A Pilot Superiority Study Comparing the Efficacy of a Com... | NCT07680504

ID	Type	Description	Link
2026-525317-31-00	EU Trial (CTIS) Number

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 25, 2026Estimated

Primary Completion Date

Jun 25, 2029Estimated

Completion Date

Jun 25, 2029Estimated

First Submitted Date

Jun 18, 2026

First Submission Date that Met QC Criteria

Jun 25, 2026

First Posted Date

Jul 2, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 25, 2026

Last Update Posted Date

Jul 2, 2026Actual

Description Module

Brief 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 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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

38Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	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.	Drug: Saline (0.9% NaCl)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Diprostene	Drug	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Difference in Quick DASH scores between baseline and M3		3 months

Secondary Outcomes

Measure	Description	Time Frame
1. Functional Assessment	Function using the Quick Dash	D0, Month 1, Month 3, Month 6, month 12
1. Functional Assessment	Function using the SPADI scores

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- 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)*
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D002712	Chlorides
D006851	Hydrochloric Acid
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017670	Sodium Compounds