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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01544244
First received: February 23, 2012
Last updated: April 18, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Shoulder
Tendinopathy
Procedure: GSC physical therapy
Procedure: Standard physical therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of the Global Shoulder Concept (GSC) Method Versus Classic Physical Therapy for Shoulder Tendinitis: a Prospective, Randomized Study

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • change in FI2S score [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in visual analog scale for pain [ Time Frame: Day 1 versus baseline ] [ Designated as safety issue: Yes ]
  • Change in visual analog scale for pain [ Time Frame: Day 5 versus baseline ] [ Designated as safety issue: Yes ]
  • Change in visual analog scale for pain [ Time Frame: Day 12 versus baseline ] [ Designated as safety issue: Yes ]
  • Change in visual analog scale for pain [ Time Frame: Day 19 versus baseline ] [ Designated as safety issue: Yes ]
  • Change in visual analog scale for pain [ Time Frame: Day 26 versus baseline ] [ Designated as safety issue: Yes ]
  • Change in visual analog scale for pain [ Time Frame: Day 90 versus baseline ] [ Designated as safety issue: Yes ]
  • Scapulohumeral amplitude gain in 3 main directions [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Passive and active mobility are evaluated by manual goniometry.

  • Scapulohumeral amplitude gain in 3 main directions [ Time Frame: Day 26 ] [ Designated as safety issue: No ]
    Passive and active mobility are evaluated by manual goniometry.

  • Scapulohumeral amplitude gain in 3 main directions [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
    Passive and active mobility are evaluated by manual goniometry.

  • Functional gain as measured by the DASH self questionnaire [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Functional gain as measured by the DASH self questionnaire [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
  • Functional gain as measured by the DASH self questionnaire [ Time Frame: Day 12 ] [ Designated as safety issue: No ]
  • Functional gain as measured by the DASH self questionnaire [ Time Frame: Day 19 ] [ Designated as safety issue: No ]
  • Functional gain as measured by the DASH self questionnaire [ Time Frame: Day 26 ] [ Designated as safety issue: No ]
  • Functional gain as measured by the DASH self questionnaire [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
  • FI2S score [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • FI2S score [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
  • FI2S score [ Time Frame: Day 12 ] [ Designated as safety issue: No ]
  • FI2S score [ Time Frame: Day 19 ] [ Designated as safety issue: No ]
  • FI2S score [ Time Frame: Day 26 ] [ Designated as safety issue: No ]
  • SF36 self questionnaire [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • SF36 self questionnaire [ Time Frame: Day 26 ] [ Designated as safety issue: No ]
  • SF36 self questionnaire [ Time Frame: Day 90 ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: October 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01544244

Contacts
Contact: Dominique Richard +33.(0)4.66.68.34.60 dominique.richard@chu-nimes.fr
Contact: Carey M Suehs, PhD +33.(0)4.66.68.67.88 carey.suehs@chu-nimes.fr

Locations
France
CHU de Montpellier - Hôpital Lapeyronie Recruiting
Montpellier, France, 34295
Sub-Investigator: Isabelle Tavares, MD         
Sub-Investigator: Catherine Bataille         
Sub-Investigator: Marc Julia, MD         
Sub-Investigator: Céline Grosjean, MD         
Sub-Investigator: Isabelle Laffont, MD, PhD         
Sub-Investigator: Yaelle Van Raay, MD         
Sub-Investigator: Matthieu Vaucher, MD         
CHU de Nîmes - Hôpital Universitaire Carémeau Recruiting
Nîmes Cedex 9, France, 30029
Principal Investigator: Arnaud Dupeyron, MD PhD         
Sub-Investigator: Dominique Richard         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Study Director: Dominique Richard Centre Hospitalier Universitaire de Nîmes
Principal Investigator: Arnaud Dupeyron, MD PhD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01544244     History of Changes
Other Study ID Numbers: PHRIP/2011/DR-03, 2011-A01168-33
Study First Received: February 23, 2012
Last Updated: April 18, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
comparison of physical therapy strategies

Additional relevant MeSH terms:
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on July 23, 2014