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Study of dexamethasone injections for the management of chronic cervicobrachial neuralgia in adults who have not responded to standard medical treatments

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is being conducted to evaluate the effectiveness of a single injection for the treatment of Cervicobrachial Neuralgia. This condition involves pain that starts in the neck and travels down the arm, often caused by irritation of the nerves. The treatment involves an intra-articular injection, which is a procedure where medicine is delivered directly into a joint space. In this study, participants will receive either dexamethasone, a type of corticosteroid used to reduce inflammation and pain, or a placebo consisting of NaCl 0.9%, which is a saline solution.

The research focuses on managing radicular pain, which is the specific type of shooting or radiating pain that follows the path of a nerve. During the course of the study, individuals will undergo the injection and then be monitored over several months to observe changes in their pain levels and overall ability to perform daily activities. The process includes regular check-ins to track how the medication affects the discomfort in the neck and arms.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>initial injection</b>

    A single intra-articular injection, which is an injection directly into a joint, is performed.

    The injection contains either dexamethasone (a corticosteroid, which is a type of anti-inflammatory medication) at a dose of 4 mg, or a placebo, which is a substance like saline (NaCl 0.9%) that has no active medicine.

  2. Step 2

    <b>follow-up assessments</b>

    At day 15, 1 month, 2 months, and 3 months after the injection, various measurements are taken.

    The level of radicular pain, which is pain that radiates along a nerve, is recorded using a scale from 0 (no pain) to 100 (maximum pain) based on the previous 48 hours.

    cervical pain, which refers to neck pain, is also recorded on a scale from 0 to 100 at the 15-day, 1-month, 2-month, and 3-month marks.

    At 1 month and 3 months, the neck disability index is used to measure how much neck pain affects daily activities, and quality of life is measured using a specific scale.

    At 1 month and 3 months, current professional status, such as being employed or on sick leave, is reported.

    At 15 days, 1 month, 2 months, and 3 months, the frequency of using analgesics (pain-relieving medications) is recorded.

    During every visit, any adverse events, which are unexpected or unwanted medical occurrences, are monitored.

Who can join the trial?

12 criteria

  • You must be 18 years of age or older.
  • If you are of childbearing age, you must use a reliable form of contraception (a method to prevent pregnancy) throughout the entire study.
  • You must not have a biological inflammatory syndrome (a condition where the body's immune system causes swelling or redness), thrombocytopenia (a low level of blood platelets, which help the blood clot), or coagulation disorders (problems with how your blood clots) on the day of the procedure.
  • You must be able to provide written informed consent (a signed document showing you understand and agree to participate) before joining the study.
  • You must have unilateral monoradicular cervicobrachial neuralgia, which means pain felt on only one side of the body traveling from the neck down the arm due to uncarthrosis (wear and tear of the small joints in the spine).
  • Your main symptom must be radicular pain (pain that follows the path of a nerve), with a pain score of at least 40 out of 100 on a Visual Analog Scale (a tool used to measure pain intensity).
  • You must have had an imaging scan, such as a CT scan or an MRI (detailed pictures of the inside of the body), within the last 6 months.
  • The scan must show a foraminal conflict (a situation where a nerve is being pinched or squeezed in the small opening where it exits the spine) at one level, confirmed by a specialist.
  • You must have tried and failed to find relief from medical treatment, including at least one analgesic (pain reliever) and one oral anti-inflammatory (medicine taken by mouth to reduce swelling and pain, such as NSAIDs or corticosteroids) for at least 7 days in a row during the last 3 months.
  • You must have stopped taking oral anti-inflammatory drugs at least 24 hours before being assigned to a study group.
  • Your current episode of pain must have lasted for at least 3 months.
  • Female patients who are not yet in menopause must have a negative pregnancy test on the day of the procedure.

Who cannot join the trial?

19 criteria

  • You are unable to speak, read, or write French fluently.
  • You have an allergy or a medical reason why you cannot receive fluoroscopy-guided injections (this is a procedure where doctors use a special X-ray machine to see inside the body during the injection).
  • You have an allergy or medical reason why you cannot receive contrast agent (a special liquid used to make body structures show up more clearly on X-rays or scans).
  • You have an allergy or medical reason why you cannot receive dexamethasone (a type of medicine used to reduce swelling and inflammation).
  • You have a local or general infection (an area of the body or the whole body is fighting off germs like bacteria or viruses).
  • You have severe coagulation disorders (problems with your blood's ability to clot or thicken to stop bleeding).
  • You have an hypersensitivity (an extreme allergic reaction) to any of the ingredients in the medicine.
  • You are pregnant.
  • You are currently participating in another clinical trial or medical research study.
  • It is suspected that you may not be able to follow the study protocol (the specific set of rules and instructions for the medical study).
  • You are under guardianship, in custody, or deprived of your liberty.
  • You do not have social security coverage.
  • You show severe neurological signs, such as motor deficits (weakness or inability to move muscles properly), pyramidal irritation signs (physical signs indicating issues with the nervous system pathways), or cervical spinal cord edema (swelling of the spinal cord in the neck area) seen on an MRI (a detailed medical scan).
  • Your recent imaging (X-rays or scans) from the last 6 months shows results that do not match the required patterns, such as the absence of nerve compression (where a nerve is being pinched or squeezed).
  • You have had an injection in your cervical spine (the neck area) within the last 3 months.
  • You have foraminal conflict (pinched nerves where they exit the spine) at more than 2 levels.
  • You have had cervical spine surgery within the last 12 months or have a surgery scheduled for this condition within 6 months.
  • You have had a laminectomy (a surgery to remove part of a vertebra to relieve pressure on the spinal cord) or a foraminotomy (a surgery to widen the space where nerves exit the spine) near the area being treated.
  • Your condition is secondary, meaning it was caused by something else like an injury, an infection, a tumor (neoplastic), or inflammation.
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Investigated drugs

Dexamethasone is a steroid medication that is injected directly into the joint to help reduce inflammation and relieve pain in the neck and arm area.

What is already known about the treatment

  • NaCl 0.9%

    This is a sterile saltwater solution used as a placebo in this study, which is typically administered through an injection. It is a well-known substance used widely in medicine to maintain fluid balance and as a liquid base for other drugs. It does not have a specific drug action to treat pain, as it serves as an inactive substance for comparison.

  • Dexamethasone

    This medication is administered as a single injection directly into a joint to reduce inflammation and pain. It is a well-established steroid used in medical practice to manage various inflammatory conditions. It works at a molecular level by blocking certain substances in the body that cause swelling and irritation. This drug belongs to a group of medicines known as corticosteroids.

Investigated diseases

Cervicobrachial Neuralgia - This condition involves pain that radiates from the neck down into the arm. It occurs when a nerve in the cervical spine is irritated or compressed. The pain often follows the path of the nerve, traveling through the shoulder and down the limb. It can manifest as sharp, aching, or burning sensations. As the condition progresses, the discomfort may become more frequent or widespread along the nerve's route.
Trial detailsLast updated 8 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511790-30-00Estimated enrolment70 patientsSponsorAssistance Publique Hopitaux De Paris

sourced from the EU Clinical Trials Register and site verification

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