The Global Shoulder Concept (GSC) Method Versus Classic Physical Therapy for Shoulder Tendinitis - Full Text View

Purpose

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.

Condition	Intervention
Shoulder Tendinopathy	Procedure: GSC physical therapy Procedure: Standard physical therapy


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Comparison of the Global Shoulder Concept (GSC) Method Versus Classic Physical Therapy for Shoulder Tendinitis: a Prospective, Randomized Study

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MedlinePlus related topics: Health Checkup

U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:

change in FI2S score [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in visual analog scale for pain [ Time Frame: Day 1 versus baseline ] [ Designated as safety issue: Yes ]
Change in visual analog scale for pain [ Time Frame: Day 5 versus baseline ] [ Designated as safety issue: Yes ]
Change in visual analog scale for pain [ Time Frame: Day 12 versus baseline ] [ Designated as safety issue: Yes ]
Change in visual analog scale for pain [ Time Frame: Day 19 versus baseline ] [ Designated as safety issue: Yes ]
Change in visual analog scale for pain [ Time Frame: Day 26 versus baseline ] [ Designated as safety issue: Yes ]
Change in visual analog scale for pain [ Time Frame: Day 90 versus baseline ] [ Designated as safety issue: Yes ]
Scapulohumeral amplitude gain in 3 main directions [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
Passive and active mobility are evaluated by manual goniometry.
Scapulohumeral amplitude gain in 3 main directions [ Time Frame: Day 26 ] [ Designated as safety issue: No ]
Passive and active mobility are evaluated by manual goniometry.
Scapulohumeral amplitude gain in 3 main directions [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
Passive and active mobility are evaluated by manual goniometry.
Functional gain as measured by the DASH self questionnaire [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
Functional gain as measured by the DASH self questionnaire [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
Functional gain as measured by the DASH self questionnaire [ Time Frame: Day 12 ] [ Designated as safety issue: No ]
Functional gain as measured by the DASH self questionnaire [ Time Frame: Day 19 ] [ Designated as safety issue: No ]
Functional gain as measured by the DASH self questionnaire [ Time Frame: Day 26 ] [ Designated as safety issue: No ]
Functional gain as measured by the DASH self questionnaire [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
FI2S score [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
FI2S score [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
FI2S score [ Time Frame: Day 12 ] [ Designated as safety issue: No ]
FI2S score [ Time Frame: Day 19 ] [ Designated as safety issue: No ]
FI2S score [ Time Frame: Day 26 ] [ Designated as safety issue: No ]
SF36 self questionnaire [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
SF36 self questionnaire [ Time Frame: Day 26 ] [ Designated as safety issue: No ]
SF36 self questionnaire [ Time Frame: Day 90 ] [ Designated as safety issue: No ]


Estimated Enrollment:	80
Study Start Date:	October 2012
Estimated Study Completion Date:	January 2016
Estimated Primary Completion Date:	January 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: GSC physcial therapy Patients included in this arm of the study will follow the Global Shoulder Concept physical therapy sequence.	Procedure: GSC physical therapy Global Shoulder Concept physical therapy sequence for shoulder tendonitis. The procedures used in this protocol refer to physical therapy sequences, not to devices or drugs.
Active Comparator: Standard Patients in this arm of the study will follow the standard physical therapy sequence.	Procedure: Standard physical therapy Standard physical therapy sequence for shoulder tendonitis. The procedures used in this protocol refer to physical therapy sequences, not to devices or drugs.

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.

Eligibility


Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01544244

Contacts


Contact: Dominique Richard	+33.(0)4.66.68.34.60	dominique.richard@chu-nimes.fr
Contact: Carey M Suehs, PhD	+33.(0)4.66.68.67.88	carey.suehs@chu-nimes.fr

Locations


France
CHU de Montpellier - Hôpital Lapeyronie	Recruiting
Montpellier, France, 34295
Sub-Investigator: Isabelle Tavares, MD
Sub-Investigator: Catherine Bataille
Sub-Investigator: Marc Julia, MD
Sub-Investigator: Céline Grosjean, MD
Sub-Investigator: Isabelle Laffont, MD, PhD
Sub-Investigator: Yaelle Van Raay, MD
Sub-Investigator: Matthieu Vaucher, MD
CHU de Nîmes - Hôpital Universitaire Carémeau	Recruiting
Nîmes Cedex 9, France, 30029
Principal Investigator: Arnaud Dupeyron, MD PhD
Sub-Investigator: Dominique Richard

Sponsors and Collaborators

Centre Hospitalier Universitaire de Nīmes

Investigators


Study Director:	Dominique Richard	Centre Hospitalier Universitaire de Nîmes
Principal Investigator:	Arnaud Dupeyron, MD PhD	Centre Hospitalier Universitaire de Nîmes

More Information

No publications provided


Responsible Party:	Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:	NCT01544244 History of Changes
Other Study ID Numbers:	PHRIP/2011/DR-03, 2011-A01168-33
Study First Received:	February 23, 2012
Last Updated:	November 3, 2014
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) France: Committee for the Protection of Personnes

Keywords provided by Centre Hospitalier Universitaire de Nīmes:


comparison of physical therapy strategies

ClinicalTrials.gov processed this record on March 03, 2015