Dynamic Humeral Centering in Impingement Syndrome (ADHCIS)

November 30, 2009 updated by: Assistance Publique - Hôpitaux de Paris

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Clinical trial with randomization for treatment and physiotherapist

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75010
        • Department of Rheumatology, Lariboisière Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

31 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Constant total score as a mean and by category
Time Frame: at 3 months
at 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Constant total score
Time Frame: at 12 months
at 12 months
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
at 3 months
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
at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Societe Francaise de Rhumatologie

Investigators

  • Principal Investigator: Johann BEAUDREUIL, MD,PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2001

Primary Completion (Actual)

February 1, 2007

Study Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

November 30, 2009

First Submitted That Met QC Criteria

November 30, 2009

First Posted (Estimate)

December 1, 2009

Study Record Updates

Last Update Posted (Estimate)

December 1, 2009

Last Update Submitted That Met QC Criteria

November 30, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P000203
  • CRC99241 (Other Identifier: Department of clinical research and development)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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