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Register:	ClinicalTrials.gov
Last refreshed on:	13 June 2016
Main ID:	NCT01544244
Date of registration:	23/02/2012
Prospective Registration:	Yes
Primary sponsor:	Centre Hospitalier Universitaire de Nimes
Public title:	The Global Shoulder Concept (GSC) Method Versus Classic Physical Therapy for Shoulder Tendinitis
Scientific title:	Comparison of the Global Shoulder Concept (GSC) Method Versus Classic Physical Therapy for Shoulder Tendinitis: a Prospective, Randomized Study
Date of first enrolment:	October 2012
Target sample size:	40
Recruitment status:	Terminated
URL:	https://clinicaltrials.gov/show/NCT01544244
Study type:	Interventional
Study design:	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase:	N/A

Countries of recruitment
France

Contacts

Name:	Dominique Richard
Address:
Telephone:
Email:
Affiliation:	Centre Hospitalier Universitaire de Nîmes

Name:	Arnaud Dupeyron, MD PhD
Address:
Telephone:
Email:
Affiliation:	Centre Hospitalier Universitaire de Nîmes

Key inclusion & exclusion 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)

Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Shoulder

Tendinopathy

Intervention(s)

Procedure: GSC physical therapy

Procedure: Standard physical therapy

Primary Outcome(s)

change in FI2S score [Time Frame: 90 days]

Secondary Outcome(s)

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 5]

Change in visual analog scale for pain [Time Frame: Day 19 versus baseline]

Change in visual analog scale for pain [Time Frame: Day 90 versus baseline]

FI2S score [Time Frame: Day 19]

Functional gain as measured by the DASH self questionnaire [Time Frame: Day 90]

Change in visual analog scale for pain [Time Frame: Day 12 versus baseline]

FI2S score [Time Frame: Day 12]

Functional gain as measured by the DASH self questionnaire [Time Frame: Day 19]

Scapulohumeral amplitude gain in 3 main directions [Time Frame: Day 90]

Change in visual analog scale for pain [Time Frame: Day 5 versus baseline]

FI2S score [Time Frame: Day 1]

FI2S score [Time Frame: Day 5]

Functional gain as measured by the DASH self questionnaire [Time Frame: Day 1]

Change in visual analog scale for pain [Time Frame: Day 1 versus baseline]

FI2S score [Time Frame: Day 26]

Functional gain as measured by the DASH self questionnaire [Time Frame: Day 26]

Scapulohumeral amplitude gain in 3 main directions [Time Frame: Day 26]

SF36 self questionnaire [Time Frame: Day 90]

SF36 self questionnaire [Time Frame: Day 1]

Change in visual analog scale for pain [Time Frame: Day 26 versus baseline]

Scapulohumeral amplitude gain in 3 main directions [Time Frame: Day 1]

SF36 self questionnaire [Time Frame: Day 26]

Secondary ID(s)

2011-A01168-33

PHRIP/2011/DR-03

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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