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NCT Number: NCT07084285

Cervical Facet Injection of Corticosteroids for the Management of Cervicobrachialgia

The main objective is 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Assistance Publique - Hôpitaux de Paris, Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis du Pr François Rannou, Hôpital Cochin

Paris, Île-de-France Region, 75014, France

Location contact

Camille DASTE, MD, PhD

CONTACT

[email protected]

01 58 41 51 38 ext. +33

About this study

Cervicobrachial Neuralgia (CBN) is a common condition caused by the compression of a nerve root (C5, C6, C7, or C8) in the cervical spine. In 10% of cases, the duration of symptoms exceeds 3 months, at which point it is considered chronic. Two main etiologies are distinguished :

  • Soft disc herniation,
  • uncodiscarthrotic foraminal stenosis. The pathophysiology involves both mechanical compression and local inflammation. The initial management is typically medical, provided if there are no signs of severity. If medical treatment fails or if signs of severity are present, surgical intervention is required.

The role of corticosteroid injections in the therapeutic strategy in France remains controversial. Literature on the efficacy of cervical spinal injections is heterogeneous and limited, the safety of such injections is debated, and product availability is restricted.

We hypothesize that posterior intra-articular dexamethasone injection would be effective for radicular pain resistant to first-line medical treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years,
  • Unilateral monoradicular cervicobrachial neuralgia (CBN),
  • 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,
  • 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.

Exclusion criteria

  • Inability to speak, read, or write French fluently,
  • 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), 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,
  • Secondary CBN (traumatic, infectious, neoplastic, or inflammatory etiology),
  • Contraindication to fluoroscopy-guided injection (contrast agent allergy, allergy or contraindication to dexamethasone administration),
  • Pregnant women,
  • Ongoing participation in another therapeutic trial or interventional research study,
  • Patient suspected of non-compliance with the study protocol.

Treatment and study plan

Dexamethasone

Drug

A single 4mg (1mL) dexamethasone injection via the posterior intra-articular route, under CT guidance

Isotonic saline solution

Other

1 mL isotonic saline solution, injectable, for a single posterior intra-articular injection, under CT guidance.

Primary outcomes

  1. Radicular pain (RP) assessed using a simple self-administered numeric rating scale

    Time frame: Month1

    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.

Secondary outcomes

  1. Cervical pain (numeric rating scale, self-administered)

    Time frame: Day 15, Month1, Month2, Month3

    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. Neck Disability Index (NDI) score

    Time frame: Month1 and Month3

    Self-administered functional scale, ranging from 0 to 50 at Month 1 and Month 3

  3. Professional status

    Time frame: Month1 and Month3

    Self-reported : employed, on sick leave, disabled, unemployed, inactive, retired at Month 1 and Month 3

  4. Self-administered EQ5D quality of life scale

    Time frame: Month1 and Month3

  5. Radicular pain (RP) assessed using a simple self-administered numeric rating scale

    Time frame: Over the 48 hours preceding the Day 15, the 2-month and the 3-month visits assessment.

    Simple self-administered numeric rating scale, ranging from 0 (no pain) to 100 (maximum pain), over the 48 hours preceding the visit assessment

  6. The occurrence of adverse events (AEs) and serious adverse events (SAEs)

    Time frame: Day15, Month1, Month2, Month3

  7. The use of analgesics (levels 1, 2, or 3) since the last visit

    Time frame: Day 15, Month1, Month2, Month3

    Self-administered 4-level scale (never, several times a month, several times a week, daily) at Day 15, month1, month2 and 3 months post-injection.

Study contacts

Contact information is provided by the study sponsor or research team.

Camille DASTE, MD,PhD

CONTACT

[email protected]

01 58 41 51 38 ext. +33

Laetitia PEAUDECERF, PhD

CONTACT

[email protected]

01 58 41 12 13 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Cervical Facet Injection of Corticosteroids for the Management of Cervicobrachialgia : Protocol for a Randomized Pilot Study

Acronym: APICALE

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 24, 2025
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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