Subacromial Impingement of the ShoulderSCAPULEONCT02874105
Glenohumeral Re-centering During Closed Kinetic Chain for Shoulder Physiotherapy. A Prospective and Randomized Study.
A study testing Group C: physiotherapy protocol with Conventional physiotherapy. and Group S: physiotherapy protocol with Dynamic Humeral Centering. in people with Subacromial Impingement of the Shoulder, run by CHU de Reims at 1 site in France.
Trial summary
The rotator cuff tendinopathy is very common and associated with degenerative or traumatic changes of the rotator cuff and/or the sub-acromial bursa or the long head of the biceps. Lesions go of the simple tendinopathy without tear to the full-thickness tear of the cuff which means a loss of mobility or strength. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subacromial Impingement of the Shoulder
- What is being tested?
- Group C: physiotherapy protocol with Conventional physiotherapy. and Group S: physiotherapy protocol with Dynamic Humeral Centering.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 30 Aug 2016to 26 Feb 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Painful shoulder causes by tendinopathy of the rotator cuff (without full-thickness tear)
- Diagnosis based on a MRI (dating less than 6 months)
Who cannot join
- Tendinopathy of the rotator cuff with full-thickness tear
- Stiffness of the shoulder (loss of more than 20° in passive external rotation or passive forward elevation)
- Previous shoulder surgery (less than 12 months)
- Previous subacromial injection (less than 6 months)
- Context of worker's compensation claims
Trial locations and contacts
1 site in 1 country.
About this study
The rotator cuff tendinopathy is very common and associated with degenerative or traumatic changes of the rotator cuff and/or the sub-acromial bursa or the long head of the biceps. Lesions go of the simple tendinopathy without tear to the full-thickness tear of the cuff which means a loss of mobility or strength. The origin of this pathology remains controversial and many causes have been evoked (subacromial mechanical impingement, degenerative changes, muscle imbalance…). The clinical impairment is not always the same and varies from a painful shoulder with correct range of motion to a pseudoparalysis shoulder. The first treatment of the rotator cuff pathology is always non surgical and consists in relative resting, painkillers and/or non-steroidal anti-inflammatory drugs (NSAD) and physiotherapy. The aim of this management is to relieve pain and to restore the mobility and a good function of the shoulder.
There is no consensus about the physiotherapy protocol for the treatment of the rotator cuff tendinopathy. In France, the most used physiotherapy protocol uses the strengthening of the muscles which stabilize the scapula (rhomboide muscles, trapezius and serratus anterior) and which lower the humerus (pectoralis major, latissimus dorsi and teres major). The aim of this approach is to augment the subacromial space in order to decrease the inflammation of the rotator cuff tendons and the associated pain. A technique of Dynamic Humeral Centering (DHC) uses a new method of glenohumeral centering in closed kinetic chain has been described ("3C Concept" for Centering in a Closed Chain). Dynamic humeral centring (DHC) is a modality of physiotherapy that aims to prevent subacromial impingement of rotator cuff tendons. In order to simplify and to improve its reliability, a special device called Scapuleo® has been developed. The aim of this device is to help the physiotherapist to realize simultaneously a subacromial decompression, a specific strengthening of the rotator cuff muscles and an optimal activation of the lower trapezius and the anterior serratus.
Read more
Our hypothesis was that the DHC was not inferior to the conventional physiotherapy protocol for the medical treatment of the rotator cuff tendinopathy without full-thickness tear.
We proposed a prospective and randomized study. All the patients treated in our department for simple tendinopathy of the rotator cuff or partial thickness tear were included in this study after signed consent. The physiotherapy protocol consists in 20 sessions of either "Conventional program" (Control group) or "Dynamic Humeral Centering" (Study group). The clinical evaluation included the range of motion measurement, Constant Score, Quick-DASH and Oxford Shoulder Score at 3 months and 6 months. Patients were blinded to the study hypothesis. The assessor of all outcomes was blinded to the interventions.
Read the detailed description
Shoulder impingement accounts for 44 to 65% of shoulder complaints during physician visits. Shoulder impingement has been classified into two main categories: structural and functional. The structural impingement can be caused by narrowing of the subacromial space resulting from a reduction in the space due to bony growth or soft-tissue inflammation. The functional impingement or superior migration of the humeral head can be caused by weakness and/or muscle imbalance. It is possible that some subacromial impingement results from a combination of both structural and functional factors. Subacromial impingement occurs when the structures in the SAS (rotator cuff, biceps tendon long head, and subacromial bursa) become compressed and inflamed under the coracoacromial ligament. The suprasinatus tendon in particular is at highest risk for irritation and subsequent injury because it is the most likely to contact the acromion when the humerus is abducted to 90° and internally rotated 45°.
The clinical impairment is not always the same and varies from a painful shoulder with correct range of motion to a pseudoparalysis shoulder. The first treatment of this subacromial impingement is always non surgical and consists in relative resting, painkillers and/or non-steroidal anti-inflammatory drugs (NSAD) and physiotherapy. The aim of this treatment is to relieve pain and to restore the mobility and a good function of the shoulder.
There is no consensus about the physiotherapy protocol for the treatment of the shoulder impingement. In France, the most used physiotherapy protocol uses the strengthening of the muscles which stabilize the scapula (rhomboide muscles, trapezius and serratus anterior) and which lower the humerus (pectoralis major, latissimus dorsi and teres major). The aim of this approach is to augment the subacromial space in order to decrease the inflammation of the rotator cuff tendons and the associated pain. A technique of Dynamic Humeral Centering (DHC) uses a new method of glenohumeral centering in closed kinetic chain has been described ("3C Concept" for Centering in a Closed Chain). Dynamic humeral centring (DHC) is a modality of physiotherapy that aims to prevent subacromial impingement of rotator cuff tendons. In order to simplify and to improve its reliability, a special device called Scapuleo® has been developed. The aim of this device is to help the physiotherapist to realize simultaneously a subacromial decompression, a specific strengthening of the rotator cuff muscles and an optimal activation of the lower trapezius and the anterior serratus.
Our hypothesis was that the DHC was not inferior to the conventional physiotherapy protocol for the medical treatment of the subacromial impingement.
We proposed a prospective and randomized study. All the patients treated in our department for simple tendinopathy of the rotator cuff or partial thickness tear were included in this study after signed consent. The physiotherapy protocol consisted in 20 sessions of either "Conventional program" (Control group) or "Dynamic Humeral Centering" (Study group). The clinical evaluation included the range of motion measurement, Constant Score, Quick-DASH and Oxford Shoulder Score at 3 months and 6 months. Patients were blinded to the study hypothesis. The assessor of all outcomes was blinded to the interventions.
The rhythm of the physiotherapy sessions was the same in both groups (3 sessions per week for 3 weeks, 2 sessions per week for 3 weeks and 1 session per week for 5 weeks). All patients received passive mobilization of the shoulder without pain and muscle stretching. Each physiotherapy session lasted 30 minutes and included massage or hot physiotherapy in case of VAS (visual analogic scale) of pain superior to 6/10.
- Conditions
- Subacromial Impingement of the Shoulder
- Being tested
- Group C: physiotherapy protocol with Conventional physiotherapy., Group S: physiotherapy protocol with Dynamic Humeral Centering.
- Keywords
- Medical treatment, physiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group C: physiotherapy protocol with Conventional physiotherapy.Other
Group S: physiotherapy protocol with Dynamic Humeral Centering.Other
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Dynamic Humeral Centering Receives: Other: Group S: physiotherapy protocol with Dynamic Humeral Centering. |
| control group | Active comparator | Conventional physiotherapy Receives: Other: Group C: physiotherapy protocol with Conventional physiotherapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional status of the shoulder
Functional status of the shoulder evaluated using the Constant \& Murley Score
Measured: 6 months
Secondary outcomes (7)
Functional status of the shoulder
Functional status of the shoulder evaluated using the Constant \& Murley Score
Measured: 3 months
Disabilities of the Arm, Shoulder and Hand score
Disabilities of the Arm, Shoulder and Hand score evaluated using the Quick-DASH (short form), self reported questionnaire (12 questions)
Measured: 3 months
Disabilities of the Arm, Shoulder and Hand score
Disabilities of the Arm, Shoulder and Hand score evaluated using the Quick-DASH (short form), self reported questionnaire (12 questions)
Measured: 6 months
Functional status of the shoulder
Functional status of the shoulder evaluated using Oxford Shoulder Score, self reported questionnaire (12 questions)
Measured: 3 months
Functional status of the shoulder
Functional status of the shoulder evaluated using Oxford Shoulder Score, self reported questionnaire (12 questions)
Measured: 6 months
pain
Shoulder pain evaluated using a visual analogic pain scale
Measured: 3 months
pain
Shoulder pain evaluated using a visual analogic pain scale
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2016 (estimated)
- Study start30 Aug 2016
- Primary completion21 May 2019
- Study completion26 Feb 2021
Why it stopped: Difficulties for enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subacromial Impingement of the ShoulderStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02874105
- Sponsor's protocol ID
- PO16022*
- Acronym
- SCAPULEO
- Status last verified
- May 2021
- First submitted
- 11 Aug 2016
- Last updated
- 13 May 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glenohumeral Re-centering During Closed Kinetic Chain for Shoulder Physiotherapy. A Prospective and Randomized Study.
- ClinicalTrials.gov ID
- NCT02874105
- Acronym / sponsor ID
- SCAPULEO / PO16022*
- Conditions
- Subacromial Impingement of the Shoulder
- Keywords
- Medical treatment, physiotherapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties for enrollment
- Enrolment
- 24 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 30 Aug 2016 (actual)
- Primary completion
- 21 May 2019 (actual)
- Study completion
- 26 Feb 2021 (actual)
- First posted
- 22 Aug 2016 (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 rotator cuff tendinopathy is very common and associated with degenerative or traumatic changes of the rotator cuff and/or the sub-acromial bursa or the long head of the biceps. Lesions go of the simple tendinopathy without tear to the full-thickness tear of the cuff which means a loss of mobility or strength. The origin of this pathology remains controversial and many causes have been evoked (subacromial mechanical impingement, degenerative changes, muscle imbalance…). The clinical impairment is not always the same and varies from a painful shoulder with correct range of motion to a pseudoparalysis shoulder. The first treatment of the rotator cuff pathology is always non surgical and consists in relative resting, painkillers and/or non-steroidal anti-inflammatory drugs (NSAD) and physiotherapy. The aim of this management is to relieve pain and to restore the mobility and a good function of the shoulder.
There is no consensus about the physiotherapy protocol for the treatment of the rotator cuff tendinopathy. In France, the most used physiotherapy protocol uses the strengthening of the muscles which stabilize the scapula (rhomboide muscles, trapezius and serratus anterior) and which lower the humerus (pectoralis major, latissimus dorsi and teres major). The aim of this approach is to augment the subacromial space in order to decrease the inflammation of the rotator cuff tendons and the associated pain. A technique of Dynamic Humeral Centering (DHC) uses a new method of glenohumeral centering in closed kinetic chain has been described ("3C Concept" for Centering in a Closed Chain). Dynamic humeral centring (DHC) is a modality of physiotherapy that aims to prevent subacromial impingement of rotator cuff tendons. In order to simplify and to improve its reliability, a special device called Scapuleo® has been developed. The aim of this device is to help the physiotherapist to realize simultaneously a subacromial decompression, a specific strengthening of the rotator cuff muscles and an optimal activation of the lower trapezius and the anterior serratus.
Our hypothesis was that the DHC was not inferior to the conventional physiotherapy protocol for the medical treatment of the rotator cuff tendinopathy without full-thickness tear.
We proposed a prospective and randomized study. All the patients treated in our department for simple tendinopathy of the rotator cuff or partial thickness tear were included in this study after signed consent. The physiotherapy protocol consists in 20 sessions of either "Conventional program" (Control group) or "Dynamic Humeral Centering" (Study group). The clinical evaluation included the range of motion measurement, Constant Score, Quick-DASH and Oxford Shoulder Score at 3 months and 6 months. Patients were blinded to the study hypothesis. The assessor of all outcomes was blinded to the interventions.
Detailed description
Shoulder impingement accounts for 44 to 65% of shoulder complaints during physician visits. Shoulder impingement has been classified into two main categories: structural and functional. The structural impingement can be caused by narrowing of the subacromial space resulting from a reduction in the space due to bony growth or soft-tissue inflammation. The functional impingement or superior migration of the humeral head can be caused by weakness and/or muscle imbalance. It is possible that some subacromial impingement results from a combination of both structural and functional factors. Subacromial impingement occurs when the structures in the SAS (rotator cuff, biceps tendon long head, and subacromial bursa) become compressed and inflamed under the coracoacromial ligament. The suprasinatus tendon in particular is at highest risk for irritation and subsequent injury because it is the most likely to contact the acromion when the humerus is abducted to 90° and internally rotated 45°.
The clinical impairment is not always the same and varies from a painful shoulder with correct range of motion to a pseudoparalysis shoulder. The first treatment of this subacromial impingement is always non surgical and consists in relative resting, painkillers and/or non-steroidal anti-inflammatory drugs (NSAD) and physiotherapy. The aim of this treatment is to relieve pain and to restore the mobility and a good function of the shoulder.
There is no consensus about the physiotherapy protocol for the treatment of the shoulder impingement. In France, the most used physiotherapy protocol uses the strengthening of the muscles which stabilize the scapula (rhomboide muscles, trapezius and serratus anterior) and which lower the humerus (pectoralis major, latissimus dorsi and teres major). The aim of this approach is to augment the subacromial space in order to decrease the inflammation of the rotator cuff tendons and the associated pain. A technique of Dynamic Humeral Centering (DHC) uses a new method of glenohumeral centering in closed kinetic chain has been described ("3C Concept" for Centering in a Closed Chain). Dynamic humeral centring (DHC) is a modality of physiotherapy that aims to prevent subacromial impingement of rotator cuff tendons. In order to simplify and to improve its reliability, a special device called Scapuleo® has been developed. The aim of this device is to help the physiotherapist to realize simultaneously a subacromial decompression, a specific strengthening of the rotator cuff muscles and an optimal activation of the lower trapezius and the anterior serratus.
Our hypothesis was that the DHC was not inferior to the conventional physiotherapy protocol for the medical treatment of the subacromial impingement.
We proposed a prospective and randomized study. All the patients treated in our department for simple tendinopathy of the rotator cuff or partial thickness tear were included in this study after signed consent. The physiotherapy protocol consisted in 20 sessions of either "Conventional program" (Control group) or "Dynamic Humeral Centering" (Study group). The clinical evaluation included the range of motion measurement, Constant Score, Quick-DASH and Oxford Shoulder Score at 3 months and 6 months. Patients were blinded to the study hypothesis. The assessor of all outcomes was blinded to the interventions.
The rhythm of the physiotherapy sessions was the same in both groups (3 sessions per week for 3 weeks, 2 sessions per week for 3 weeks and 1 session per week for 5 weeks). All patients received passive mobilization of the shoulder without pain and muscle stretching. Each physiotherapy session lasted 30 minutes and included massage or hot physiotherapy in case of VAS (visual analogic scale) of pain superior to 6/10.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: Group S: physiotherapy protocol with Dynamic Humeral Centering.Dynamic Humeral Centering |
| control group | Active comparator | Other: Group C: physiotherapy protocol with Conventional physiotherapy.Conventional physiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Painful shoulder causes by tendinopathy of the rotator cuff (without full-thickness tear)
- Diagnosis based on a MRI (dating less than 6 months)
Key exclusion criteria (5 listed)
- Tendinopathy of the rotator cuff with full-thickness tear
- Stiffness of the shoulder (loss of more than 20° in passive external rotation or passive forward elevation)
- Previous shoulder surgery (less than 12 months)
- Previous subacromial injection (less than 6 months)
- Context of worker's compensation claims
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 |
|---|---|---|
| Group C: physiotherapy protocol with Conventional physiotherapy. | Other | control group |
| Group S: physiotherapy protocol with Dynamic Humeral Centering. | Other | experimental group |
Primary outcome
Functional status of the shoulder
Time frame: 6 months
Functional status of the shoulder evaluated using the Constant \& Murley Score
7 secondary outcomes
Functional status of the shoulder
Time frame: 3 months
Disabilities of the Arm, Shoulder and Hand score
Time frame: 3 months
Disabilities of the Arm, Shoulder and Hand score
Time frame: 6 months
Functional status of the shoulder
Time frame: 3 months
Functional status of the shoulder
Time frame: 6 months
pain
Time frame: 3 months
pain
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Difficulties for enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group C: physiotherapy protocol with Conventional physiotherapy. and Group S: physiotherapy protocol with Dynamic Humeral Centering. in people with Subacromial Impingement of the Shoulder, run by CHU de Reims at 1 site 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 2 inclusion and 5 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 13 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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: Difficulties for enrollment). 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?
Functional status of the shoulder (time frame: 6 months). 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 13 May 2021.