The Global Shoulder Concept (GSC) Method Versus Classic Physical Therapy for Shoulder Tendinitis

Not Applicable

Terminated

• Conditions: Shoulder; Tendinopathy
• Interventions: Procedure: Standard physical therapy; Procedure: GSC physical therapy

• Registration Number: NCT01544244
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

The primary objective of this study is to demonstrate the superiority of the CGE physical therapy protocol versus a standard physical therapy protocol of the shoulder by measuring the following after 1 month of physical therapy: the FI2S score including validated measures of pain, glenohumeral joint range of motion in the three planes, the ability to perform certain everyday activities and the strength of forward elevation measured with a dynamometer.

Detailed Description

Secondary objectives:

* To study the evolution of passive glenohumeral range of motion

* To study the evolution of the global range of passive and active motion for each method used

* To evaluate functional recovery (DASH)

* To evaluate the impact on quality of life (SF36)

* To study the difference in visual analog scale scores for pain during physical therapy sessions

* Compare the two methods/groups after three months.

Study Timeline

• Study First Submitted: 2012-02-23
• Study First Submitted QC: 2012-03-02
• Study First Posted: 2012-03-05
• Study Start: 2012-10
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-02
• Last Update Posted: 2016-06-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• The patient must have given his/her informed and signed consent
• The patient must be insured or beneficiary of a health insurance plan
• painful, chronic tendinopathy (more than 3 months) of the rotator cuff, confirmed by MRI

Exclusion Criteria

• The patient is pregnant or breastfeeding
• Any emergency situation
• Non-mechanical tendinopathies (metabolic, neurological, capsulitis, reflex sympathetic dystrophy) and tendon surgery (tendon surgery and acromioplasty)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard	Standard physical therapy	Patients in this arm of the study will follow the standard physical therapy sequence.
GSC physcial therapy	GSC physical therapy	Patients included in this arm of the study will follow the Global Shoulder Concept physical therapy sequence.

Primary Outcome Measures

Name	Time	Method
change in FI2S score	90 days

Secondary Outcome Measures

Name	Time	Method
Change in visual analog scale for pain	Day 90 versus baseline
Scapulohumeral amplitude gain in 3 main directions	Day 90	Passive and active mobility are evaluated by manual goniometry.
Functional gain as measured by the DASH self questionnaire	Day 90
FI2S score	Day 26
SF36 self questionnaire	Day 90

Trial Locations

Locations (2)

CHU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 9, France

CHU de Montpellier - Hôpital Lapeyronie; 🇫🇷 Montpellier, France