Back to resultsPhysiotherapy and Capsulitis
Primary Purpose
Arthritis
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Self rehabilitation
Self rehabilitation plus physiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Arthritis
Eligibility Criteria
Inclusion Criteria:
- Primary idiopathic phase 2 capsulitis
- Diagnosis of capsulitis confirmed by shoulder dilatation
- Patients between 18 and 70 years of age
- Exclusion Criteria:
- Secondary capsulitis
- Shoulder pain of other etiology
- Cognitive disorders
- Patients less than 18 years, and more than 70 years of age
Sites / Locations
- Hôpital FOCH
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Self rehabilitation
Self rehabilitation plus physiotherapy
Arm Description
Self rehabilitation
Self rehabilitation plus physiotherapy
Outcomes
Primary Outcome Measures
Function of the shoulder joint (Score de Constant)
Secondary Outcome Measures
Pain Visual Analogue Scale (at evening, rest, and at movement)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01789463
Brief Title
Physiotherapy and Capsulitis
Official Title
Physiotherapy Versus Self Rehabilitation After Shoulder Dilatation for Primary Idiopathic Capsulitis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Terminated
Why Stopped
recruitment difficulties
Study Start Date
April 2010 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Multicenter randomised study, on parallel groups to compare recovery of functional amplitude following shoulder dilatation with auto rehabilitation in one group and physiotherapy in the other group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Self rehabilitation
Arm Type
Active Comparator
Arm Description
Self rehabilitation
Arm Title
Self rehabilitation plus physiotherapy
Arm Type
Experimental
Arm Description
Self rehabilitation plus physiotherapy
Intervention Type
Other
Intervention Name(s)
Self rehabilitation
Intervention Type
Other
Intervention Name(s)
Self rehabilitation plus physiotherapy
Primary Outcome Measure Information:
Title
Function of the shoulder joint (Score de Constant)
Time Frame
12 months post shoulder dilatation
Secondary Outcome Measure Information:
Title
Pain Visual Analogue Scale (at evening, rest, and at movement)
Time Frame
12 months post shoulder dilatation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Primary idiopathic phase 2 capsulitis
Diagnosis of capsulitis confirmed by shoulder dilatation
Patients between 18 and 70 years of age
Exclusion Criteria:
Secondary capsulitis
Shoulder pain of other etiology
Cognitive disorders
Patients less than 18 years, and more than 70 years of age
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard BOISAUBERT, MD
Organizational Affiliation
Hôpital FOCH 40, rue Worth 92150 Suresnes
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Louis FRANCESCHI, MD
Organizational Affiliation
IMM - 42, boulevard Jourdan 75014 Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital FOCH
City
Suresnes
ZIP/Postal Code
92150
Country
France
12. IPD Sharing Statement
Learn more about this trial
Physiotherapy and Capsulitis
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