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APICALE - Cervical facet injection of corticosteroids for the management of cervicobrachialgia : protocol for a randomized pilot study
EU CTIS ID: 2024-511790-30-00
What this study is testing
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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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,
You likely can't join if
- 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,
See the full eligibility criteria
- 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,
- 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),
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.