Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis
Paris, IDF, 75014, France
NCT Number: NCT04653636
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.
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Notify Me18 year and older
All sexes
Observational
Paris, IDF, 75014, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Shoulder joint capsule arthrographic distension
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.
Other names: Intensive mobilization
Time frame: 1 month
self-evaluated numeric verbal scale of pain, ranging from 0 to 10 (lesser is better)
Time frame: 1 month
self-evaluated numeric verbal scale of night pain ranging from 0 to 10 (lesser is better)
Time frame: 1 month
self-evaluated numeric verbal scale of maximum pain ranging from 0 to 10 (lesser is better)
Time frame: 1 month
self-evaluated numeric verbal scale of disability ranging from 0 to 10 (lesser is better)
Time frame: 1 month
mobility and rotation
Time frame: 1 month
Questionnaire possible presence of anxiety and depressive states It contains two 7-item scales: one for anxiety and one for depression both with a score range of 0-21.
Time frame: 1 month
Patient reported questionnaire which specifically focuses on how a patient's fear avoidance beliefs about physical activity and work.
The questionnaire consists of 16 items in which a patient rates their agreement with each statement on a 7-point Likert scale. Where 0= completely disagree, 6=completely agree. There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs There are two subscales; the work subscale (FABQw) with 7 questions (maximum score of 42) and the physical activity subscale (FABQpa) with 4 questions (maximum score of 24).
Time frame: 1 month
self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. Total score ranging from 0 (best) to 100 (worst).
Time frame: 1 months
Self-administered questionnaire assessing quality of life of the upper limb. It assesses the ability to perform 23 activities, the severity of symptoms 30-item self-reported questionnaire in which the response options are presented as 5-point Likert scales.
Scores range from 0 (no disability) to 100 (most severe disability). In addition there are two optional modules of four questions each, sporting or instrumental and employment activity.
Assistance Publique - Hôpitaux de Paris
Other
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
Acronym: IRCAP
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