ARTHRO Distension Plus Intensive Mobilisation in Shoulder Capsulitis
This trial has been completed.
|Treatments||infiltration intra articular, arthro distension plus intensive mobilisation|
|Sponsor||Assistance Publique - Hôpitaux de Paris|
|Start date||February 2009|
|End date||August 2013|
|Trial size||66 participants|
|Trial identifier||NCT00724113, P051039|
The purpose of this study is to evaluate the effectiveness of ARTHRO distension plus intensive mobilisation in shoulder capsulitis.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (investigator)|
Pain and disability using SPADI score at 2 weeks
time frame: at 2 weeks
Male or female participants at least 18 years old.
Inclusion Criteria: - age ≥ 18 years - shoulder capsulitis - duration of symptoms ≥ 3 months - health insurance Exclusion Criteria: - cognitive disorders - Hypo coagulation - biological inflammatory syndrome - uncontrolled diabetes - XYLOCAINE allergy - pregnancy - unable to understand and to speak french - previous surgery of shoulder - shoulder infiltration or distension in the previous month - local contraindication to shoulder infiltration
|Official title||Evaluation of the Effectiveness of ARTHRO -Distension Plus Intensive Mobilisation in Shoulder Capsulitis|
|Principal investigator||Johann Beaudreuil, PH MD|
|Description||The aim of the study is to evaluate a treatment of shoulder capsulitis that associates ARTHRO distension and intensive mobilisation at 2, 6, 12, 26 and 52 weeks. It is a bicentric 87-month (inclusion: 74 months; follow up: 13 months) observer blind randomised clinical trial using 2 groups in parallel. The number of patients to be included is 66. The treatment that is evaluated associates ARTHRO distension followed by mobilisation of the shoulder 6 hours per day during 5 days, and then sessions of physiotherapy for 4 weeks. The control intervention is one intra-articular injection of corticosteroids and physiotherapy. The primary outcome is SPADI, namely pain and disability, at 2 weeks.|
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