MRI and Clinical Predictive Factors of the Response to Arthrographic Distension in Severe Capsulitis

NCT ID: NCT04653636

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 55 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-09
• Study Completion Date: 2022-11-14

Brief Summary

The purpose of this study is to identify clinical and MRI factors associated to a better response to arthrographic distension in patients with severe capsulitis.

Detailed Description

Patients presenting to the physical medicine and rehabilitation department [tertiary care] of Cochin Hospital for severe adhesive capsulitis for whom first-line medical treatment is not effective. The first-line treatment including analgesic, NSAIDs and / or intra-articular infiltration of a corticosteroid derivative and multi-weekly physiotherapy

These patients are integrated into a usual protocol (routine care) consisting of performing an MRI with intravenous injection of gadolinium to confirm the diagnostic and eliminated others causes of shoulder stiffness. IV gadolinium-enhanced MRI can increase the performance of the signal analysis changes of the Synovium and capsule in the Axillary Recess and Rotator interval as compared with unenhanced measures The treatment consists in one to three arthrographic distensions by physiological serum, xylocaine 1% and injection of an ampoule of corticosteroids (DIPROSTENE) associated with intensive (immediate mobilization, recovery of maximum amplitudes by the physiotherapist and on arthro-motor). The primary objective of arthrographic distension is the expansion and rupture of the glenohumeral capsule in the subscapularis recess. It consists after local anesthesia, in an injection under pressure of air or liquid - opacifier or physiological serum - in the glenohumeral joint associated with an infiltration of cortisone derivatives at the end of the operation. Physical treatment aimed at rapid amplitude gain is started immediately after the arthrographic distension, under the effect of local anesthesia. It is at best continued daily at a rate of 2 to 8 hours per day for one to 2 weeks. Depending on the effect obtained on pain and the daily progression of rehabilitation, arthro-distension may be repeated once or twice during the mobilization period.

Conditions

Adhesive Capsulitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Adhesive capsulitis

Patients presenting to the physical medicine and rehabilitation department \[tertiary care\] of Cochin Hospital with a clinically diagnosis of severe adhesive capsulitis for whom first-line medical treatment is not effective.

Arthrographic distension

Intervention Type: OTHER

The treatment consists in one to three shoulder joint capsule arthrographic distension. It consists after local anesthesia, in an injection under pressure of xylocaine 1% and physiological serum in the glenohumeral joint associated with an ampoule of corticosteroids (Betamethasone or Triamcinolone hexacetonide ) at the end of the operation.

• first arthrographic distension is performed under scopic guidance
• second and/or third arthrographic distension are performed under ultrasound guidance

Immediate joint mobilization

Intervention Type: OTHER

This procedure was associated with intensive (immediate mobilization, recovery of maximum amplitudes by the physiotherapist and on arthro-motor).

Physical treatment aimed at rapid amplitude gain and is started immediately after the arthrographic distension, under the effect of local anesthesia. It is at best continued daily at a rate of 2 to 8 hours per day for one to 2 weeks. Depending on the effect obtained on pain and the daily progression of rehabilitation, arthrographic distension may be repeated once or twice during the mobilization period.

Interventions

Arthrographic distension

The treatment consists in one to three shoulder joint capsule arthrographic distension. It consists after local anesthesia, in an injection under pressure of xylocaine 1% and physiological serum in the glenohumeral joint associated with an ampoule of corticosteroids (Betamethasone or Triamcinolone hexacetonide ) at the end of the operation.

• first arthrographic distension is performed under scopic guidance
• second and/or third arthrographic distension are performed under ultrasound guidance

Intervention Type: OTHER

Immediate joint mobilization

This procedure was associated with intensive (immediate mobilization, recovery of maximum amplitudes by the physiotherapist and on arthro-motor).

Physical treatment aimed at rapid amplitude gain and is started immediately after the arthrographic distension, under the effect of local anesthesia. It is at best continued daily at a rate of 2 to 8 hours per day for one to 2 weeks. Depending on the effect obtained on pain and the daily progression of rehabilitation, arthrographic distension may be repeated once or twice during the mobilization period.

Intervention Type: OTHER

Other Intervention Names

Shoulder joint capsule arthrographic distension; Intensive mobilization

Eligibility Criteria

Inclusion Criteria

• Age greater than or equal to 18 years,
• Symptomatic shoulder (pain or stiffness) for at least 3 months.
• Patient with failure of treatment including at least NSAIDs, analgesics, +/- intra-articular corticosteroid infiltration and physiotherapy.
• Painful shoulder at inclusion (EN > 5)
• Limitation of passive amplitudes of the glenohumeral joint, of at least 25% of 2 of the 3 mobility sectors (lateral arm elevation, anterior elevation and lateral rotation in the RE1 position), compared to the opposite side
• Absence of glenohumeral arthropathy and abarticular calcification on the standard x-ray of both shoulders.
• Affiliation to a social security
• Information and collection of patient consent

Exclusion Criteria

• Obtain patient consent impossible
• Cognitive disorders considered moderate to severe by the investigator
• Unbalanced diabetes mellitus (glycated hemoglobin> 10%)
• Anticoagulant treatment that cannot be interrupted
• Hemostatic disorders (known history, platelet count <120,000, prothrombin level <75%)
• Allergy to xylocaine, Gadolinium, Diprostene
• Biological inflammatory syndrome
• Pregnant woman (beta human chorionic gonadotropin dosage) or breastfeeding
• Language barrier to the integration of a rehabilitation program or the performance of a reliable assessment.
• People under protective measures
• Refusal to participate

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marie-Martine LEFEVRE-COLAU, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis

Paris, IDF, France

Countries

France

Other Identifiers

APHP190073

Identifier Type: -

Identifier Source: org_study_id