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Dynamic Humeral Centering in Impingement Syndrome (ADHCIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01022775
Recruitment Status : Completed
First Posted : December 1, 2009
Last Update Posted : December 1, 2009
Sponsor:
Collaborator:
Societe Francaise de Rhumatologie
Information provided by:
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE November 30, 2009
First Posted Date  ICMJE December 1, 2009
Last Update Posted Date December 1, 2009
Study Start Date  ICMJE April 2001
Actual Primary Completion Date February 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2009)
Constant total score as a mean and by category [ Time Frame: at 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2009)
  • Constant total score [ Time Frame: 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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 Arms  ICMJE
  • 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 *

*   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
Actual Enrollment  ICMJE
 (submitted: November 30, 2009)
70
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2007
Actual 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 31 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01022775
Other Study ID Numbers  ICMJE P000203
CRC99241 ( Other Identifier: Department of clinical research and development )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Thérèse NGOUE, Department of clinical research and development
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Societe Francaise de Rhumatologie
Investigators  ICMJE
Principal Investigator: Johann BEAUDREUIL, MD,PhD Assistance Publique - Hôpitaux de Paris
PRS Account 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