Clinical Trials Directory

Trials / Completed

CompletedNCT04653636

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

Clinical and MRI Predictive Factors of the Response to Arthrographic Distension and Intensive Physiotherapy in Severe Capsulitis: Improvement of Pain and Function at 1 Month

Status
Completed
Phase
Study type
Observational
Enrollment
55 (actual)
Sponsor
Assistance Publique - Hôpitaux de Paris · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
OTHERArthrographic distensionThe 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
OTHERImmediate joint mobilizationThis 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.

Timeline

Start date
2020-10-09
Primary completion
2022-10-21
Completion
2022-11-14
First posted
2020-12-04
Last updated
2025-09-12

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04653636. Inclusion in this directory is not an endorsement.