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TerminatedNCT01544244Updated Jun 3, 2016

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

An interventional study of GSC physical therapy and Standard physical therapy in Shoulder and Tendinopathy, sponsored by Centre Hospitalier Universitaire de Nīmes. Terminated at 2 sites in France. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-06-03.

Sponsored by Centre Hospitalier Universitaire de Nīmes · Not applicable, Interventional, and Treatment

Why this study was terminated
Inclusion curve too slow.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Shoulder
  • Tendinopathy

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Keywords

  • comparison of physical therapy strategies
03

In context

Tendinopathy

413 studies on the registry are indexed under Tendinopathy; 64 are open to participants now.

This study's enrollment of 40 is below the median of 50 across 339 interventional studies indexed under Tendinopathy.

Browse Tendinopathy studies →

Lead sponsor

Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 587 studies on the registry; 96 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
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

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • 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

  • Active comparator
    Standard

    Patients in this arm of the study will follow the standard physical therapy sequence.

    Procedure: Standard physical therapy

Interventions

  • ProcedureGSC 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.

  • ProcedureStandard 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.

06

What researchers measure

Primary outcomes

  1. change in FI2S score

    Time frame: 90 days

Secondary outcomes

  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

    Passive and active mobility are evaluated by manual goniometry.

    Time frame: Day 1

  8. Scapulohumeral amplitude gain in 3 main directions

    Passive and active mobility are evaluated by manual goniometry.

    Time frame: Day 26

  9. Scapulohumeral amplitude gain in 3 main directions

    Passive and active mobility are evaluated by manual goniometry.

    Time frame: Day 90

  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

07

Study locations

2 sites
  • CHU de Montpellier - Hôpital Lapeyronie
    Montpellier, 34295, France
  • CHU de Nîmes - Hôpital Universitaire Carémeau
    Nîmes Cedex 9, 30029, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01544244
Lead sponsor
Centre Hospitalier Universitaire de Nīmes
Responsible party
Sponsor
First posted
Mar 5, 2012
Start date
Oct 2012
Primary completion
May 2016
Completion
May 2016
Last update
Jun 3, 2016

Study contacts

Dominique Richard
study director · Centre Hospitalier Universitaire de Nîmes
Arnaud Dupeyron, MD PhD
principal investigator · Centre Hospitalier Universitaire de Nîmes

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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