ShoulderNCT01544244
The Global Shoulder Concept (GSC) Method Versus Classic Physical Therapy for Shoulder Tendinitis
A study testing GSC physical therapy and Standard physical therapy in people with Shoulder and Tendinopathy, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Shoulder, Tendinopathy
- What is being tested?
- GSC physical therapy and Standard physical therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesFrance
- Study dates
- Oct 2012to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU de Montpellier - Hôpital Lapeyronie
Montpellier, 34295
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029
About this study
Official title: Comparison of the Global Shoulder Concept (GSC) Method Versus Classic Physical Therapy for Shoulder Tendinitis: a Prospective, Randomized Study
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.
Read the 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
- Being tested
- GSC physical therapy, Standard physical therapy
- Keywords
- comparison of physical therapy strategies
- Medical subject headings
- Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSC physical therapyProcedure or surgery
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 physical therapyProcedure or surgery
Standard physical therapy sequence for shoulder tendonitis. The procedures used in this protocol refer to physical therapy sequences, not to devices or drugs.
| Study group | Role | What they receive |
|---|---|---|
| GSC physcial therapy | Experimental | Patients included in this arm of the study will follow the Global Shoulder Concept physical therapy sequence. Receives: Procedure: GSC physical therapy |
| Standard | Active comparator | Patients in this arm of the study will follow the standard physical therapy sequence. Receives: Procedure: Standard physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in FI2S score
Measured: 90 days
Secondary outcomes (23)
Change in visual analog scale for pain
Measured: Day 1 versus baseline
Change in visual analog scale for pain
Measured: Day 5 versus baseline
Change in visual analog scale for pain
Measured: Day 12 versus baseline
Change in visual analog scale for pain
Measured: Day 19 versus baseline
Change in visual analog scale for pain
Measured: Day 26 versus baseline
Change in visual analog scale for pain
Measured: Day 90 versus baseline
Scapulohumeral amplitude gain in 3 main directions
Passive and active mobility are evaluated by manual goniometry.
Measured: Day 1
Scapulohumeral amplitude gain in 3 main directions
Passive and active mobility are evaluated by manual goniometry.
Measured: Day 26
Scapulohumeral amplitude gain in 3 main directions
Passive and active mobility are evaluated by manual goniometry.
Measured: Day 90
Functional gain as measured by the DASH self questionnaire
Measured: Day 1
Functional gain as measured by the DASH self questionnaire
Measured: Day 5
Functional gain as measured by the DASH self questionnaire
Measured: Day 12
Functional gain as measured by the DASH self questionnaire
Measured: Day 19
Functional gain as measured by the DASH self questionnaire
Measured: Day 26
Functional gain as measured by the DASH self questionnaire
Measured: Day 90
FI2S score
Measured: Day 1
FI2S score
Measured: Day 5
FI2S score
Measured: Day 12
FI2S score
Measured: Day 19
FI2S score
Measured: Day 26
SF36 self questionnaire
Measured: Day 1
SF36 self questionnaire
Measured: Day 26
SF36 self questionnaire
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2012 (estimated)
- Study startOct 2012
- Primary completionMay 2016
- Study completionMay 2016
Why it stopped: Inclusion curve too slow.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShoulderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominique Richard, Study director, Centre Hospitalier Universitaire de NīmesArnaud Dupeyron, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01544244
- Sponsor's protocol ID
- PHRIP/2011/DR-03
- Other IDs
- 2011-A01168-33
- Status last verified
- Jun 2016
- First submitted
- 23 Feb 2012
- Last updated
- 3 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Global Shoulder Concept (GSC) Method Versus Classic Physical Therapy for Shoulder Tendinitis: a Prospective, Randomized Study
- ClinicalTrials.gov ID
- NCT01544244
- Acronym / sponsor ID
- PHRIP/2011/DR-03
- Conditions
- Shoulder, Tendinopathy
- Keywords
- comparison of physical therapy strategies
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inclusion curve too slow.
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 5 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GSC physcial therapy | Experimental | Procedure: GSC physical therapyPatients included in this arm of the study will follow the Global Shoulder Concept physical therapy sequence. |
| Standard | Active comparator | Procedure: Standard physical therapyPatients in this arm of the study will follow the standard physical therapy sequence. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GSC physical therapyGlobal Shoulder Concept physical therapy sequence for shoulder tendonitis. The procedures used in this protocol refer to physical therapy sequences, not to devices or drugs. | Procedure or surgery | GSC physcial therapy |
| Standard physical therapyStandard physical therapy sequence for shoulder tendonitis. The procedures used in this protocol refer to physical therapy sequences, not to devices or drugs. | Procedure or surgery | Standard |
Primary outcome
change in FI2S score
Time frame: 90 days
23 secondary outcomes
Change in visual analog scale for pain
Time frame: Day 1 versus baseline
Change in visual analog scale for pain
Time frame: Day 5 versus baseline
Change in visual analog scale for pain
Time frame: Day 12 versus baseline
Change in visual analog scale for pain
Time frame: Day 19 versus baseline
Change in visual analog scale for pain
Time frame: Day 26 versus baseline
Change in visual analog scale for pain
Time frame: Day 90 versus baseline
Scapulohumeral amplitude gain in 3 main directions
Time frame: Day 1
Scapulohumeral amplitude gain in 3 main directions
Time frame: Day 26
Scapulohumeral amplitude gain in 3 main directions
Time frame: Day 90
Functional gain as measured by the DASH self questionnaire
Time frame: Day 1
Functional gain as measured by the DASH self questionnaire
Time frame: Day 5
Functional gain as measured by the DASH self questionnaire
Time frame: Day 12
Functional gain as measured by the DASH self questionnaire
Time frame: Day 19
Functional gain as measured by the DASH self questionnaire
Time frame: Day 26
Functional gain as measured by the DASH self questionnaire
Time frame: Day 90
FI2S score
Time frame: Day 1
FI2S score
Time frame: Day 5
FI2S score
Time frame: Day 12
FI2S score
Time frame: Day 19
FI2S score
Time frame: Day 26
SF36 self questionnaire
Time frame: Day 1
SF36 self questionnaire
Time frame: Day 26
SF36 self questionnaire
Time frame: Day 90
Results and safety
The study was stopped early (reason given: Inclusion curve too slow.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominique Richard study director
Centre Hospitalier Universitaire de Nīmes
Arnaud Dupeyron, MD PhD principal investigator
Centre Hospitalier Universitaire de Nīmes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GSC physical therapy and Standard physical therapy in people with Shoulder and Tendinopathy, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Inclusion curve too slow.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in FI2S score (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2016.