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

NCT04653636 | Completed

• 1 other identifier: APHP190073
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Adhesive Capsulitis

Outcome Measures

Primary Outcomes (1)

• Physical Impairment: numeric verbal scale of pain

  self-evaluated numeric verbal scale of pain, ranging from 0 to 10 (lesser is better)

  1 month

Secondary Outcomes (8)

• Physical Impairment: numeric verbal scale of night pain

  1 month

• Physical Impairment: numeric verbal scale of maximum pain

  1 month

• Disability : numeric verbal scale of disability

  1 month

• Physical Impairment : mobility of shoulder joints

  1 month

• Psychological Impairment : Hospital Anxiety and Depression Scale (HADS)

  1 month

Study Arms (1)

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.

Other: Arthrographic distension; Other: Immediate joint mobilization

Interventions

Arthrographic distension 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

Also known as: Shoulder joint capsule arthrographic distension

Adhesive capsulitis

Immediate joint mobilization 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.

Also known as: Intensive mobilization

Adhesive capsulitis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

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

Paris, IDF, 75014, France

Location

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Marie-Martine LEFEVRE-COLAU, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: December 4, 2020
• Study Start: October 9, 2020
• Primary Completion: October 21, 2022
• Study Completion: November 14, 2022
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)