NCT00724113

Brief Summary

The purpose of this study is to evaluate the effectiveness of ARTHRO distension plus intensive mobilisation in shoulder capsulitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2009

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2008

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 29, 2008

Completed
6 months until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

January 4, 2017

Status Verified

May 1, 2014

Enrollment Period

4.5 years

First QC Date

April 9, 2008

Last Update Submit

January 3, 2017

Conditions

Shoulder Capsulitis

Keywords

Shoulder capsulitisARTHRO distensionMobilisationRandomised clinical trial

Outcome Measures

Primary Outcomes (1)

  • Pain and disability using SPADI score at 2 weeks

    at 2 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

infiltration intra articular

Procedure: infiltration intra articular

2

EXPERIMENTAL

ARTHRO distension plus intensive mobilisation

Procedure: ARTHRO distension plus intensive mobilisation

Interventions

infiltration intra articularPROCEDURE

infiltration intra articular at inclusion with XYLOCAINE 1%

Also known as: infiltration intra articular at inclusion with XYLOCAINE 1%
1
ARTHRO distension plus intensive mobilisationPROCEDURE

ARTHRO distension plus intensive mobilisation

2

Eligibility Criteria

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

You may qualify if:

  • age ≥ 18 years
  • shoulder capsulitis
  • duration of symptoms ≥ 3 months
  • health insurance

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rheumatology department of Lariboisiere hospital

Paris, 75010, France

Location

Related Publications (1)

  • Jacob L, Lasbleiz S, Sanchez K, Morchoisne O, Lefevre-Colau MM, Nguyen C, Rannou F, Feydy A, Portal JJ, Schnitzler A, Vicaut E, Laredo JD, Richette P, Orcel P, Beaudreuil J. Arthro-distension with early and intensive mobilization for shoulder adhesive capsulitis: A randomized controlled trial. Ann Phys Rehabil Med. 2024 Sep;67(6):101852. doi: 10.1016/j.rehab.2024.101852. Epub 2024 Jun 1.

    PMID: 38824872DERIVED

Study Officials

  • Johann Beaudreuil, PH MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2008

First Posted

July 29, 2008

Study Start

February 1, 2009

Primary Completion

August 1, 2013

Study Completion

July 1, 2014

Last Updated

January 4, 2017

Record last verified: 2014-05

Locations

FR(1)