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ARTHRO Distension Plus Intensive Mobilisation in Shoulder Capsulitis (CAPSULITE)

Primary Purpose

Shoulder Capsulitis

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
infiltration intra articular
ARTHRO distension plus intensive mobilisation
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Capsulitis focused on measuring Shoulder capsulitis, ARTHRO distension, Mobilisation, Randomised clinical trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Rheumatology department of Lariboisiere hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

infiltration intra articular

ARTHRO distension plus intensive mobilisation

Outcomes

Primary Outcome Measures

Pain and disability using SPADI score at 2 weeks

Secondary Outcome Measures

Full Information

First Posted
April 9, 2008
Last Updated
January 3, 2017
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT00724113
Brief Title
ARTHRO Distension Plus Intensive Mobilisation in Shoulder Capsulitis
Acronym
CAPSULITE
Official Title
Evaluation of the Effectiveness of ARTHRO -Distension Plus Intensive Mobilisation in Shoulder Capsulitis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Capsulitis
Keywords
Shoulder capsulitis, ARTHRO distension, Mobilisation, Randomised clinical trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
infiltration intra articular
Arm Title
2
Arm Type
Experimental
Arm Description
ARTHRO distension plus intensive mobilisation
Intervention Type
Procedure
Intervention Name(s)
infiltration intra articular
Other Intervention Name(s)
infiltration intra articular at inclusion with XYLOCAINE 1%
Intervention Description
infiltration intra articular at inclusion with XYLOCAINE 1%
Intervention Type
Procedure
Intervention Name(s)
ARTHRO distension plus intensive mobilisation
Intervention Description
ARTHRO distension plus intensive mobilisation
Primary Outcome Measure Information:
Title
Pain and disability using SPADI score at 2 weeks
Time Frame
at 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johann Beaudreuil, PH MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rheumatology department of Lariboisiere hospital
City
Paris
ZIP/Postal Code
75010
Country
France

12. IPD Sharing Statement

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ARTHRO Distension Plus Intensive Mobilisation in Shoulder Capsulitis

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