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.

Study Overview

• Status: Terminated
• Conditions: Tendinopathy; Shoulder
• Intervention / Treatment: Procedure: GSC physical therapy; Procedure: Standard physical therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • CHU de Montpellier - Hôpital Lapeyronie
  • Nîmes Cedex 9, France, 30029
    • CHU de Nimes - Hopital Universitaire Caremeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.
ACTIVE_COMPARATOR: Standard; Patients in this arm of the study will follow the standard physical therapy sequence.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
change in FI2S score	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in visual analog scale for pain		Day 1 versus baseline
Change in visual analog scale for pain		Day 5 versus baseline
Change in visual analog scale for pain		Day 12 versus baseline
Change in visual analog scale for pain		Day 19 versus baseline
Change in visual analog scale for pain		Day 26 versus baseline
Change in visual analog scale for pain		Day 90 versus baseline
Scapulohumeral amplitude gain in 3 main directions	Passive and active mobility are evaluated by manual goniometry.	Day 1
Scapulohumeral amplitude gain in 3 main directions	Passive and active mobility are evaluated by manual goniometry.	Day 26
Scapulohumeral amplitude gain in 3 main directions	Passive and active mobility are evaluated by manual goniometry.	Day 90
Functional gain as measured by the DASH self questionnaire		Day 1
Functional gain as measured by the DASH self questionnaire		Day 5
Functional gain as measured by the DASH self questionnaire		Day 12
Functional gain as measured by the DASH self questionnaire		Day 19
Functional gain as measured by the DASH self questionnaire		Day 26
Functional gain as measured by the DASH self questionnaire		Day 90
FI2S score		Day 1
FI2S score		Day 5
FI2S score		Day 12
FI2S score		Day 19
FI2S score		Day 26
SF36 self questionnaire		Day 1
SF36 self questionnaire		Day 26
SF36 self questionnaire		Day 90

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Study Director: Dominique Richard, Centre Hospitalier Universitaire de Nîmes

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (ACTUAL): May 1, 2016
• Study Completion (ACTUAL): May 1, 2016

Study Registration Dates

• First Submitted: February 23, 2012
• First Submitted That Met QC Criteria: March 2, 2012
• First Posted (ESTIMATE): March 5, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): June 3, 2016
• Last Update Submitted That Met QC Criteria: June 2, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: comparison of physical therapy strategies
• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy
• Other Study ID Numbers: PHRIP/2011/DR-03; 2011-A01168-33 (OTHER: RCB number)