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 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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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 ]

Secondary Outcome Measures:

Change in visual analog scale for pain [ Time Frame: Day 1 versus baseline ]
Change in visual analog scale for pain [ Time Frame: Day 5 versus baseline ]
Change in visual analog scale for pain [ Time Frame: Day 12 versus baseline ]
Change in visual analog scale for pain [ Time Frame: Day 19 versus baseline ]
Change in visual analog scale for pain [ Time Frame: Day 26 versus baseline ]
Change in visual analog scale for pain [ Time Frame: Day 90 versus baseline ]
Scapulohumeral amplitude gain in 3 main directions [ Time Frame: Day 1 ]
Passive and active mobility are evaluated by manual goniometry.
Scapulohumeral amplitude gain in 3 main directions [ Time Frame: Day 26 ]
Passive and active mobility are evaluated by manual goniometry.
Scapulohumeral amplitude gain in 3 main directions [ Time Frame: Day 90 ]
Passive and active mobility are evaluated by manual goniometry.
Functional gain as measured by the DASH self questionnaire [ Time Frame: Day 1 ]
Functional gain as measured by the DASH self questionnaire [ Time Frame: Day 5 ]
Functional gain as measured by the DASH self questionnaire [ Time Frame: Day 12 ]
Functional gain as measured by the DASH self questionnaire [ Time Frame: Day 19 ]
Functional gain as measured by the DASH self questionnaire [ Time Frame: Day 26 ]
Functional gain as measured by the DASH self questionnaire [ Time Frame: Day 90 ]
FI2S score [ Time Frame: Day 1 ]
FI2S score [ Time Frame: Day 5 ]
FI2S score [ Time Frame: Day 12 ]
FI2S score [ Time Frame: Day 19 ]
FI2S score [ Time Frame: Day 26 ]
SF36 self questionnaire [ Time Frame: Day 1 ]
SF36 self questionnaire [ Time Frame: Day 26 ]
SF36 self questionnaire [ Time Frame: Day 90 ]


Enrollment:	40
Study Start Date:	October 2012
Study Completion Date:	May 2016
Primary Completion Date:	May 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 (Adult, Senior)
Sexes Eligible for Study:	All
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

Locations


France
CHU de Montpellier - Hôpital Lapeyronie
Montpellier, France, 34295
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes Cedex 9, France, 30029

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


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 ( Other Identifier: RCB number )
Study First Received:	February 23, 2012
Last Updated:	June 2, 2016

Keywords provided by Centre Hospitalier Universitaire de Nīmes:


comparison of physical therapy strategies

Additional relevant MeSH terms:


Tendinopathy Muscular Diseases Musculoskeletal Diseases Tendon Injuries Wounds and Injuries

ClinicalTrials.gov processed this record on June 22, 2017