Retractile CapsulitisPhase 2EBLOUIRNCT07680504
A Pilot Superiority Study Comparing the Efficacy of a Combination of a Glenohumeral Intra-articular Injection With a Suprascapular Nerve Block Versus a Glenohumeral Intra-articular Corticosteroid Injection in Retractile Capsulitis
A Phase 2 study testing Diprostene and Saline (0.9% NaCl) in people with Retractile Capsulitis, run by Nantes University Hospital at 1 site in France.
Trial summary
Drug Trial Single-center Exploratory trial Controlled Randomized Double-blind Prospective Objective is to compare improvements in shoulder function at 3 months between the group receiving an intra-articular injection combined with a suprascapular nerve block and the group receiving an intra-articular injection… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Retractile Capsulitis
- What is being tested?
- Diprostene and Saline (0.9% NaCl)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jun 2026to 25 Jun 2029
- Phase
- Phase 2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with shoulder pain and stiffness that has persisted for at least 2 months but less than 12 months, with a loss of passive range of motion in at least 2 planes (lateral rotation, medial rotation, abduction, forward flexion) of at least 30 degrees compared to the contralateral side
- Patients between the ages of 18 and 65
- Patients enrolled in a social security program
Who cannot join
- - Corticosteroid injection into the affected shoulder < 4 months ago
- History of any surgery on the affected shoulder within the past 12 months
- Patients with a neuromuscular condition (neurological deficit) or shoulder condition (arthropathy) that could interfere with the assessment of the primary endpoint
- Signs or risk of infection (bacterial-like infection and/or fever and/or antibiotic use)
- Poor skin condition of the affected shoulder
- Anticoagulation with VKAs or anti-Xa agents, or active bleeding disorder or one in remission for less than 5 years (malignant hematologic disorders, myelodysplasia, autoimmune thrombocytopenia) or chemotherapy (antiplatelet agents permitted except prasugrel and clopidogrel)*
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- Uncontrolled hypertension,
- Decompensated diabetes or diabetes at risk of decompensation,
- Contraindications to diprosten, Kenacort, or lidocaine
- Psychiatric conditions that may be exacerbated by corticosteroids
- Pregnant or breastfeeding women, or women who refuse to use effective contraception
- Individuals belonging to a vulnerable group as defined by Regulation (EU) No. 536/2014 and French law (See section 4.4 of the protocol) - - Patients unable to comply with the protocol requirements (see Section 4.4 of the protocol)
- Patients participating in another clinical research protocol involving a drug or medical device
- Patients who refuse to participate in the study
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
CHU de Nantes
Nantes
Paul Arnolfo, PH, 02 44 76 81 79, Paul.arnolfo@chu-nantes.fr
About this study
Drug Trial
- Single-center
- Exploratory trial
- Controlled
- Randomized
- Double-blind
- Prospective
Read more
Objective is to compare improvements in shoulder function at 3 months between the group receiving an intra-articular injection combined with a suprascapular nerve block and the group receiving an intra-articular injection combined with a placebo block 19 patients in the Experimental Group (block with corticosteroid and intra-articular injection on Day 0) 19 patients in the Control Group (block with saline and intra-articular injection on Day 0)
- Total duration: 36 months
- Recruitment period: 24 months
- Treatment duration per patient: 2 ultrasound-guided procedures on Day 0
- Follow-up duration per patient: 12 months after the procedure
At J0 : Under ultrasound guidance, inject 2 mL of lidocaine into the notch, then:
- Experimental Group: 8 mL of 1% lidocaine into the notch with 1 mL of betamethasone,
- Control Group: 9 mL of saline into the notch.
During these consultations, M1, M3, M6 et M12 , the following examinations will be performed:
- Clinical examination of the painful shoulder, including measurement of range of motion
- Visual Analog Scale (VAS) for pain
- Quick Dash, OSS, and SPADI self-report questionnaires completed by the patient
- Recording of complications
- Questions about returning to work
- Conditions
- Retractile Capsulitis
- Being tested
- Diprostene, Saline (0.9% NaCl)
- Keywords
- suprascapular nerve block, intra-articular injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiprosteneDrug
Supracapsular nerve block: injection of 10 mL of 1% lidocaine (2 mL along the needle path and 8 mL around the nerve), followed by an injection of 1 mL of DIPROSTENE®.
Intra-articular injection: injection of 2 mL of 1% lidocaine along the needle path and 1 mL of KENACORT RETARD® 40 mg.
Saline (0.9% NaCl)Drug
Suprascapular nerve block: Inject 2 mL of 1% lidocaine along the needle path, followed by 9 mL of normal saline.
Intra-articular injection: injection of 2 mL of 1% lidocaine along the needle path and 1 mL of KENACORT RETARD® 40 mg.
| Study group | Role | What they receive |
|---|---|---|
| Diprostene | Experimental | Supracapsular nerve block: injection of 10 mL of 1% lidocaine (2 mL along the needle path and 8 mL around the nerve), followed by an injection of 1 mL of DIPROSTENE®.
Intra-articular injection: injection of 2 mL of 1% lidocaine along the needle path and 1 mL of KENACORT RETARD® 40 mg. Receives: Drug: Diprostene |
| Saline Solution | Placebo comparator | Suprascapular nerve block: Inject 2 mL of 1% lidocaine along the needle path, followed by 9 mL of normal saline.
Intra-articular injection: injection of 2 mL of 1% lidocaine along the needle path and 1 mL of KENACORT RETARD® 40 mg. Receives: Drug: Saline (0.9% NaCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Quick DASH scores between baseline and M3
Measured: 3 months
Secondary outcomes (7)
1. Functional Assessment
Function using the Quick Dash
Measured: D0, Month 1, Month 3, Month 6, month 12
1. Functional Assessment
Function using the SPADI scores
Measured: D0, Month 1, Month 3, Month 6, month 12
1. Functional Assessment
Function using the OSS
Measured: D0, Month 1, Month 3, Month 6, month 12
Measuring Joint Ranges of Motion with a Goniometer
Measured: Day 0, Month 1, Month 3, Month 6, and Month 12
Pain Assessment
With VAS (Visual Analog Scale) 0-10
Measured: D0, Month 1, Month 3, Month 6, month 12
EVA pain before and after each movement
Measured: Day 0, Month 1, Month 3, Month 6, and Month 12
Return-to-work timelines following the procedure for patients who are employed
Measured: Month 1, Month 3, Month 6, and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start25 Jun 2026 (estimated)
- Primary completion25 Jun 2029 (estimated)
- Study completion25 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retractile CapsulitisStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07680504
- Sponsor's protocol ID
- RC25_0554
- Other IDs
- 2026-525317-31-00
- Acronym
- EBLOUIR
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2026
- Last updated
- 2 Jul 2026
- 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 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Superiority Study Comparing the Efficacy of a Combination of a Glenohumeral Intra-articular Injection With a Suprascapular Nerve Block Versus a Glenohumeral Intra-articular Corticosteroid Injection in Retractile Capsulitis
- ClinicalTrials.gov ID
- NCT07680504
- Acronym / sponsor ID
- EBLOUIR / RC25_0554
- Conditions
- Retractile Capsulitis
- Keywords
- suprascapular nerve block, intra-articular injection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 25 Jun 2026 (estimated)
- Primary completion
- 25 Jun 2029 (estimated)
- Study completion
- 25 Jun 2029 (estimated)
- First posted
- 2 Jul 2026 (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.
Drug Trial
- Single-center
- Exploratory trial
- Controlled
- Randomized
- Double-blind
- Prospective
Objective is to compare improvements in shoulder function at 3 months between the group receiving an intra-articular injection combined with a suprascapular nerve block and the group receiving an intra-articular injection combined with a placebo block 19 patients in the Experimental Group (block with corticosteroid and intra-articular injection on Day 0) 19 patients in the Control Group (block with saline and intra-articular injection on Day 0)
- Total duration: 36 months
- Recruitment period: 24 months
- Treatment duration per patient: 2 ultrasound-guided procedures on Day 0
- Follow-up duration per patient: 12 months after the procedure
At J0 : Under ultrasound guidance, inject 2 mL of lidocaine into the notch, then:
- Experimental Group: 8 mL of 1% lidocaine into the notch with 1 mL of betamethasone,
- Control Group: 9 mL of saline into the notch.
During these consultations, M1, M3, M6 et M12 , the following examinations will be performed:
- Clinical examination of the painful shoulder, including measurement of range of motion
- Visual Analog Scale (VAS) for pain
- Quick Dash, OSS, and SPADI self-report questionnaires completed by the patient
- Recording of complications
- Questions about returning to work
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diprostene | Experimental | Drug: DiprosteneSupracapsular nerve block: injection of 10 mL of 1% lidocaine (2 mL along the needle path and 8 mL around the nerve), followed by an injection of 1 mL of DIPROSTENE®. Intra-articular injection: injection of 2 mL of 1% lidocaine along the needle path and 1 mL of KENACORT RETARD® 40 mg. |
| Saline Solution | Placebo comparator | Drug: Saline (0.9% NaCl)Suprascapular nerve block: Inject 2 mL of 1% lidocaine along the needle path, followed by 9 mL of normal saline. Intra-articular injection: injection of 2 mL of 1% lidocaine along the needle path and 1 mL of KENACORT RETARD® 40 mg. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with shoulder pain and stiffness that has persisted for at least 2 months but less than 12 months, with a loss of passive range of motion in at least 2 planes (lateral rotation, medial rotation, abduction, forward flexion) of at least 30 degrees compared to the contralateral side
- Patients between the ages of 18 and 65
- Patients enrolled in a social security program
Key exclusion criteria (14 listed)
- - Corticosteroid injection into the affected shoulder < 4 months ago
- History of any surgery on the affected shoulder within the past 12 months
- Patients with a neuromuscular condition (neurological deficit) or shoulder condition (arthropathy) that could interfere with the assessment of the primary endpoint
- Signs or risk of infection (bacterial-like infection and/or fever and/or antibiotic use)
- Poor skin condition of the affected shoulder
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 |
|---|---|---|
| DiprosteneSupracapsular nerve block: injection of 10 mL of 1% lidocaine (2 mL along the needle path and 8 mL around the nerve), followed by an injection of 1 mL of DIPROSTENE®. Intra-articular injection: injection of 2 mL of 1% lidocaine along the needle path and 1 mL of KENACORT RETARD® 40 mg. | Drug | Diprostene |
| Saline (0.9% NaCl)Suprascapular nerve block: Inject 2 mL of 1% lidocaine along the needle path, followed by 9 mL of normal saline. Intra-articular injection: injection of 2 mL of 1% lidocaine along the needle path and 1 mL of KENACORT RETARD® 40 mg. | Drug | Saline Solution |
Primary outcome
Difference in Quick DASH scores between baseline and M3
Time frame: 3 months
7 secondary outcomes
1. Functional Assessment
Time frame: D0, Month 1, Month 3, Month 6, month 12
1. Functional Assessment
Time frame: D0, Month 1, Month 3, Month 6, month 12
1. Functional Assessment
Time frame: D0, Month 1, Month 3, Month 6, month 12
Measuring Joint Ranges of Motion with a Goniometer
Time frame: Day 0, Month 1, Month 3, Month 6, and Month 12
Pain Assessment
Time frame: D0, Month 1, Month 3, Month 6, month 12
EVA pain before and after each movement
Time frame: Day 0, Month 1, Month 3, Month 6, and Month 12
Return-to-work timelines following the procedure for patients who are employed
Time frame: Month 1, Month 3, Month 6, and Month 12
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 2 Jul 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Diprostene and Saline (0.9% NaCl) in people with Retractile Capsulitis, run by Nantes University Hospital 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 3 inclusion and 14 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 2 Jul 2026. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Paul ARNOLFO Paul, PH (02 44 76 81 79, Paul.arnolfo@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Quick DASH scores between baseline and M3 (time frame: 3 months). 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 2 Jul 2026.