ARTHRO Distension Plus Intensive Mobilisation in Shoulder Capsulitis

Evaluation of the Effectiveness of ARTHRO -Distension Plus Intensive Mobilisation in Shoulder Capsulitis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00724113

Acronym

CAPSULITE

Enrollment

Registered

2008-07-29

Start date

2009-02-28

Completion date

2014-07-31

Last updated

2017-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder Capsulitis

Keywords

Shoulder capsulitis, ARTHRO distension, Mobilisation, Randomised clinical trial

Brief summary

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

Detailed 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.

Interventions

PROCEDUREinfiltration intra articular

infiltration intra articular at inclusion with XYLOCAINE 1%

PROCEDUREARTHRO distension plus intensive mobilisation

ARTHRO distension plus intensive mobilisation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Pain and disability using SPADI score at 2 weeks	at 2 weeks

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026