Clinical trial NCT01544244: The Global Shoulder Concept (GSC) Method Versus Classic Physical Therapy for Shoulder Tendinitis
Official title: Comparison of the Global Shoulder Concept (GSC) Method Versus Classic Physical Therapy for Shoulder Tendinitis: a Prospective, Randomized Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Shoulder
Tendinopathy
Keywords: comparison of physical therapy strategies
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2012-03-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility 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)

Primary outcomes:
measure: change in FI2S score
timeFrame: 90 days
Secondary outcomes:
measure: Change in visual analog scale for pain
timeFrame: Day 1 versus baseline
measure: Change in visual analog scale for pain
timeFrame: Day 5 versus baseline
measure: Change in visual analog scale for pain
timeFrame: Day 12 versus baseline
measure: Change in visual analog scale for pain
timeFrame: Day 19 versus baseline
measure: Change in visual analog scale for pain
timeFrame: Day 26 versus baseline
measure: Change in visual analog scale for pain
timeFrame: Day 90 versus baseline
measure: Scapulohumeral amplitude gain in 3 main directions
timeFrame: Day 1
measure: Scapulohumeral amplitude gain in 3 main directions
timeFrame: Day 26
measure: Scapulohumeral amplitude gain in 3 main directions
timeFrame: Day 90
measure: Functional gain as measured by the DASH self questionnaire
timeFrame: Day 1
measure: Functional gain as measured by the DASH self questionnaire
timeFrame: Day 5
measure: Functional gain as measured by the DASH self questionnaire
timeFrame: Day 12
measure: Functional gain as measured by the DASH self questionnaire
timeFrame: Day 19
measure: Functional gain as measured by the DASH self questionnaire
timeFrame: Day 26
measure: Functional gain as measured by the DASH self questionnaire
timeFrame: Day 90
measure: FI2S score
timeFrame: Day 1
measure: FI2S score
timeFrame: Day 5
measure: FI2S score
timeFrame: Day 12
measure: FI2S score
timeFrame: Day 19
measure: FI2S score
timeFrame: Day 26
measure: SF36 self questionnaire
timeFrame: Day 1
measure: SF36 self questionnaire
timeFrame: Day 26
measure: SF36 self questionnaire
timeFrame: Day 90
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU de Montpellier - Hôpital Lapeyronie
city: Nîmes Cedex 9
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Dominique Richard
role: STUDY_DIRECTOR
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Arnaud Dupeyron, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: