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Dynamic Humeral Centering in Impingement Syndrome (ADHCIS)

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ClinicalTrials.gov Identifier: NCT01022775
Recruitment Status : Completed
First Posted : December 1, 2009
Last Update Posted : December 1, 2009
Sponsor:
Collaborator:
Information provided by:

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

Condition or disease Intervention/treatment Phase
Degenerative Rotator Cuff Disease With Impingement Syndrome Procedure: Dynamic humeral centering Procedure: Nonspecific mobilisation Phase 3

Detailed Description:
Clinical trial with randomization for treatment and physiotherapist

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment of Dynamic Humeral Centering in Impingement Syndrome: a Randomized Clinical Trial
Study Start Date : April 2001
Primary Completion Date : February 2007
Study Completion Date : February 2007
Arms and Interventions

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.


Outcome Measures

Primary Outcome Measures :
  1. Constant total score as a mean and by category [ Time Frame: at 3 months ]

Secondary Outcome Measures :
  1. Constant total score [ Time Frame: at 12 months ]
  2. 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 ]
  3. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   31 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01022775


Locations
France
Department of Rheumatology, Lariboisière Hospital
Paris, France, 75010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Société Française de Rhumatologie
Investigators
Principal Investigator: Johann BEAUDREUIL, MD,PhD Assistance Publique - Hôpitaux de Paris
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thérèse NGOUE, Department of clinical research and development
ClinicalTrials.gov Identifier: NCT01022775     History of Changes
Other Study ID Numbers: P000203
CRC99241 ( Other Identifier: Department of clinical research and development )
First Posted: December 1, 2009    Key Record Dates
Last Update Posted: December 1, 2009
Last Verified: November 2009

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Degenerative rotator cuff disease
Impingement syndrome
Dynamic humeral centering
Randomized clinical trial

Additional relevant MeSH terms:
Syndrome
Rotator Cuff Injuries
Disease
Pathologic Processes
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries