Cervicobrachial NeuralgiaPhase 3APICALENCT07084285
Cervical Facet Injection of Corticosteroids for the Management of Cervicobrachialgia
A Phase 3 study testing Dexamethasone and Isotonic saline solution in people with Cervicobrachial Neuralgia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervicobrachial Neuralgia
- What is being tested?
- Dexamethasone and Isotonic saline solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2026to May 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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),
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
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
Camille DASTE, MD, PhD, 01 58 41 51 38 ext. +33, camille.daste@aphp.fr
About this study
Official title: Cervical Facet Injection of Corticosteroids for the Management of Cervicobrachialgia : Protocol for a Randomized Pilot Study
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.
Read the detailed description
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.
- Conditions
- Cervicobrachial Neuralgia
- Being tested
- Dexamethasone, Isotonic saline solution
- Keywords
- Neuralgia, cervicobrachialgia, cervicobrachial neuralgia, Foraminal conflict, Posterior intra-articular injection, Cervical spinal injection et corticosteroid
- Medical subject headings
- Brachial Plexus Neuritis, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
A single 4mg (1mL) dexamethasone injection via the posterior intra-articular route, under CT guidance
Isotonic saline solutionOther
1 mL isotonic saline solution, injectable, for a single posterior intra-articular injection, under CT guidance.
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Experimental | A single dexamethasone injection via the posterior intra-articular route Receives: Drug: Dexamethasone |
| Isotonic saline solution | Placebo comparator | A single isotonic saline solution posterior intra-articular injection Receives: Other: Isotonic saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radicular pain (RP) assessed using a simple self-administered numeric rating scale
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.
Measured: Month1
Secondary outcomes (7)
Cervical pain (numeric rating scale, self-administered)
Numeric rating scale, self-administered, ranging from 0 to 100 over the 48 hours preceding Day 15, 1 month, 2 month and 3 month
Measured: Day 15, Month1, Month2, Month3
Neck Disability Index (NDI) score
Self-administered functional scale, ranging from 0 to 50 at Month 1 and Month 3
Measured: Month1 and Month3
Professional status
Self-reported : employed, on sick leave, disabled, unemployed, inactive, retired at Month 1 and Month 3
Measured: Month1 and Month3
Self-administered EQ5D quality of life scale
Measured: Month1 and Month3
Radicular pain (RP) assessed using a simple self-administered numeric rating scale
Simple self-administered numeric rating scale, ranging from 0 (no pain) to 100 (maximum pain), over the 48 hours preceding the visit assessment
Measured: Over the 48 hours preceding the Day 15, the 2-month and the 3-month visits assessment.
The occurrence of adverse events (AEs) and serious adverse events (SAEs)
Measured: Day15, Month1, Month2, Month3
The use of analgesics (levels 1, 2, or 3) since the last visit
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.
Measured: Day 15, Month1, Month2, Month3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study startJan 2026 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervicobrachial NeuralgiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Camille DASTE, MD,PhD, Principal investigator, AP-HP centre , Université Paris-cité
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07084285
- Sponsor's protocol ID
- APHP220671
- Other IDs
- 2024-511790-30
- Acronym
- APICALE
- Status last verified
- Aug 2025
- First submitted
- 16 Jul 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Facet Injection of Corticosteroids for the Management of Cervicobrachialgia : Protocol for a Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT07084285
- Acronym / sponsor ID
- APICALE / APHP220671
- Conditions
- Cervicobrachial Neuralgia
- Keywords
- Neuralgia, cervicobrachialgia, cervicobrachial neuralgia, Foraminal conflict, Posterior intra-articular injection, Cervical spinal injection et corticosteroid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Experimental | Drug: DexamethasoneA single dexamethasone injection via the posterior intra-articular route |
| Isotonic saline solution | Placebo comparator | Other: Isotonic saline solutionA single isotonic saline solution posterior intra-articular injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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,
Key exclusion criteria (13 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasoneA single 4mg (1mL) dexamethasone injection via the posterior intra-articular route, under CT guidance | Drug | Dexamethasone |
| Isotonic saline solution1 mL isotonic saline solution, injectable, for a single posterior intra-articular injection, under CT guidance. | Other | Isotonic saline solution |
Primary outcome
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.
7 secondary outcomes
Cervical pain (numeric rating scale, self-administered)
Time frame: Day 15, Month1, Month2, Month3
Neck Disability Index (NDI) score
Time frame: Month1 and Month3
Professional status
Time frame: Month1 and Month3
Self-administered EQ5D quality of life scale
Time frame: Month1 and Month3
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.
The occurrence of adverse events (AEs) and serious adverse events (SAEs)
Time frame: Day15, Month1, Month2, Month3
The use of analgesics (levels 1, 2, or 3) since the last visit
Time frame: Day 15, Month1, Month2, Month3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Camille DASTE, MD,PhD principal investigator
AP-HP centre , Université Paris-cité
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexamethasone and Isotonic saline solution in people with Cervicobrachial Neuralgia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Camille DASTE, MD,PhD (01 58 41 51 38 ext. +33, camille.daste@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radicular pain (RP) assessed using a simple self-administered numeric rating scale (time frame: Month1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.