AzTrials
AzTrials

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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

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.

France1 site
  • Chu de Reims

    Reims, 51092

Other trials in France

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.

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 groups in NCT02874105
Study groupRoleWhat they receive
experimental groupExperimentalDynamic Humeral Centering
Receives: Other: Group S: physiotherapy protocol with Dynamic Humeral Centering.
control groupActive comparatorConventional 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.

  1. Functional status of the shoulder

    Functional status of the shoulder evaluated using the Constant \& Murley Score

    Measured: 6 months

Secondary outcomes (7)
  1. Functional status of the shoulder

    Functional status of the shoulder evaluated using the Constant \& Murley Score

    Measured: 3 months

  2. 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

  3. 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

  4. Functional status of the shoulder

    Functional status of the shoulder evaluated using Oxford Shoulder Score, self reported questionnaire (12 questions)

    Measured: 3 months

  5. Functional status of the shoulder

    Functional status of the shoulder evaluated using Oxford Shoulder Score, self reported questionnaire (12 questions)

    Measured: 6 months

  6. pain

    Shoulder pain evaluated using a visual analogic pain scale

    Measured: 3 months

  7. 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.

  1. First posted22 Aug 2016 (estimated)
  2. Study start30 Aug 2016
  3. Primary completion21 May 2019
  4. Study completion26 Feb 2021

Why it stopped: Difficulties for enrollment

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in