NCT01022775

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2001

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2001

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 1, 2009

Completed
Last Updated

December 1, 2009

Status Verified

November 1, 2009

Enrollment Period

5.8 years

First QC Date

November 30, 2009

Last Update Submit

November 30, 2009

Conditions

Degenerative Rotator Cuff Disease With Impingement Syndrome

Keywords

Degenerative rotator cuff diseaseImpingement syndromeDynamic humeral centeringRandomized clinical trial

Outcome Measures

Primary Outcomes (1)

  • Constant total score as a mean and by category

    at 3 months

Secondary Outcomes (3)

  • Constant total score

    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

    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

    at 12 months

Study Arms (2)

1: Dynamic humeral centering

EXPERIMENTAL

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

Procedure: Dynamic humeral centering

2: Nonspecific mobilisation

ACTIVE COMPARATOR

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

Procedure: Nonspecific mobilisation

Interventions

Dynamic humeral centeringPROCEDURE

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

1: Dynamic humeral centering
Nonspecific mobilisationPROCEDURE

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

2: Nonspecific mobilisation

Eligibility Criteria

Age31 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Rheumatology, Lariboisière Hospital

Paris, 75010, France

Location

Related Publications (2)

  • Beaudreuil J, Ostertag A, Lasbleiz S, Vicaut E, Yelnik A, Bardin T, Orcel P. Efficacy of dynamic humeral centering according to Neer test results: a stratified analysis of a randomized-controlled trial. Int J Rehabil Res. 2015 Mar;38(1):81-3. doi: 10.1097/MRR.0000000000000079.

    PMID: 25185788DERIVED

  • Beaudreuil J, Lasbleiz S, Richette P, Seguin G, Rastel C, Aout M, Vicaut E, Cohen-Solal M, Liote 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. doi: 10.1136/ard.2010.147694. Epub 2011 May 29.

    PMID: 21623001DERIVED

Study Officials

  • Johann BEAUDREUIL, MD,PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 30, 2009

First Posted

December 1, 2009

Study Start

April 1, 2001

Primary Completion

February 1, 2007

Study Completion

February 1, 2007

Last Updated

December 1, 2009

Record last verified: 2009-11

Locations

FR(1)