Physiotherapy and Capsulitis | NCT01789463

Studies
Physiotherapy and Capsulitis

NCT01789463

Sponsor

Hopital Foch

Status

Terminated

Last Update Posted

Apr 20, 2016Estimated

Enrollment

10Actual

Phase

Not Applicable

Conditions

Arthritis

Interventions

Self rehabilitation
Self rehabilitation plus physiotherapy

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

recruitment difficulties

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

Apr 2013Actual

Completion Date

Jun 2013Actual

First Submitted Date

Jan 10, 2013

First Submission Date that Met QC Criteria

Feb 11, 2013

First Posted Date

Feb 12, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 19, 2016

Last Update Posted Date

Apr 20, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Self rehabilitation	Active Comparator	Self rehabilitation	Other: Self rehabilitation
Self rehabilitation plus physiotherapy	Experimental	Self rehabilitation plus physiotherapy	Other: Self rehabilitation plus physiotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Self rehabilitation	Other		Self rehabilitation
Self rehabilitation plus physiotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Function of the shoulder joint (Score de Constant)		12 months post shoulder dilatation

Secondary Outcomes

Measure	Description	Time Frame
Pain Visual Analogue Scale (at evening, rest, and at movement)		12 months post shoulder dilatation

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bernard BOISAUBERT, MD	Hôpital FOCH 40, rue Worth 92150 Suresnes	Study Chair
Louis FRANCESCHI, MD	IMM - 42, boulevard Jourdan 75014 Paris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital FOCH		Suresnes		92150	France

Condition Browse Module

MeSH Terms

ID	Term
D001168	Arthritis

Ancestor Terms

ID	Term
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D026741	Physical Therapy Modalities

Ancestor Terms

ID	Term
D013812	Therapeutics
D012046	Rehabilitation

Browse Leaves

Not provided

Browse Branches

Not provided