APICALE - Cervical facet injection of corticosteroids for the management of cervicobrachialgia : protocol for a randomized pilot study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Assistance Publique Hopitaux De Paris

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Decision date (initial)

2026-03-06

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-511790-30-00

ClinicalTrials.gov

NCT07084285

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy, Safety

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.

Secondary objectives 6

1. Evaluate the short-term (Day 15 and 1 month) and medium-term (2 and 3 months) efficacy of this type of injection on cervical pain
2. Evaluate the short-term (1 month) and medium-term (3 month) efficacy of this type of injection on activity limitations specific to the cervical spine
3. Evaluate the short-term (1 month) and medium-term (3 month) efficacy of this type of injection on quality of life,
4. Evaluate the short-term (Day 15) and medium-term (2 and 3 months) efficacy of this type of injection on radicular pain,
5. Evaluate the safety of this type of injection,
6. Evaluate analgesic use at Day 15,1 month, 2 month and 3 month.

Conditions and MedDRA coding

Cervicobrachial Neuralgia

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 12

1. Age ≥ 18 years,
2. Unilateral monoradicular cervicobrachial neuralgia (CBN),due to uncarthrosis;,
3. Predominant radicular pain, with a Radicular Visual Analog Scale (VAS) score ≥ 40/100,
4. Imaging (CT or preferably MRI) performed within the last 6 months,
5. 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,
6. 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,
7. Discontinuation of oral anti-inflammatory drugs (NSAIDs and/or corticosteroids) 24 hours prior to randomization,
8. Current episode duration ≥ 3 months,
9. Negative pregnancy test on the day of the procedure for premenopausal female patients,
10. Patients of childbearing age must have reliable contraception for the duration of the study;
11. Absence of biological inflammatory syndrome, thrombocytopenia, or coagulation disorders on the day of the procedure,
12. Patient capable of providing written informed consent prior to participating in the study.

Exclusion criteria 13

1. Inability to speak, read, or write French fluently,
2. Patient under guardianship or custody, or deprived of liberty,
3. No affiliation with social security,
4. Neurological signs of severity (clinical motor deficit ≤ 3/5, pyramidal irritation signs, or cervical spinal cord edema on MRI),
5. 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,
6. Recent cervical spine injection (< 3 months),
7. Foraminal conflict at more than 2 levels,
8. 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,
9. Secondary CBN (traumatic, infectious, neoplastic, or inflammatory etiology),
10. 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)
11. Pregnant women,
12. Ongoing participation in another therapeutic trial or interventional research study,
13. Patient suspected of non-compliance with the study protocol

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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.

Secondary endpoints 6

1. 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,
2. 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,
3. The self-administered EQ-5D-5L quality of life scale at Month 1 and Month 3,
4. Radicular pain (numeric rating scale, self-administered, ranging from 0 to 100) over the 48 hours preceding Day 15, month 2, and month 3,
5. The occurrence of adverse events (AEs) and serious adverse events (SAEs) at each visit. Surgical intervention will be considered as a SAE
6. 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.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Assistance Publique Hopitaux De Paris

Sponsor organisation

Assistance Publique Hopitaux De Paris

Address

Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux

City

Paris Cedex 10

Postcode

75475

Country

France

Scientific contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Dr Camille DASTE, Coordinating investigator

Public contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Dr Camille DASTE, Coordinating investigator

Locations

1 EU/EEA country · 4 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 14 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications