Dynamic Humeral Centering in Impingement Syndrome

Degenerative Rotator Cuff Disease With Impingement Syndrome Clinical Trial

— ADHCIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01022775
• Other study ID #: P000203
• Secondary ID: CRC99241
• Status: Completed
• Phase: Phase 3
• First received: November 30, 2009
• Last updated: November 30, 2009
• Start date: April 2001
• Est. completion date: February 2007

Study information

• Verified date: November 2009
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Description:

Clinical trial with randomization for treatment and physiotherapist

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 31 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Degenerative Rotator Cuff Disease With Impingement Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
France	Department of Rheumatology, Lariboisière Hospital	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Société Française de Rhumatologie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Constant total score as a mean and by category		at 3 months	No
Secondary	Constant total score		at 12 months	No
Secondary	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	No
Secondary	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	No