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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of the Global Shoulder Concept (GSC) Method Versus Classic Physical Therapy for Shoulder Tendinitis: a Prospective, Randomized Study

Conditions
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Shoulder, Tendinopathy

Intervention / Treatment
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* Procedure: GSC physical therapy
* Procedure: Standard physical therapy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GSC physcial therapy<br>Patients included in this arm of the study will follow the Global Shoulder Concept physical therapy sequence. | Procedure: GSC physical therapy<br>* 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.<br>|
| Active Comparator: Standard<br>Patients in this arm of the study will follow the standard physical therapy sequence. | Procedure: Standard physical therapy<br>* Standard physical therapy sequence for shoulder tendonitis. The procedures used in this protocol refer to physical therapy sequences, not to devices or drugs.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in FI2S score |  | 90 days | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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comparison of physical therapy strategies