duration ≥ 3 months,
- •Negative pregnancy test on the day of the procedure for premenopausal female patients,
排除标准
- •Inability to speak, read, or write French fluently,
- •Contraindication to fluoroscopy-guided injection (allergy or contraindication to the administration of contrast agent, allergy or contraindication to the administration of dexamethasone (local or general infection, or suspected infection, severe coagulation disorders) or hypersensitivity to any of the excipients contained in the drug)
- •Pregnant women,
- •Ongoing participation in another therapeutic trial or interventional research study,
- •Patient suspected of non-compliance with the study protocol
- •Patient under guardianship or custody, or deprived of liberty,
- •No affiliation with social security,
- •Neurological signs of severity (clinical motor deficit ≤ 3/5, pyramidal irritation signs, or cervical spinal cord edema on MRI),
- •Non-concordant imaging within the last 6 months (absence of conflict, contralateral conflict, or ipsilateral conflict not immediately adjacent), or showing incompatible anatomy, confirmed by a senior investigator trained in the study,
- •Recent cervical spine injection (< 3 months),
- •Foraminal conflict at more than 2 levels,
- •History of cervical spine surgery within the last 12 months or scheduled surgery in this indication within 6 months, In cases of previous cervical laminectomy, surgery within 2 levels of the infiltrated segment and/or the presence of a foraminotomy associated with the segment will be an absolute contraindication to infiltration,
- •Secondary CBN (traumatic, infectious, neoplastic, or inflammatory etiology),
研究组 & 干预措施
DEXAMETHASONE
Test
干预措施: DEXAMETHASONE (Drug)
NaCl 0.9%
Placebo
干预措施: NaCl 0.9% (Drug)
结局指标
主要结局
Radicular pain (RP) assessed using a simple self-administered numeric rating scale, ranging from 0 (no pain) to 100 (maximum pain), over the 48 hours preceding the 1-month visit assessment compared to the baseline.
Radicular pain (RP) assessed using a simple self-administered numeric rating scale, ranging from 0 (no pain) to 100 (maximum pain), over the 48 hours preceding the 1-month visit assessment compared to the baseline.
次要结局
- Cervical pain (numeric rating scale, self-administered, ranging from 0 to 100) over the 48 hours preceding Day 15, 1 month, 2 month and 3 month,
- The Neck Disability Index (NDI) score (self-administered functional scale, ranging from 0 to 50) at Month 1 and Month 3, and professional status (self-reported: employed, on sick leave, disabled, unemployed, inactive, retired) at Month 1 and Month 3,
- The self-administered EQ-5D-5L quality of life scale at Month 1 and Month 3,
- Radicular pain (numeric rating scale, self-administered, ranging from 0 to 100) over the 48 hours preceding Day 15, month 2, and month 3,
- The occurrence of adverse events (AEs) and serious adverse events (SAEs) at each visit. Surgical intervention will be considered as a SAE
- The use of analgesics (levels 1, 2, or 3) since the last visit, using a self-administered 4-level scale (never, several times a month, several times a week, daily) at Day 15, 1, 2 and 3 months post-injection.
研究者
Dr Camille DASTE, Coordinating investigator
Scientific
Assistance Publique Hopitaux De Paris
研究点 (2)
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