Clinical trial NCT04653636: MRI and Clinical Predictive Factors of the Response to Arthrographic Distension in Severe Capsulitis
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Adhesive Capsulitis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-12-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Physical Impairment: numeric verbal scale of pain
timeFrame: 1 month
Secondary outcomes:
measure: Physical Impairment: numeric verbal scale of night pain
timeFrame: 1 month
measure: Physical Impairment: numeric verbal scale of maximum pain
timeFrame: 1 month
measure: Disability : numeric verbal scale of disability
timeFrame: 1 month
measure: Physical Impairment : mobility of shoulder joints
timeFrame: 1 month
measure: Psychological Impairment : Hospital Anxiety and Depression Scale (HADS)
timeFrame: 1 month
measure: Fear-Avoidance Beliefs Questionnaire (FABQ)
timeFrame: 1 month
measure: Shoulder Pain and Disability Index (SPADI)
timeFrame: 1 month
measure: Disabilities of the Arm, Shoulder and Hand (DASH)
timeFrame: 1 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis
state: IDF
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Marie-Martine LEFEVRE-COLAU, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: