Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Authorised, recruitment pending
Participants planned
38
Countries
1
Sites
1
Retractile Capsulitis
Compare the improvement in shoulder function at 3 months between the intra-articular injection group combined with a suprascapular nerve block and the intra-articular injection group combined with a placebo block.
Key facts
- Sponsor
- Centre Hospitalier Universitaire De Nantes
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05]
- Decision date (initial)
- 2026-05-29
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- CHU de Nantes - Appel d'Offre Interne
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
Compare the improvement in shoulder function at 3 months between the intra-articular injection group combined with a suprascapular nerve block and the intra-articular injection group combined with a placebo block.
Secondary objectives 5
- Comparison of functional outcomes between the two groups up to 12 months
- Comparison of pain progression between the two groups over a 12-month period
- Comparison of joint range of motion between the two groups up to 12 months
- Assessment of tolerance of movements
- Assessment of return to work.
Conditions and MedDRA coding
Retractile Capsulitis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10017391 | Frozen shoulder | 10028395 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Overall Trial - Overall Trial
- Pilot study,
- Single-center,
- Prospective,
- Double-blind (patient/evaluator)
- Superiority study,
- Randomized into 2 parallel groups (1:1 ratio)
o Experimental group: suprascapular nerve block (with lidocaine and betamethasone) + intra-articular injection
o Control group: suprascapular nerve block (with saline solution) + intra-articular injection
|
Randomised Controlled | Double | [{"id":184302,"code":2,"name":"Investigator"},{"id":184301,"code":1,"name":"Subject"}] | Experimental group: suprascapular nerve block (lidocaine and betamethasone) + intra-articular injection Control group: injection of saline solution around the suprascapular nerve (placebo) + intra-articular injection |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Patients with shoulder stiffness lasting at least 2 months and less than 12 months, with a loss of passive joint range of motion in at least 2 planes (lateral rotation, medial rotation, abduction, antepulsion) of at least 30 degrees compared to the contralateral side
- Patients aged between 18 and 65 years
- Patients affiliated with a social security system
Exclusion criteria 15
- Corticosteroid injection in the affected shoulder < 4 months
- Psychiatric condition likely to be decompensated by corticosteroids
- Women who are pregnant or breastfeeding or who refuse effective contraception
- Patients participating in another clinical research protocol involving a drug or medical device
- Patients refusing to participate in the study
- History of any surgery on the affected shoulder within the last 12 months
- Patients with neuromuscular disorders (neurological deficits) or shoulder disorders (arthropathy) that could interfere with the assessment of the primary endpoint
- Signs or risks of infection (bacterial infection and/or fever and/or antibiotic use)
- Poor skin condition of the pathological shoulder
- - Anticoagulation with VKA or anti-Xa, or bleeding disorder currently active or in remission for less than 5 years (malignant blood disorders, myelodysplasia, autoimmune thrombocytopenia) or chemotherapy (antiplatelet agents authorized except prasugrel and clopidogrel)*
- Uncontrolled high blood pressure,
- Uncontrolled diabetes or at risk of decompensation,
- Contraindications for diprosten, Kenacort, or lidocaine
- Persons belonging to a vulnerable group as defined by Regulation (EU) No. 536/2014 and French law
- Patients who are unable to comply with the protocol requirements
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary endpoint is the difference in Quick DASH scores between enrollment and M3.
Secondary endpoints 5
- Assessment of function using a Quick Dash score on D0, M1, M3, M6, and M12 and measurement of the area under the curve.
- Assessment of pain: VAS on D0, M1, M3, M6, and M12
- Measurement of joint range of motion with a goniometer on D0, M1, M3, M6, and M12.
- EVA pain before and after the procedure; collection of adverse events at Day 0, Month 1, Month 3, Month 6, and Month 12.
- Time to return to work after the procedure for patients who were employed at Day 0, 1 month, 3 months, 6 months, and 12 months.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
DIPROSTENE, suspension injectable en seringue pré-remplie
PRD8891787 · Product
- Active substance
- Betamethasone Dipropionate
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INFILTRATION
- Max daily dose
- 1 ml millilitre(s)
- Max total dose
- 1 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB01 — BETAMETHASONE
- Marketing authorisation
- 34009 320 050 9 3
- MA holder
- ORGANON FRANCE
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB88133 · Substance
- Active substance
- Lidocaine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INFILTRATION
- Max daily dose
- 10 ml millilitre(s)
- Max total dose
- 10 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
SUB12581MIG · Substance
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INFILTRATION
- Max daily dose
- 9 ml millilitre(s)
- Max total dose
- 9 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire De Nantes
- Sponsor organisation
- Centre Hospitalier Universitaire De Nantes
- Address
- 5 Allee De L Ile Gloriette, Cs 69301 Cs 69301
- City
- Nantes Cedex 1
- Postcode
- 44093
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire De Nantes
- Contact name
- Arnolfo
Public contact point
- Organisation
- Centre Hospitalier Universitaire De Nantes
- Contact name
- Arnolfo
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 38 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Universitaire De Nantes
Service de Rhumatologie, 5 Allee De L Ile Gloriette, Cs 69301, Nantes Cedex 1
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2026-525317-31-00_FP | 1.3 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults FP | 1.3 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Diprostene | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Lidocaine | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis uk_2026-525317-31-00 | 1.2 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-02-06 | France | Acceptable 2026-05-26
|
2026-05-29 |