NCT01789463

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 12, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

April 20, 2016

Status Verified

April 1, 2016

Enrollment Period

3 years

First QC Date

January 10, 2013

Last Update Submit

April 19, 2016

Conditions

Arthritis

Outcome Measures

Primary Outcomes (1)

  • Function of the shoulder joint (Score de Constant)

    12 months post shoulder dilatation

Secondary Outcomes (1)

  • Pain Visual Analogue Scale (at evening, rest, and at movement)

    12 months post shoulder dilatation

Study Arms (2)

Self rehabilitation

ACTIVE COMPARATOR

Self rehabilitation

Other: Self rehabilitation

Self rehabilitation plus physiotherapy

EXPERIMENTAL

Self rehabilitation plus physiotherapy

Other: Self rehabilitation plus physiotherapy

Interventions

Self rehabilitationOTHER
Self rehabilitation
Self rehabilitation plus physiotherapyOTHER
Self rehabilitation plus physiotherapy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary idiopathic phase 2 capsulitis
  • Diagnosis of capsulitis confirmed by shoulder dilatation
  • Patients between 18 and 70 years of age

You may not qualify if:

  • Secondary capsulitis
  • Shoulder pain of other etiology
  • Cognitive disorders
  • Patients less than 18 years, and more than 70 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital FOCH

Suresnes, 92150, France

Location

MeSH Terms

Conditions

Arthritis

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Bernard BOISAUBERT, MD

    Hôpital FOCH 40, rue Worth 92150 Suresnes

    STUDY CHAIR

  • Louis FRANCESCHI, MD

    IMM - 42, boulevard Jourdan 75014 Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2013

First Posted

February 12, 2013

Study Start

April 1, 2010

Primary Completion

April 1, 2013

Study Completion

June 1, 2013

Last Updated

April 20, 2016

Record last verified: 2016-04

Locations

FR(1)