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

Sponsor

Centre Hospitalier Universitaire de Nīmes (Other)

Overall Status

Terminated

CT.gov ID

NCT01544244

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Shoulder Tendinopathy	Procedure: GSC physical therapy Procedure: Standard physical therapy	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Oct 1, 2012

Actual Primary Completion Date :

May 1, 2016

Actual Study Completion Date :

May 1, 2016

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

change in FI2S score [90 days]

Secondary Outcome Measures

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 [Day 1]
Passive and active mobility are evaluated by manual goniometry.
Scapulohumeral amplitude gain in 3 main directions [Day 26]
Passive and active mobility are evaluated by manual goniometry.
Scapulohumeral amplitude gain in 3 main directions [Day 90]
Passive and active mobility are evaluated by manual goniometry.
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	CHU de Montpellier - Hôpital Lapeyronie	Montpellier		France	34295
2	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 9		France	30029

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Nīmes

ClinicalTrials.gov Identifier:

NCT01544244

Other Study ID Numbers:

PHRIP/2011/DR-03
2011-A01168-33

First Posted:

Mar 5, 2012

Last Update Posted:

Jun 3, 2016

Last Verified:

Jun 1, 2016

Keywords provided by Centre Hospitalier Universitaire de Nīmes

comparison of physical therapy strategies

Additional relevant MeSH terms:

Tendinopathy

Study Results

No Results Posted as of Jun 3, 2016