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ARTHRO Distension Plus Intensive Mobilisation in Shoulder Capsulitis (CAPSULITE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00724113
First Posted: July 29, 2008
Last Update Posted: January 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  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
Intervention Model: Parallel Assignment
Masking: Single (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 ]

Enrollment: 66
Study Start Date: February 2009
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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00724113     History of Changes
Other Study ID Numbers: P051039
First Submitted: April 9, 2008
First Posted: July 29, 2008
Last Update Posted: January 4, 2017
Last Verified: May 2014

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

Additional relevant MeSH terms:
Bursitis
Dilatation, Pathologic
Periarthritis
Joint Diseases
Musculoskeletal Diseases
Pathological Conditions, Anatomical
Arthritis
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action