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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Shoulder; Tendinopathy	Procedure: GSC physical therapy; Procedure: Standard physical therapy	Not Applicable

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 Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	40 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (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
Study Start Date :	October 2012
Actual Primary Completion Date :	May 2016
Actual Study Completion Date :	May 2016

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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.

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. change in FI2S score [ Time Frame: 90 days ]

Secondary Outcome Measures :

1. Change in visual analog scale for pain [ Time Frame: Day 1 versus baseline ]
2. Change in visual analog scale for pain [ Time Frame: Day 5 versus baseline ]
3. Change in visual analog scale for pain [ Time Frame: Day 12 versus baseline ]
4. Change in visual analog scale for pain [ Time Frame: Day 19 versus baseline ]
5. Change in visual analog scale for pain [ Time Frame: Day 26 versus baseline ]
6. Change in visual analog scale for pain [ Time Frame: Day 90 versus baseline ]
7. Scapulohumeral amplitude gain in 3 main directions [ Time Frame: Day 1 ]
   Passive and active mobility are evaluated by manual goniometry.
8. Scapulohumeral amplitude gain in 3 main directions [ Time Frame: Day 26 ]
   Passive and active mobility are evaluated by manual goniometry.
9. Scapulohumeral amplitude gain in 3 main directions [ Time Frame: Day 90 ]
   Passive and active mobility are evaluated by manual goniometry.
10. Functional gain as measured by the DASH self questionnaire [ Time Frame: Day 1 ]
11. Functional gain as measured by the DASH self questionnaire [ Time Frame: Day 5 ]
12. Functional gain as measured by the DASH self questionnaire [ Time Frame: Day 12 ]
13. Functional gain as measured by the DASH self questionnaire [ Time Frame: Day 19 ]
14. Functional gain as measured by the DASH self questionnaire [ Time Frame: Day 26 ]
15. Functional gain as measured by the DASH self questionnaire [ Time Frame: Day 90 ]
16. FI2S score [ Time Frame: Day 1 ]
17. FI2S score [ Time Frame: Day 5 ]
18. FI2S score [ Time Frame: Day 12 ]
19. FI2S score [ Time Frame: Day 19 ]
20. FI2S score [ Time Frame: Day 26 ]
21. SF36 self questionnaire [ Time Frame: Day 1 ]
22. SF36 self questionnaire [ Time Frame: Day 26 ]
23. SF36 self questionnaire [ Time Frame: Day 90 ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 )
First Posted:	March 5, 2012
Last Update Posted:	June 3, 2016
Last Verified:	June 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