ARTHRO Distension Plus Intensive Mobilisation in Shoulder Capsulitis

Assistance Publique - Hôpitaux de Paris66 enrolled

Overview

The purpose of this study is to evaluate the effectiveness of ARTHRO distension plus intensive mobilisation in shoulder capsulitis.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Shoulder Capsulitis

Interventions

infiltration intra articularPROCEDURE

infiltration intra articular at inclusion with XYLOCAINE 1%

ARTHRO distension plus intensive mobilisationPROCEDURE

ARTHRO distension plus intensive mobilisation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Rheumatology department of Lariboisiere hospital

Paris, France

Outcomes

Primary Outcomes

Pain and disability using SPADI score at 2 weeks

Time frame: at 2 weeks

Data from ClinicalTrials.gov

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