ARTHRO Distension Plus Intensive Mobilisation in Shoulder Capsulitis (CAPSULITE)

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 3

Conditions: Shoulder Capsulitis

Treatments: Procedure: infiltration intra articular; Procedure: ARTHRO distension plus intensive mobilisation

Study type: Interventional

Funder types: Other

Identifiers

NCT00724113

P051039

Details and patient eligibility

About

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

Full 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.

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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66 participants in 2 patient groups

1

Active Comparator group

Description:

infiltration intra articular

Treatment:

Procedure: infiltration intra articular

2

Experimental group

Description:

ARTHRO distension plus intensive mobilisation

Treatment:

Procedure: ARTHRO distension plus intensive mobilisation