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

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What is this study about?

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.

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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Nantes	Nantes	France

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	04.05.2026

Trial locations

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.

Investigated diseases:

Periarthritis

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 ID:

2026-525317-31-00

Protocol code:

RC25_0554

Trial Phase:

Therapeutic exploratory (Phase II)

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