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Completed

NCT Number: NCT00724113

ARTHRO Distension Plus Intensive Mobilisation in Shoulder Capsulitis

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

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Key information

Conditions

Shoulder Capsulitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Rheumatology department of Lariboisiere hospital

Paris, 75010, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

infiltration intra articular

Procedure

infiltration intra articular at inclusion with XYLOCAINE 1%

Other names: infiltration intra articular at inclusion with XYLOCAINE 1%

ARTHRO distension plus intensive mobilisation

Procedure

ARTHRO distension plus intensive mobilisation

Primary outcomes

  1. Pain and disability using SPADI score at 2 weeks

    Time frame: at 2 weeks

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: CAPSULITE

Important dates

Study start
2009
Primary completion
2013
Study completion
2014
First posted
Jul 29, 2008
Registry last updated
Jan 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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