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
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment of Dynamic Humeral Centering in Impingement Syndrome: a Randomized Clinical Trial

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 70
Study Start Date: April 2001
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:

Clinical trial with randomization for treatment and physiotherapist

  Eligibility

Ages Eligible for Study:   31 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Assistance Publique - Hôpitaux de Paris

Additional 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
Study First Received: November 30, 2009
Last Updated: November 30, 2009
Health Authority: France: Ministry of Health

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

ClinicalTrials.gov processed this record on April 15, 2014