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

This study has been terminated.
(Inclusion curve too slow.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01544244
First Posted: March 5, 2012
Last Update Posted: June 3, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
February 23, 2012
March 5, 2012
June 3, 2016
October 2012
May 2016   (Final data collection date for primary outcome measure)
change in FI2S score [ Time Frame: 90 days ]
change in FI2S score [ Time Frame: 90 days versus baseline ]
Complete list of historical versions of study NCT01544244 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 versus baseline ]
    Passive and active mobility are evaluated by manual goniometry.
  • Scapulohumeral amplitude gain in 3 main directions [ Time Frame: Day 5 versus baseline ]
    Passive and active mobility are evaluated by manual goniometry.
  • Scapulohumeral amplitude gain in 3 main directions [ Time Frame: Day 12 versus baseline ]
    Passive and active mobility are evaluated by manual goniometry.
  • Scapulohumeral amplitude gain in 3 main directions [ Time Frame: Day 19 versus baseline ]
    Passive and active mobility are evaluated by manual goniometry.
  • Scapulohumeral amplitude gain in 3 main directions [ Time Frame: Day 26 versus baseline ]
    Passive and active mobility are evaluated by manual goniometry.
  • Scapulohumeral amplitude gain in 3 main directions [ Time Frame: Day 90 versus baseline ]
    Passive and active mobility are evaluated by manual goniometry.
  • Functional gain as measured by the DASH self questionnaire [ Time Frame: Day 1 versus baseline ]
  • Functional gain as measured by the DASH self questionnaire [ Time Frame: Day 5 versus baseline ]
  • Functional gain as measured by the DASH self questionnaire [ Time Frame: Day 12 versus baseline ]
  • Functional gain as measured by the DASH self questionnaire [ Time Frame: Day 19 versus baseline ]
  • Functional gain as measured by the DASH self questionnaire [ Time Frame: Day 26 versus baseline ]
  • Functional gain as measured by the DASH self questionnaire [ Time Frame: Day 90 versus baseline ]
  • FI2S score [ Time Frame: Day 1 versus baseline ]
  • FI2S score [ Time Frame: Day 5 versus baseline ]
  • FI2S score [ Time Frame: Day 12 versus baseline ]
  • FI2S score [ Time Frame: Day 19 versus baseline ]
  • FI2S score [ Time Frame: Day 26 versus baseline ]
  • SF36 self questionnaire [ Time Frame: Day 1 versus baseline ]
  • SF36 self questionnaire [ Time Frame: Day 26 versus baseline ]
  • SF36 self questionnaire [ Time Frame: Day 90 versus baseline ]
Not Provided
Not Provided
 
The Global Shoulder Concept (GSC) Method Versus Classic Physical Therapy for Shoulder Tendinitis
Comparison of the Global Shoulder Concept (GSC) Method Versus Classic Physical Therapy for Shoulder Tendinitis: a Prospective, Randomized Study
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.

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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Shoulder
  • Tendinopathy
  • 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.
  • 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.
  • Experimental: GSC physcial therapy
    Patients included in this arm of the study will follow the Global Shoulder Concept physical therapy sequence.
    Intervention: Procedure: GSC physical therapy
  • Active Comparator: Standard
    Patients in this arm of the study will follow the standard physical therapy sequence.
    Intervention: Procedure: Standard physical therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
40
May 2016
May 2016   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01544244
PHRIP/2011/DR-03
2011-A01168-33 ( Other Identifier: RCB number )
No
Not Provided
Not Provided
Centre Hospitalier Universitaire de Nīmes
Centre Hospitalier Universitaire de Nīmes
Not Provided
Study Director: Dominique Richard Centre Hospitalier Universitaire de Nîmes
Principal Investigator: Arnaud Dupeyron, MD PhD Centre Hospitalier Universitaire de Nîmes
Centre Hospitalier Universitaire de Nīmes
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP