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

Primary Purpose

Shoulder, Tendinopathy

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
GSC physical therapy
Standard physical therapy
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder focused on measuring comparison of physical therapy strategies

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • CHU de Montpellier - Hôpital Lapeyronie
  • CHU de Nîmes - Hôpital Universitaire Carémeau

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

GSC physcial therapy

Standard

Arm Description

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

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

Outcomes

Primary Outcome Measures

change in FI2S score

Secondary Outcome Measures

Change in visual analog scale for pain
Change in visual analog scale for pain
Change in visual analog scale for pain
Change in visual analog scale for pain
Change in visual analog scale for pain
Change in visual analog scale for pain
Scapulohumeral amplitude gain in 3 main directions
Passive and active mobility are evaluated by manual goniometry.
Scapulohumeral amplitude gain in 3 main directions
Passive and active mobility are evaluated by manual goniometry.
Scapulohumeral amplitude gain in 3 main directions
Passive and active mobility are evaluated by manual goniometry.
Functional gain as measured by the DASH self questionnaire
Functional gain as measured by the DASH self questionnaire
Functional gain as measured by the DASH self questionnaire
Functional gain as measured by the DASH self questionnaire
Functional gain as measured by the DASH self questionnaire
Functional gain as measured by the DASH self questionnaire
FI2S score
FI2S score
FI2S score
FI2S score
FI2S score
SF36 self questionnaire
SF36 self questionnaire
SF36 self questionnaire

Full Information

First Posted
February 23, 2012
Last Updated
June 2, 2016
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT01544244
Brief Title
The Global Shoulder Concept (GSC) Method Versus Classic Physical Therapy for Shoulder Tendinitis
Official Title
Comparison of the Global Shoulder Concept (GSC) Method Versus Classic Physical Therapy for Shoulder Tendinitis: a Prospective, Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Terminated
Why Stopped
Inclusion curve too slow.
Study Start Date
October 2012 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder, Tendinopathy
Keywords
comparison of physical therapy strategies

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GSC physcial therapy
Arm Type
Experimental
Arm Description
Patients included in this arm of the study will follow the Global Shoulder Concept physical therapy sequence.
Arm Title
Standard
Arm Type
Active Comparator
Arm Description
Patients in this arm of the study will follow the standard physical therapy sequence.
Intervention Type
Procedure
Intervention Name(s)
GSC physical therapy
Intervention Description
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
Intervention Name(s)
Standard physical therapy
Intervention Description
Standard physical therapy sequence for shoulder tendonitis. The procedures used in this protocol refer to physical therapy sequences, not to devices or drugs.
Primary Outcome Measure Information:
Title
change in FI2S score
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Change in visual analog scale for pain
Time Frame
Day 1 versus baseline
Title
Change in visual analog scale for pain
Time Frame
Day 5 versus baseline
Title
Change in visual analog scale for pain
Time Frame
Day 12 versus baseline
Title
Change in visual analog scale for pain
Time Frame
Day 19 versus baseline
Title
Change in visual analog scale for pain
Time Frame
Day 26 versus baseline
Title
Change in visual analog scale for pain
Time Frame
Day 90 versus baseline
Title
Scapulohumeral amplitude gain in 3 main directions
Description
Passive and active mobility are evaluated by manual goniometry.
Time Frame
Day 1
Title
Scapulohumeral amplitude gain in 3 main directions
Description
Passive and active mobility are evaluated by manual goniometry.
Time Frame
Day 26
Title
Scapulohumeral amplitude gain in 3 main directions
Description
Passive and active mobility are evaluated by manual goniometry.
Time Frame
Day 90
Title
Functional gain as measured by the DASH self questionnaire
Time Frame
Day 1
Title
Functional gain as measured by the DASH self questionnaire
Time Frame
Day 5
Title
Functional gain as measured by the DASH self questionnaire
Time Frame
Day 12
Title
Functional gain as measured by the DASH self questionnaire
Time Frame
Day 19
Title
Functional gain as measured by the DASH self questionnaire
Time Frame
Day 26
Title
Functional gain as measured by the DASH self questionnaire
Time Frame
Day 90
Title
FI2S score
Time Frame
Day 1
Title
FI2S score
Time Frame
Day 5
Title
FI2S score
Time Frame
Day 12
Title
FI2S score
Time Frame
Day 19
Title
FI2S score
Time Frame
Day 26
Title
SF36 self questionnaire
Time Frame
Day 1
Title
SF36 self questionnaire
Time Frame
Day 26
Title
SF36 self questionnaire
Time Frame
Day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominique Richard
Organizational Affiliation
Centre Hospitalier Universitaire de Nîmes
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Arnaud Dupeyron, MD PhD
Organizational Affiliation
Centre Hospitalier Universitaire de Nîmes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Montpellier - Hôpital Lapeyronie
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
CHU de Nîmes - Hôpital Universitaire Carémeau
City
Nîmes Cedex 9
ZIP/Postal Code
30029
Country
France

12. IPD Sharing Statement

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

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