Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Lidocaine Hydrochloride, Sodium Chloride, and Betamethasone Injections for Adults with Adhesive Capsulitis: A Pilot Efficacy Study

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

The study focuses on adhesive capsulitis, a condition that makes the shoulder joint stiff and painful, limiting everyday activities. Two treatment approaches are being compared: one uses an intra‑articular glenohumeral injection combined with a suprascapular nerve block that contains lidocaine hydrochloride, while the other uses an injection of the steroid medication betamethasone together with a placebo block made of saline solution.

The purpose of the trial is to determine which method provides better shoulder function after three months. Participants receive a single injection session and are then asked to return for check‑ups at one month, three months, six months, and twelve months, during which their shoulder movement, pain level, and ability to resume normal activities are recorded.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and baseline assessment

    On day 0 you are asked to complete the quick dash questionnaire to measure shoulder function.

    You also rate your pain using a visual analogue scale (vas) and a clinician measures shoulder range of motion with a goniometer.

    Your eligibility for the study is confirmed and you are assigned to one of the two treatment groups.

  2. Step 2

    Injection procedure

    A single intra‑articular injection of betamethasone suspension (1 ml) is administered into the shoulder joint.

    In the same visit a suprascapular nerve block is performed.

    If you are in the active‑block group, 10 ml of lidocaine hydrochloride (10 ml) is injected around the nerve.

    If you are in the placebo‑block group, 9 ml of sodium chloride solution (9 ml) is injected in the same manner.

    Both injections are given by infiltration, which means the medication is delivered directly into the tissue.

  3. Step 3

    Month 1 follow‑up

    At month 1 you complete the quick dash questionnaire again and rate pain with the vas.

    The clinician measures shoulder range of motion with a goniometer.

    Any adverse events that occurred since the injection are recorded.

  4. Step 4

    Month 3 follow‑up (primary endpoint)

    At month 3 you repeat the quick dash questionnaire, the vas pain rating, and the range of motion measurement.

    The difference in the quick dash score between day 0 and month 3 is used as the primary outcome of the study.

    Adverse events are again recorded and the time you returned to work, if applicable, is noted.

  5. Step 5

    Month 6 follow‑up

    At month 6 you again complete the quick dash questionnaire, rate pain with the vas, and have shoulder range of motion measured.

    Adverse events and work status are updated.

  6. Step 6

    Month 12 follow‑up

    At month 12 the final assessment includes the quick dash questionnaire, the vas pain rating, and range of motion measurement.

    All adverse events throughout the study period are documented and the final time to return to work is recorded.

Who can join the trial?

4 criteria

  • Be between 18 and 65 years old.
  • Have shoulder stiffness that has lasted at least 2 months but less than 12 months.
  • Experience a loss of passive joint range of motion (the ability to move the shoulder when someone else moves it) of at least 30 degrees in at least two of these directions: lateral rotation (turning the arm outward), medial rotation (turning the arm inward), abduction (lifting the arm away from the body), or antepulsion (moving the arm forward/upward), compared with the opposite shoulder (contralateral side).
  • Be enrolled in a social security system (have valid public health coverage).

Who cannot join the trial?

15 criteria

  • Receiving a corticosteroid (a strong anti‑inflammation medicine) injection in the shoulder you are studying less than 4 months ago.
  • Taking blood‑thinning medicines such as VKA (vitamin K antagonists) or anti‑Xa drugs, or having a bleeding problem that is still active or has been in remission for less than 5 years (including serious blood cancers, bone‑marrow disorders, or immune‑related low platelet counts), or receiving chemotherapy (cancer treatment) or certain antiplatelet medicines (except for prasugrel and clopidogrel).
  • Having high blood pressure that is not controlled by medication.
  • Having diabetes that is not well‑controlled or is at risk of worsening.
  • Being unable to take the study medicines diprosten, Kenacort, or lidocaine because of a medical reason (a contraindication).
  • Being part of a legally defined vulnerable group (as described by EU and French regulations).
  • Being unable to follow the study’s rules and visits.
  • Having a mental health condition that could get worse if given corticosteroids.
  • Being pregnant, breastfeeding, or not using reliable birth control if you are a woman.
  • Already taking part in another clinical study that uses a drug or medical device.
  • Choosing not to take part in this study.
  • Having any shoulder surgery on the affected side within the past 12 months.
  • Having nerve or muscle problems (neuromuscular disorders) or other shoulder diseases (such as joint damage) that could affect the study measurements.
  • Showing signs of infection (like a bacterial infection, fever, or needing antibiotics) or being at risk for infection.
  • Having poor skin condition on the shoulder that is being studied.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Lidocaine Hydrochloride

    is a local anesthetic that is injected near the suprascapular nerve. It works by temporarily numbing the nerve, which reduces pain signals from the shoulder. In this trial the medication is used to perform a suprascapular nerve block, helping to assess how pain relief from the block influences shoulder function when combined with other treatments.

  • Diprosten

    (a suspension that contains betamethasone dipropionate and betamethasone sodium phosphate) is a corticosteroid injection given directly into the shoulder joint. Corticosteroids reduce inflammation and swelling in the joint, which can improve movement and decrease pain in adhesive capsulitis. In the study this medication is used as the intra‑articular injection to test its effectiveness in improving shoulder function.

What is already known about the treatment

  • Lidocaine Hydrochloride

    This medication is given by infiltration, meaning it is injected directly into the shoulder area to numb the tissue. It is a well‑known local anesthetic that is widely used and described in medical literature. It works by temporarily blocking the sodium channels in nerve cells, which stops pain signals from being sent. It belongs to the class of amide‑type local anesthetics.

  • Sodium Chloride

    This solution is also administered by infiltration as an injection, providing a sterile salt water that matches the body’s own fluids. It is a standard medical saline used worldwide and serves as a placebo in this study. Its purpose is to fill the injection space without delivering an active drug, helping to keep the procedure the same for comparison. It is classified as an isotonic electrolyte solution.

  • Betamethasone dipropionate and betamethasone sodium phosphate (Diprostene)

    The drug is supplied as a suspension for injection and is given by intra‑articular infiltration into the shoulder joint. It is an approved corticosteroid that is frequently used to treat joint inflammation and is well documented in the literature. It reduces swelling by binding to glucocorticoid receptors, which lowers the production of inflammatory chemicals. It belongs to the glucocorticoid class of anti‑inflammatory steroids.

Investigated diseases

Adhesive capsulitis - Adhesive capsulitis is a condition that causes stiffness and pain in the shoulder joint. It usually begins with a painful phase where movement is limited and discomfort increases, especially at night. Over weeks to months, the pain may lessen but the shoulder becomes increasingly stiff, making everyday activities difficult. The capsule surrounding the joint thickens and tightens, restricting motion in all directions. The condition often follows a gradual course lasting several months, after which shoulder movement may slowly improve.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2026-525317-31-00Protocol codeRC25_0554Estimated enrolment38 patientsSponsorCentre Hospitalier Universitaire De Nantes

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.