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

Tendinopathy Clinical Trial

Official title:

Comparison of the Global Shoulder Concept (GSC) Method Versus Classic Physical Therapy for Shoulder Tendinitis: a Prospective, Randomized Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01544244
• Other study ID #: PHRIP/2011/DR-03
• Secondary ID: 2011-A01168-33
• Status: Terminated
• Phase: N/A
• First received: February 23, 2012
• Last updated: June 2, 2016
• Start date: October 2012
• Est. completion date: May 2016

Study information

• Verified date: June 2016
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Shoulder
• Tendinopathy

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	CHU de Montpellier - Hôpital Lapeyronie	Montpellier
France	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 9

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in FI2S score		90 days	No
Secondary	Change in visual analog scale for pain		Day 1 versus baseline	Yes
Secondary	Change in visual analog scale for pain		Day 5 versus baseline	Yes
Secondary	Change in visual analog scale for pain		Day 12 versus baseline	Yes
Secondary	Change in visual analog scale for pain		Day 19 versus baseline	Yes
Secondary	Change in visual analog scale for pain		Day 26 versus baseline	Yes
Secondary	Change in visual analog scale for pain		Day 90 versus baseline	Yes
Secondary	Scapulohumeral amplitude gain in 3 main directions	Passive and active mobility are evaluated by manual goniometry.	Day 1	No
Secondary	Scapulohumeral amplitude gain in 3 main directions	Passive and active mobility are evaluated by manual goniometry.	Day 26	No
Secondary	Scapulohumeral amplitude gain in 3 main directions	Passive and active mobility are evaluated by manual goniometry.	Day 90	No
Secondary	Functional gain as measured by the DASH self questionnaire		Day 1	No
Secondary	Functional gain as measured by the DASH self questionnaire		Day 5	No
Secondary	Functional gain as measured by the DASH self questionnaire		Day 12	No
Secondary	Functional gain as measured by the DASH self questionnaire		Day 19	No
Secondary	Functional gain as measured by the DASH self questionnaire		Day 26	No
Secondary	Functional gain as measured by the DASH self questionnaire		Day 90	No
Secondary	FI2S score		Day 1	No
Secondary	FI2S score		Day 5	No
Secondary	FI2S score		Day 12	No
Secondary	FI2S score		Day 19	No
Secondary	FI2S score		Day 26	No
Secondary	SF36 self questionnaire		Day 1	No
Secondary	SF36 self questionnaire		Day 26	No
Secondary	SF36 self questionnaire		Day 90	No