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

NCT01544244 | Terminated

• 2 other identifiers: PHRIP/2011/DR-032011-A01168-33
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Shoulder; Tendinopathy

Keywords

comparison of physical therapy strategies

Outcome Measures

Primary Outcomes (1)

• change in FI2S score

  90 days

Secondary Outcomes (23)

• 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

Study Arms (2)

GSC physcial therapy

EXPERIMENTAL

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

Procedure: GSC physical therapy

Standard

ACTIVE COMPARATOR

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

Procedure: Standard physical therapy

Interventions

GSC physical therapy 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.

GSC physcial therapy

Standard physical therapy PROCEDURE

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

Standard

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (2)

CHU de Montpellier - Hôpital Lapeyronie

Montpellier, 34295, France

Location

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Tendinopathy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries

Study Officials

• Dominique Richard

  Centre Hospitalier Universitaire de Nîmes

  STUDY DIRECTOR

• Arnaud Dupeyron, MD PhD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2012
• First Posted: March 5, 2012
• Study Start: October 1, 2012
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: June 3, 2016

Record last verified: 2016-06

Locations

FR (2)