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ARTHRO Distension Plus Intensive Mobilisation in Shoulder Capsulitis (CAPSULITE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00724113
First received: April 9, 2008
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention Phase
Shoulder Capsulitis
Procedure: infiltration intra articular
Procedure: ARTHRO distension plus intensive mobilisation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Effectiveness of ARTHRO -Distension Plus Intensive Mobilisation in Shoulder Capsulitis

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Pain and disability using SPADI score at 2 weeks [ Time Frame: at 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 66
Study Start Date: February 2009
Estimated Study Completion Date: July 2014
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
infiltration intra articular
Procedure: infiltration intra articular
infiltration intra articular at inclusion with XYLOCAINE 1%
Other Name: infiltration intra articular at inclusion with XYLOCAINE 1%
Experimental: 2
ARTHRO distension plus intensive mobilisation
Procedure: ARTHRO distension plus intensive mobilisation
ARTHRO distension plus intensive mobilisation
Other Name: ARTHRO distension plus intensive mobilisation

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00724113

Locations
France
Rheumatology department of Lariboisiere hospital
Paris, France, 75010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Johann Beaudreuil, PH MD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00724113     History of Changes
Other Study ID Numbers: P051039
Study First Received: April 9, 2008
Last Updated: May 19, 2014
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Shoulder capsulitis
ARTHRO distension
Mobilisation
Randomised clinical trial

Additional relevant MeSH terms:
Dilatation, Pathologic
Periarthritis
Arthritis
Bursitis
Joint Diseases
Musculoskeletal Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on November 25, 2014