The Global Shoulder Concept (GSC) Method Versus Classic Physical Therapy for Shoulder Tendinitis
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ClinicalTrials.gov Identifier: NCT01544244 |
Recruitment Status
:
Terminated
(Inclusion curve too slow.)
First Posted
: March 5, 2012
Last Update Posted
: June 3, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Shoulder Tendinopathy | Procedure: GSC physical therapy Procedure: Standard physical therapy | Not Applicable |
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 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 |

Arm | Intervention/treatment |
---|---|
Experimental: GSC physcial therapy
Patients included in this arm of the study will follow the Global Shoulder Concept physical therapy sequence.
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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.
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Active Comparator: Standard
Patients in this arm of the study will follow the standard physical therapy sequence.
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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.
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- change in FI2S score [ Time Frame: 90 days ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01544244
France | |
CHU de Montpellier - Hôpital Lapeyronie | |
Montpellier, France, 34295 | |
CHU de Nîmes - Hôpital Universitaire Carémeau | |
Nîmes Cedex 9, France, 30029 |
Study Director: | Dominique Richard | Centre Hospitalier Universitaire de Nîmes | |
Principal Investigator: | Arnaud Dupeyron, MD PhD | Centre Hospitalier Universitaire de Nîmes |
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 Key Record Dates |
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 |