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

NCT ID: NCT01544244

Last Updated: 2016-06-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2016-05-31

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.

Conditions

Shoulder; Tendinopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GSC physcial therapy

Patients included in this arm of the study will follow the Global Shoulder Concept physical therapy sequence.

Group Type: EXPERIMENTAL

GSC physical therapy

Intervention Type: PROCEDURE

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

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

Group Type: ACTIVE_COMPARATOR

Standard physical therapy

Intervention Type: PROCEDURE

Standard physical therapy sequence for shoulder tendonitis. The procedures used in this protocol refer to physical therapy sequences, not to devices or drugs.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dominique Richard

Role: STUDY_DIRECTOR

Centre Hospitalier Universitaire de Nîmes

Arnaud Dupeyron, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

CHU de Montpellier - Hôpital Lapeyronie

Montpellier, , France

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, , France

Countries

France

Other Identifiers

2011-A01168-33

Identifier Type: OTHER

Identifier Source: secondary_id

PHRIP/2011/DR-03

Identifier Type: -

Identifier Source: org_study_id