Dynamic Humeral Centering in Impingement Syndrome (ADHCIS)

This study has been completed.

Sponsor:

Collaborator:

Société Française de Rhumatologie

Information provided by:

Assistance Publique - Hôpitaux de Paris

ClinicalTrials.gov Identifier:

NCT01022775

First received: November 30, 2009

Last updated: NA

Last verified: November 2009

History: No changes posted

Tracking Information

First Received Date ^ICMJE

November 30, 2009

Last Updated Date

November 30, 2009

Start Date ^ICMJE

April 2001

Primary Completion Date

February 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Constant total score as a mean and by category [ Time Frame: at 3 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Constant total score [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
Constant subscores for pain, activity, mobility and strength, and self-assessed disability on a 0- to 100-point visual analog scale, and analgesic and nonsteroidal anti-inflammatory drug (NSAID) use [ Time Frame: at 3 months ] [ Designated as safety issue: No ]
Constant subscores for pain, activity, mobility and strength, and self-assessed disability on a 0- to 100-point visual analog scale, and analgesic and nonsteroidal anti-inflammatory drug (NSAID) use [ Time Frame: at 12 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Dynamic Humeral Centering in Impingement Syndrome

Official Title ^ICMJE

Assessment of Dynamic Humeral Centering in Impingement Syndrome: a Randomized Clinical Trial

Brief Summary

The purpose of this study is to determine wether dynamic humeral centering is effective in patients with impingement syndrome of the shoulder

Detailed Description

Clinical trial with randomization for treatment and physiotherapist

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Degenerative Rotator Cuff Disease With Impingement Syndrome

Intervention ^ICMJE

Procedure: Dynamic humeral centering
Dynamic humeral centering performed for 6 weeks, in 15 supervised individual outpatient sessions, plus daily home exercises for 12 months.
Procedure: Nonspecific mobilisation
Nonspecific mobilisation performed for 6 weeks, in 15 supervised individual outpatient sessions, plus daily home exercises for 12 months.

Study Arm (s)

Experimental: 1: Dynamic humeral centering
Dynamic humeral centering performed for 6 weeks, in 15 supervised individual outpatient sessions, plus daily home exercises for 12 months.

Intervention: Procedure: Dynamic humeral centering
Active Comparator: 2: Nonspecific mobilisation
Nonspecific mobilisation performed for 6 weeks, in 15 supervised individual outpatient sessions, plus daily home exercises for 12 months.

Intervention: Procedure: Nonspecific mobilisation

Publications *

Beaudreuil J, Lasbleiz S, Richette P, Seguin G, Rastel C, Aout M, Vicaut E, Cohen-Solal M, Lioté F, de Vernejoul MC, Bardin T, Orcel P. Assessment of dynamic humeral centering in shoulder pain with impingement syndrome: a randomised clinical trial. Ann Rheum Dis. 2011 Sep;70(9):1613-8. Epub 2011 May 29.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2007

Primary Completion Date

February 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

age > 30 years
pain duration > 1 month
presence of at least 2 positive impingement test results from Neer, Yocum and Hawkins testing
total Constant score < 80.

Exclusion Criteria: concerning the shoulder

stiffness
anteroposterior instability
tendinous calcification
corticosteroid injection within the previous 30 days
previous surgery
humeral fracture
inflammatory joint disease
neoplastic disorders

Gender

Both

Ages

31 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01022775

Other Study ID Numbers ^ICMJE

P000203, CRC99241

Has Data Monitoring Committee

Responsible Party

Thérèse NGOUE, Department of clinical research and development

Study Sponsor ^ICMJE

Assistance Publique - Hôpitaux de Paris

Collaborators ^ICMJE

Société Française de Rhumatologie

Investigators ^ICMJE

Principal Investigator:

Johann BEAUDREUIL, MD,PhD

Assistance Publique - Hôpitaux de Paris

Information Provided By

Assistance Publique - Hôpitaux de Paris

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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